42 Rim Jobs

A day in the life: As Senior Software Engineer Inventory Systems, you will be working with a cross functional team to identify functional requirements, design, develop and implement Inventory, Supply Chain and Finance solutions. You will ensure that the Inventory platform is well designed using best practices to meet the scalability and reliability required for growing business needs. Required Qualifications & Technical Expertise: Bachelor's Degree in Computer Science or related field 8+ years in in developing / implementing / customizing Oracle Retail Applications (RMS, ReSA, RPM, RIB, RSE services) Strong knowledge & hands-on experience on Oracle Retail customizations 3+ years experience in Solution Design Knowledge of AWS/Oracle/Azure Cloud technologies is considered an asset Support troubleshooting through solid analytical reasoning Ability to work independently with minimal direction be a self-starter with strong initiative, and ability to manage/execute workload to deliver high quality results. Excellent verbal and written communication skills Experience in Waterfall & Agile methodology Experience working with high performing transaction systems Must Haves: Acknowledges the presence of choice in every moment and takes personal responsibility for their life. Possesses an entrepreneurial spirit and continuously innovates to achieve great results. Communicates with honesty and kindness, and creates the space for others to do the same. Leads with courage, knowing the possibility of greatness is bigger than the fear of failure. Fosters connection by putting people first and building trusting relationships. Integrates fun and joy as a way of being and working, aka doesn't take themselves too seriously.

Job Title: Technical RMS Consultant Work Mode: Remote Experience: 10 to 20 years Job Summary: Looking for a Technical RMS Consultant with expertise in Oracle Retail Merchandise System. Key Skills: - Oracle RMS - Integration Technologies Responsibilities: - Provide expert-level knowledge and support for Oracle RMS - Design and implement integration solutions - Develop and maintain SQL and PLSQL scripts

BODY Duration : project Based Qualification : B.E(Mechanical/Plastic) for Exterior, Interior Years of Experience : between 05 years to 10 years Location : Hinjewadi Phase3, Pune Skills required : UG NX, Teamcenter Salary Band : Band U3 U2 Exterior + Interior + CIW JD To design, modify/generate `A surface, concept generation, drawing & 3D parametric modeling for, o exterior parts like Bumper, Hood, Grill, Mudguard, Splash panel, etc Interior parts like Instrument Panel, A/B Pillar trims, Cabinets, Bunks etc CIW parts like body front end parts, underbody parts, Body side parts, closures & roof system Responsible for Complete project deliverables Should be Multitasking & Innovative for concept design work Good at problem solving & conflict resolution General product design guidelines for sheet metal parts, Injection molded, blow molded plastic parts, composite & RIM (Reaction Injection molding) parts Good Knowledge of sheet metal parts, Injection molded, blow molded plastic parts, composite materials & RIM parts material & processes Plastic parts, Composite parts design & tooling knowledge is essential Composite parts manufacturing process like SMC, FRP, etc Lightweight plastic material like Metton, carbon Fibers processing Part feasibility study for tooling, Draft Analysis Plastic Tooling Tooling direction, draft angle, parting line, Injection mold part details like core, cavity, slider, Lifter, etc Exposure to Manufacturing will be an advantageous Sheet metal tooling knowledge is essential for CIW Method plan generation, Press tool dies details like Blank, Pierce, Draw, Trim, Flanging, Restrike, etc Simulation, part feasibility study, Welding assembly, problem solving Exposure to Manufacturing will be an advantageous Should be conversant with Gap & Flushness requirements, DFMEA, DRD & regulations Should be able to Innovate, suggest & Implement VA/VE, cost reduction Ideas Should be aware of New trends, technology & implementation for Automotive parts Should be able to handle, mentor & guide team members Good working experience in large assembly management, Top down design Should be able to do Packaging / Integration of Body parts with other surrounding parts Good knowledge of GD & T Good at communication (oral & written), Interpersonal & Intrapersonal skills Should be flexible to work at Client site & ready to work in any shift including US shift 2) CHASSIS Responsibilities Exposure in design of Suspension system Knowledge of integration and packaging of Suspension components Must have worked on Suspension articulation Suspension Design capability Exposure to manufacturing process for fabrication / sheet metal parts & surface coating Working knowledge of GD & T and tolerance analysis Working knowledge on ride height calculations Knowledge of casting and forging components Knowledge and working exp of air suspensions Knowledge of suspension components specifications Good Communication Skill Need UG NX experience is a must CAD/CAE Tool skills UG NX 11 Team Center Should be conversant with Modeling, Assembly, Drafting and Detailing Qualification DME/BE MECH/Automobile Relevant years 4 -5 years Industry exposure Miscellaneous If worked with OEM would be added advantage Electrical Design engineer Automotive electrical circuits knowledge and hands on experience on wiring harness drawings Familiar with automotive standards and regulations Preferred hands on experience on harness design tools Hands on experience on PLM, TeamCenter Exposure to auto component assemblies and processes Design & development of wiring harnesses & parts Creating 2D flattening in capital harness, synchronization with capital logic In depth knowledge of Wiring harness de

Job Summary: We are seeking an experienced professional with strong expertise in Oracle Retail Invoice Matching (ReIM) Cloud Service to support the implementation, configuration, and ongoing management of the application. The ideal candidate will possess deep knowledge of Oracle Retail suite processes, with a focus on merchandise invoice matching, procurement, and accounts payable integration. Key Responsibilities: Configure, implement, and support Oracle Retail Invoice Matching (ReIM) Cloud system as part of the Oracle Retail suite. Collaborate with business users to gather requirements and translate them into functional specifications. Manage end-to-end invoice lifecycle , including receipt, validation, discrepancy resolution, and matching rules setup. Design and support integration between Oracle ReIM, Retail Merchandising Foundation Cloud Service (RMFCS) , and external financial systems. Monitor and resolve daily operational and batch processing issues in invoice matching. Provide functional support for 3-way and 2-way invoice matching , tolerances, and matching rules. Prepare test cases, execute functional testing, and support UAT phases. Create documentation for business processes, configuration, and training materials. Work closely with Oracle and IT teams to troubleshoot issues and apply patches or enhancements. Required Skills & Qualifications: 6+ years of experience with Oracle Retail applications , with at least 2 years focused on ReIM Cloud Service . Strong understanding of invoice matching , accounts payable , procurement , and retail business processes . Experience in implementing or supporting Oracle Retail Cloud modules. Proficiency in SQL for data analysis and issue resolution. Experience with integration frameworks (Oracle Integration Cloud, SOA, or other middleware). Excellent problem-solving and communication skills. Ability to work with cross-functional teams in a dynamic, fast-paced environment

Job Description: We are seeking an experienced Veeva Vault professional with a strong background in the life sciences domain to support and lead configuration, implementation, and enhancement activities across Veeva Vault applications. The ideal candidate will serve as a subject matter expert (SME), ensuring all platform decisions align with enterprise architecture and compliance frameworks. Key Responsibilities: Lead the implementation, configuration, and continuous improvement of Veeva Vault applications (any Vault QMS, RIM, PromoMats, etc.). Act as the primary technical point of contact for Veeva Vault platform initiatives, managing end-to-end delivery of configuration tasks. Ensure configuration decisions align with the clients enterprise architecture, data governance, and document management best practices. Collaborate with cross-functional teams (QA, RA, IT, Validation, Business Functions) to elicit, analyze, and translate requirements into scalable Vault configurations. Review and approve configuration changes and customizations to ensure optimal performance, regulatory compliance, and long-term scalability. Govern configuration management practices to maintain system traceability, version control, and adherence to Veeva best practices. Perform impact assessments for proposed system enhancements, focusing on long-term maintainability, audit readiness, and validation implications. Support validation lifecycle activities, including drafting/reviewing configuration specifications, risk assessments, and test protocols (IQ/OQ/PQ). Troubleshoot system issues and coordinate with Veeva support and internal IT teams for timely resolution. Provide SME-level input during integration efforts with enterprise platforms such as RIM, QMS, ERP, and other regulated systems. Mentor and support business users, administrators, and project teams in leveraging Vault capabilities and ensuring adherence to document/data lifecycle governance. Lead and manage Release Impact Assessments (RIA) for each major Veeva Vault release in the context of live applications. Qualifications: Bachelor’s or master’s degree . Minimum of 6 years of hands-on experience in the life sciences domain with expertise in configuring and managing Veeva Vault solutions. Strong understanding of GxP, validation principles, and document/data governance standards. Excellent problem-solving, communication, and stakeholder management skills. Proven experience with system integrations and cross-platform configuration strategies. Veeva Vault certifications (preferred but not mandatory).

Position: RIM Service Desk Global Enterprise Support Location: Pune Department: Remote Infrastructure Management (RIM) Experience: 01 year (Freshers welcome) Shift: 24x7 Rotational Who Can Apply: Recent graduates or candidates with up to 1 year of experience Interested in IT, Cloud, or Cybersecurity Passionate about solving tech issues Key Responsibilities: Handle IT support for accounts, email, VPN, printing, O365, networks, etc. Log and track issues using ITSM tools (e.g., ServiceNow) Perform basic troubleshooting and escalate as needed Follow standard procedures and shift handovers Contribute to knowledge base updates Education & Certifications: Bachelor's in Computer Science, IT, or Electronics Must have or complete within 6 months: ITIL v4 Foundation Microsoft Fundamentals (MS-900 / AZ-900) CompTIA A+ / N+ Basic certifications in Windows, O365, or Networking Technical Skills: Basic knowledge of Windows, Active Directory, O365, VPN, Networking Familiarity with ITIL processes Experience with ITSM tools is a plus Soft Skills: Strong communication (written & verbal) Calm, courteous, and customer-focused Quick learner and a team player

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

Job Title - S&C Global Network - AI - Healthcare Analytics - Manager Management Level: 7-Manager Location: Bangalore/Gurgaon Must-have skills: R,Phython,SQL,Spark,Tableau ,Power BI Good to have skills: Ability to leverage design thinking, business process optimization, and stakeholder management skills. Job Summary : This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Provide strategic advisory services, conduct market research, and develop data-driven recommendations to enhance business performance. WHATS IN IT FOR YOU An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Professional & Technical Skills: - Relevant experience in the required domain. - Strong analytical, problem-solving, and communication skills. - Ability to work in a fast-paced, dynamic environment. What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Additional Information: - Opportunity to work on innovative projects. - Career growth and leadership exposure. About Our Company | Accenture Qualification Experience: 8-12 Years Educational Qualification: Bachelors or Masters degree in Statistics, Data Science, Applied Mathematics, Business Analytics, Computer Science, Information Systems, or other Quantitative field.

Job Title - S&C Global Network - AI - Healthcare Analytics - Manager Management Level: 7-Manager Location: Bangalore/Gurgaon Must-have skills: R,Phython,SQL,Spark,Tableau ,Power BI Good to have skills: Ability to leverage design thinking, business process optimization, and stakeholder management skills. Job Summary : This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Provide strategic advisory services, conduct market research, and develop data-driven recommendations to enhance business performance. WHATS IN IT FOR YOU An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Professional & Technical Skills: - Relevant experience in the required domain. - Strong analytical, problem-solving, and communication skills. - Ability to work in a fast-paced, dynamic environment. What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Additional Information: - Opportunity to work on innovative projects. - Career growth and leadership exposure. About Our Company | Accenture Qualification Experience: 8-12 Years Educational Qualification: Bachelors or Masters degree in Statistics, Data Science, Applied Mathematics, Business Analytics, Computer Science, Information Systems, or other Quantitative field.

Job Title - Life Sciences- Clinical Management Level : 9,11 Location: HYD, BLR, GGN, MUM; Must have skills: Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite Good to have skills: Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials Job Summary : MBA from a Tier 1 institute or rich relevant industry experience 6+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Roles & Responsibilities: Together, lets deliver more effective, affordable, personalized patient outcomes. In this practice, youll help drive our Life Sciences clients strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies , point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with clients business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Professional & Technical Skills: Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication, interpersonal and presentation skills Additional InformationWhats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word come and be a part of our team. About Our Company | Accenture Qualification Experience: 3+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Educational Qualification: MBA from a Tier 1 institute or rich relevant industry experience

This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation, and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations. Serve as point of contact between Amgen's functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective. Contribute to the development of the strategy for communicating with global health authorities. Initiate, lead, and manage process development and improvement. Participation in information system and software update projects as well as ongoing system validations. Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams. Working knowledge of worldwide regulatory submissions in electronic Common Technical Document (eCTD) format, NeeS, and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance, and overall management of Global/Submission Content Plans, reports, and dashboards. Advanced knowledge of Global, International, and Emerging Markets Marketing Application submission requirements, country specifications, and software used. Advanced knowledge of eCTD, eCTD Specifications, and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred). Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM. Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications. Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master's degree and 3-4 years of directly related experience OR Bachelor's degree and 4-6 years of directly related experience OR Associate's degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA.

The Senior Manager of Regulatory Data Management will help shape and implement the system based framework for regulatory data management at Amgen. The role involves leading the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners who use the company Regulatory Information Management system. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance. Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system. Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement. Ensure the team meets key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency. Drive continuous improvement initiatives to enhance service delivery and operational processes. Minimize potential errors by establishing policies & processes for data usage. Supervise the provision of high-quality data processing, system utilisation and data management services to global clients. Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices. Stay abreast of regulatory developments and ensure the team is follows all relevant regulations and standards. What we expect of you Basic Qualifications: Doctorate degree and 2 years of regulatory systems experience OR Master s degree and 8 to 10 years of regulatory systems experience OR Bachelor s degree and 10 to 14 years of regulatory systems experience OR Diploma and 14 to 18 years of regulatory systems experience OR Advanced knowledge of Veeva Vault RIM Proven leadership in regulatory data management Hands-on ability to work on data-centric processes and systems. Strong Knowledge of handling structured and unstructured data Demonstrated excellence in change management and key customer engagement. Preferred Qualifications: Experience with delivering compliance assurance within a large company Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry. 5 years of proven experience in regulatory operations, submission management. Excellent understanding of Regulatory Affairs business complexity and process interdependencies Experience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area. Demonstrated experience in building and leading successful teams. Sharp learning agility and analytical thinking Proven and advanced interaction with global key customers

Description. Sr Regulatory Associate (EU mkt exp, Module 1). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Minimum 3 years of experience in the EU regulatory environment.. Basic understanding of regulatory procedure, including authoring of Module 1 documents, cover letters, and application forms.. Strong knowledge of regulatory systems such as Veeva Vault, DMS and RIMS. Responsibilities. Essential Functions For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:. Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.. Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.. Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.. Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.. Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.. Attends client meetings as needed and builds client relationship in support of projects and deliverables.. Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.. Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.. Assists in training and mentoring of team members depending upon project requirements.. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.. Qualifications. BS/BA degree or equivalent practical experience.. Experience in a work-related area preferred.. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Strong analytical skills.. Ability to work independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Regulatory Consultant (Sterile Experience). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes.. Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems.. Post approval variation experience is mandatory for EU market.. Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions.. Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries.. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.. Preparation of regulatory assessments and submission strategies specific to sterile dosage forms.. Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness.. Provides regulatory support during inspections and audits related to sterile manufacturing.. Change control assessments and preparation of regulatory impact summaries.. Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers.. Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation.. Secondary. Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines.. Effective communication through email and calls with internal and client stakeholders for updates and clarifications.. Supports and mentors junior team members depending on project needs.. Hands-on experience with RIMS/Veeva Vault.. Open to working in cross-cultural and virtual team settings.. Qualifications. Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Mgr, Regulatory Consulting (Portfolio Management -EU). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Works independently to formulate and lead regulatory strategy for a portfolio of products. Manages end-to-end regulatory lifecycle activities such as new MAAs, renewals, RA/CMC variations, HAQs, annual reports, xEVMPD activities, site renewals/GMP clearances, periodic safety reports and safety updates for global markets with extensive experience in EU procedural submissions.. Acts as a representative of the regulatory department with other departments. Manages liaison with cross functional teams and acts as the point of contact for client counterparts. Provides strategic and operational advice to clients.. Acts as a key point of contact for client and regulatory authorities. Arranges, leads, and reports on client and regulatory agency meetings.. Responsible for day-to-day management of project teams and projects. Provides regulatory advice to junior team members.. Participates in quality improvement efforts to increase overall operational efficiency. Lead process improvement initiatives for client projects.. Develops solutions to complex problems. Acts as a resource for technical knowledge.. Robust risk identification, mitigation and escalation. Provide resolution for all kind of risks.. Appreciable experience in RIMS/DMS preferably Veeva.. Provides internal training in appropriate areas of expertise to junior team members and other departments.. Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.. Monitors personal utilization and utilization of direct reports.. Supports business development, including generation of repeat business from existing clients and proposal development.. Conducts regulatory research on projects as needed.. Contributes to the building of regulatory systems and infrastructure needed for GRAS.. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.. Other Responsibilities:. Performs other work-related duties as assigned.. Qualification Requirements. Master’s degree in pharmaceutical sciences. Above 10 years of demonstrated experience in end-to-end portfolio management for drug products with Subject matter expertise in managing EU markets. Comprehensive regulatory knowledge and understanding of pharmaceutical product development.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management and budgeting skills.. Good people management, project management, problem-solving, and decision-making skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Summary. Responsible for leadership of major assignments and client relationships. Responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. Contributes to business development for regulatory functions.. Show more Show less

Description. Sr Regulatory Consultant (Biologics/Biosimilars). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Primary Skills required. Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses.. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications.. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH).. Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development.. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables.. Experience with post-approval changes, tech transfers, and product lifecycle management.. Excellent written communication, scientific writing, and document organization skills.. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars.. Secondary Skills Required. Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance.. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics.. Qualifications. Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Project Role : Quality Engineer (Tester) Project Role Description : Enables full stack solutions through multi-disciplinary team planning and ecosystem integration to accelerate delivery and drive quality across the application lifecycle. Performs continuous testing for security, API, and regression suite. Creates automation strategy, automated scripts and supports data and environment configuration. Participates in code reviews, monitors, and reports defects to support continuous improvement activities for the end-to-end testing process. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText. -The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education