241 Ich Jobs

Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, and timelines. Lead and mentor scientific staff supporting pharmacology operations. Analyze and compile data, ensuring GxP-compliant documentation and reporting. Contribute to the drafting and revision of regulatory documents including investigator brochures and study reports. Toxicology & Safety Assessment Lead toxicology strategy across discovery, preclinical, and clinical development phases, with an emphasis on human risk assessment and elucidation of toxicity mechanisms for novel therapeutic targets. Act as the primary liaison with CROs, overseeing study conduct and coordinating with technical, veterinary, and scientific personnel. Manage outsourced GLP and non-GLP studies to ensure adherence to protocols, regulatory requirements, safety standards, and SOPs. Integrate expertise in toxicology, pharmacology, ADME, and regulatory guidelines to design robust nonclinical safety assessment strategies. Identify and apply innovative approaches to streamline and accelerate nonclinical development timelines. Critically evaluate study protocols, data sets, and reports to ensure scientific validity and regulatory compliance. Regulatory and Cross-Functional Support Lead or support the preparation of regulatory submissions (e.g., IND, CTA, IB, NDA, BLA). Develop and implement program-specific toxicology plans in collaboration with cross-functional project teams to support compound progression. Represent toxicology and safety pharmacology functions on multidisciplinary project teams. Author and review toxicology reports and regulatory documents; contribute to regulatory submissions and interactions with global health authorities. Represent toxicology function on multidisciplinary teams supporting all stages of drug development. Contributes to the development of high-quality regulatory submissions for global clinical trials and marketing authorizations. Communicate findings and recommendations effectively to project teams and senior leadership. Qualifications and skills : Ph.D. in Toxicology, Pharmacology, or a related field. Strong knowledge of regulatory guidelines (ICH, FDA, EMA) and GxP standards. Minimum 5 years of relevant industry experience in preclinical drug development, or equivalent regulatory experience. Proven experience in designing, managing, and interpreting non-clinical safety and efficacy studies. Demonstrated ability to prepare and review nonclinical sections of regulatory documents like CTA, IND, IB, NDA, BLA, etc. Effective leadership, project management, and cross-functional collaboration skills. Willingness to travel as needed. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements: This is a largely sedentary role.

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Who we are The opportunity The manager is responsible for the supervision, preparation, and critical review of high quality regulatory submissions to the regulatory agencies within company timelines and in accordance with regulatory guidelines. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager will be the product manager for the assigned products and will manage life cycle management activities such as variations, renewals, responses to HA queries and prepare packages for submission to Health Authorities in the required markets. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The product portfolio will cover mature innovative medicines. How you ll spend your day Plans Regulatory Submission Tracker of all Life Cycle Management activities Worldwide Markets for the assigned products. Prepare submission strategy as per regulatory requirements in the given markets and works with cross functional teams for final package creation. Manages all operational activities as needed in Teva regulatory systems. Serves as regulatory representative and works closely with Worldwide markets to ensure timely submission; Maintains collaborative partnerships with stakeholders. Scope of Life Cycle Management Activities include all variations, renewals, PSURs, DSURs, RMPs and responses to queries from Health Authorities (EU/US/APAC/Other Markets) Provides input to KPI metrics for submissions and approvals Other projects and duties as required/assigned. Your experience and qualifications Pharm D/MS in a scientific discipline or equivalent education and related experience Master s degree in RA/QA discipline, a plus. Prior experience in managing life cycle management regulatory activities a plus; Ability to work independently and in a global environment with strong communication skills Minimum 8 years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience required with experience in EU/US/Worldwide markets for Manager Role, 8+ years for Senior Manager position Demonstrates an understanding of ICH and Regulatory Guidelines for US, EU and APAC markets. Demonstrates the ability to evaluate regulatory documents and determine appropriate action. Demonstrates excellent verbal and written communication skills. Shares concepts, ideas, information, and suggestions with management, peers and others. Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts. Demonstrates excellent organization skills and the ability to multi-task; detail oriented. Possesses strong critical and logical thinking. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

We are looking forward to work with strong SAP professionals with hands on SAP ATTP along S4 HANA Implementation. Note: Considering 15 days or less as NP. Job Description: Consultant for SAP Advanced Track and Trace for Pharmaceuticals (ATTP) Key Responsibilities: Must have technical knowledge and skills required to implement and manage SAP ATTP solutions effectively, deep knowledge on track and trace compliance with USA regulations, serialization, and data management in the pharmaceutical supply chain. Deep knowledge on configuration of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) for pharmaceutical serialization and traceability, ensuring compliance with USA regulations. Deep knowledge of pharmaceutical industry regulations, including serialization requirements, EPCIS formats. Implement serialization solutions effectively within a pharmaceutical organization's supply chain. Set up and manage serial number management processes in SAP ATTP for precise tracking. Skilled in configuring, implementing, and customizing SAP ATTP solutions to meet compliance needs. Capable of integrating SAP ATTP with other SAP modules and systems for seamless data flow. Effective troubleshooting and problem-solving skills for addressing implementation issues. Strong communication skills to convey complex technical concepts clearly. Project coordination experience in aligning training with SAP ATTP implementation projects.

Description. Regulatory Associate. 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. Essential Functions. Assists with preparation of product development documents including gap analyses and clinical development plans.. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. 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. Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.. Show more Show less

Description. Sr Medical Writer (CTT). 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. Mentors and leads less experienced medical writers on complex projects, as necessary.. Acts as lead for assigned writing projects.. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:. Clinical study protocols and clinical protocol amendments;. Clinical study reports;. Patient narratives;. Clinical development plans;. IND submissions and annual reports;. Integrated summary reports;. NDA and (e)CTD submissions;. Investigator brochures, as well as;. Clinical journal manuscripts, clinical journal abstracts, and client presentations.. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team providing review commentson draft and final documents.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.. Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT). Redaction of protocol and SAP (Statistical Analysis Plan). Qualifications. Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT). Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. 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. Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus. Leading the clear and accurate completion of medical writing deliverables. Managing medical writing activities associated with individual studies. Coordinating these activities within and across departments. Completing a variety of documents, adhering to established regulatory standards. Coordinating quality and editorial reviews. Acting as peer reviewers for the internal team. Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. Performing online clinical literature searches and complying with copyright requirements. Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentoring and leading less experienced medical writers on complex projects. Developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects. 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. Medical Writer II (CTT). 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. Mentors less experienced medical writers on projects, as necessary.. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Working knowledge of drug development process and regulatory guidelines.. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned.. Minimal travel may be required (less than 25%).. Qualifications. Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing.. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries.. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. 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

We are a company dedicated to the audit and certification of national and international standards of quality and sustainability in products and processes.. We have an interdisciplinary team of professionals specialized in each industry and sector, committed to providing the highest quality service in a personalized way, generating long-term relationships with our clients and the community.. Our wide service offer, our extensive network of producers, processors and traders, our presence in fairs and seminars in different countries and our growing internationalization, make LETIS a link to the world.. Brief Job Description:. Audit preparation. Audit report preparation. Responding to technical queries.. Sending Audit Packs to Certifying office within stated timeline. Submission of Updated Audit Logs. Technical accuracy as per guidelines of audits packs. Client Satisfaction. Sociable with good market recognition and understanding. Technical Knowledge on the food sector audited. Presentable with the right mix of authority and convincing capability. Analytical capability and prompt decision making capability. Qualifications:. Essential:. Graduate/ Post Graduate in careers related to Agronomy Engineering or registered Rural Administration Technician, etc.;. To have knowledge and skills in organic production and handling techniques. At least 2 years of experience as an organic inspector in another Certifying Body (preferably in NOP regulations). Intermediate-advanced level of English (B2-C1). Desirable:. Food industry work experience with knowledge/ experience in auditing food safety management systems. with good Communication Skills , pleasing personality and proficient in computer usage. Please note it is mandatory to attach an audit log of audits conducted during your career, as well as professional references.. Show more Show less

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

Job Description Responsible for overall engineering functions of OSD - plant Responsible for O&M of utility,HVAC, Water System and Process maintenance. Responsible for PM I Calibration I Facility maintenance and department safety functions. Responsible for regulatory I statutory audit compliance. Responsible for Preparation of maintenance reports budget and expenses control. Work Experience 20-25 years Education Graduation in Engineering or Electrical B.Tech in Engineering or Mechanical Engineering Competencies

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables function. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies. Train and guide junior staff members on receivables procedures and best practices. Job Requirements Strong knowledge of banking regulations and laws related to receivables. Excellent communication and interpersonal skills for effective customer interaction. Ability to work in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and problem-solving skills to resolve complex issues. Experience working in a similar role within the BFSI industry is preferred.

We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the receivables process to ensure timely payments and minimize bad debts. Develop and implement effective strategies to improve receivables management. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze and report on receivables performance metrics to senior management. Identify and mitigate risks associated with receivables operations. Ensure compliance with regulatory requirements and internal policies. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for working with customers and stakeholders. Ability to analyze data and provide insights to inform business decisions. Proficiency in MS Office and other relevant software applications. Strong problem-solving skills to resolve complex issues. Experience in managing and leading teams to achieve business objectives.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.

Description CRA II (Single Sponsor dedicated) Croatia Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes, Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate Demonstrates diligence in protecting the confidentiality of each subject/patient Assesses factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues, Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security Verifies the IP has been dispensed and administered to subjects/patients according to the protocol Verifies issues or risks associated with blinded or randomized information related to IP Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned, Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness Reconciles contents of the ISF with the Trial MasterFile (TMF) Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations, Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan Supports subject/patient recruitment, retention and awareness strategies Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution, For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met Must be able to quickly adapt to changing priorities to achieve goals / targets, May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, Prepares for and attends Investigator Meetings and/or sponsor face to face meetings Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements, Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions, Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required, For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Qualifications Bachelors degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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 Medical Writer II (CSR Narrative exp Only) Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Mentors less experienced medical writers on projects, as necessary, Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision, Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures, Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency, Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables, Serves as peer reviewer on internal review team Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format, Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget, Performs on-line clinical literature searches, as applicable, Working knowledge of drug development process and regulatory guidelines, Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing, Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership, Completes required administrated tasks within the specified timeframes, Performs other work-related duties as assigned, Minimal travel may be required (less than 25%), Qualifications Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only, Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise, Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide, Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach, Strong proficiency in Word, Excel, PowerPoint, email, and Internet, Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information, 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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,

Description Medical Writer II (CSR Narrative) Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Mentors less experienced medical writers on projects, as necessary, Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision, Develops or supports a variety of documents that include but not limited to: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; Annual reports; Investigator brochures, Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency, Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables, Serves as peer reviewer on internal review team Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format, Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget, Performs on-line clinical literature searches, as applicable, Working knowledge of drug development process and regulatory guidelines, Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing, Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership, Completes required administrated tasks within the specified timeframes, Performs other work-related duties as assigned, Minimal travel may be required (less than 25%), Qualifications What were looking for Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only, Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise, Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide, Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach, Strong proficiency in Word, Excel, PowerPoint, email, and Internet, Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information, 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, 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,

Description CRA II (Sponsor dedicated) Athens Homebase Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes, Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate Demonstrates diligence in protecting the confidentiality of each subject/patient Assesses factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues, Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security Verifies the IP has been dispensed and administered to subjects/patients according to the protocol Verifies issues or risks associated with blinded or randomized information related to IP Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned, Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness Reconciles contents of the ISF with the Trial MasterFile (TMF) Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations, Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan Supports subject/patient recruitment, retention and awareness strategies Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution, For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met Must be able to quickly adapt to changing priorities to achieve goals / targets, May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, Prepares for and attends Investigator Meetings and/or sponsor face to face meetings Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements, Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions, Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required, For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Qualifications Bachelors degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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 Quality and Compliance Assessor Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Performs Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and/or Sign Off Visits (SOVs) as assigned, Assists in the analysis of qualitative oversight data to identify quality improvement signals, Conducts root cause analysis of the quality signals and develops a plan and/or recommended action(s) that may include assisting with implementation of process and efficiency improvements, Identifies training needs for CRAs through the analysis of aggregated oversight data to meet expected standards in quality and efficiency across Global Clinical Operation (GCO), May conduct training on areas of improvement as identified through the quality oversight data analysis and/or audit and inspection findings in collaboration with Learning Center of Excellence, Corporate Quality and Clinical Operations Management, Supports Clinical Operations in addressing ad hoc or escalated quality concerns within region, Acts as consultant to local/regional operations related to quality oversight best practices and tools, May assist in the review of Clinical Monitoring SOPs, tools or templates related to monitoring oversight, Performs other work-related duties as assigned, Requirements Bachelor's degree in biological science or healthcare-related field required Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech or large pharmaceutical company Additional industry experience as a CRA Line Manager, Project Manager, Clinical Team Manager or Quality Control role preferred In-depth knowledge of ICH/GCP, local regulations, drug development process and clinical operations required Knowledge of multiple therapeutic areas Must be able to work independently within a matrixed environment across multiple projects, geographical locations and organizational levels to accomplish business goals Strong attention to detail with excellent organizational, documentation and presentation skills Strong interpersonal and communication skills with the ability to identify and solve problems and communicate issues tactfully Ability to perform root cause analysis Ability to manage required travel of up to 75% on a regular basis; including internationally Proficiency in written and spoken English with additional languages preferred in regional locations where the assessor will support multiple countries 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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 The Quality and Compliance Assessor will collaborate with Clinical Research Associate ?CRA? line management to conduct quality oversight activities of CRAs to achieve consistent, high-quality performance and output for our clients Coordinates analysis of aggregated quality oversight data and communicates findings to CRA line management and Clinical Operations leadership with critical attention to addressing issues with solution-oriented proposals,

We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the receivables process to ensure timely payments and minimize bad debts. Develop and implement effective strategies to improve receivables management. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze and report on receivables performance metrics to senior management. Identify and mitigate risks associated with receivables operations. Ensure compliance with regulatory requirements and internal policies. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for working with customers and stakeholders. Ability to analyze data and provide insights to inform business decisions. Strong problem-solving and analytical skills to resolve complex issues. Experience with accounting software and systems is desirable. Ability to work in a fast-paced environment and meet deadlines.

We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the receivables process to ensure timely payments and minimize bad debts. Develop and implement effective strategies to improve receivables management. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze and report on receivables performance metrics to senior management. Identify and mitigate risks associated with receivables operations. Ensure compliance with regulatory requirements and internal policies. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for working with customers and stakeholders. Ability to analyze data and provide insights to inform business decisions. Proficiency in MS Office and other relevant software applications. Experience in managing and leading teams to achieve business objectives. Strong problem-solving skills to resolve complex issues and improve processes.

We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the receivables process to ensure timely payments and minimize bad debts. Develop and implement effective strategies to improve receivables management. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze and report on receivables performance metrics to senior management. Identify and mitigate risks associated with receivables operations. Ensure compliance with regulatory requirements and internal policies. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for working with customers and stakeholders. Ability to analyze data and provide insights to inform business decisions. Proficiency in using accounting software and systems for managing receivables. Strong problem-solving skills to resolve complex customer issues. Experience in managing and leading a team to achieve business objectives.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products and services. Excellent problem-solving and analytical skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Familiarity with industry-specific software and systems.

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes, Analysis of Regulations, Guidelines, Policies, Important order, etc to derive meaningful insights & actionable for higher management, Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority, Support in review of bidding, bid documents, RFS & PPA, Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks, Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives, Building positive relationships with stakeholders, associations, etc through appropriate management of expectations and objectives, ensuring consistent and effective communication, Will handle the Invoicing, NFA, payment disbursement activities, etc Draft representations, communication for various stakeholders, Additional Responsibilities: Supporting corporate communications efforts with different stakeholders, Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence, Business Unit: T&G Division: T&G AMEA India Legal Entity: ENGIE Energy India Private Limited Professional Experience: Junior (experience < 3 years) Education Level: Bachelor's Degree

As part of a global team, you will be the second level contact to support our commercial organizations/customer facing functions with quality & regulatory knowledge for our global Life Science product portfolio. You will assist and advise our customers on quality and regulatory topics such as but not limited to providing consultative services and documentation support. You will interact with various internal functions (e.g. Quality, Regulatory, Business) to come up with resolution to address our customers Quality (Q) & Regulatory (R) related inquiries. Being the interface between customers and our internal functions, you will give advice to our customers as well as our internal stakeholders, explain complex topics including to non-experts and support the development of market leading solutions. Create/Continue to improve our digital solutions and workflows with aim to achieve better customer satisfaction. As a Subject Matter Expert for a specific group of product portfolio and/or Quality/Regulatory topic, you will drive the continuous improvements and implementation of digital workflows to improve our service level support. Who You Are: Masters Degree in Life Sciences, Chemistry, Biology, or equivalent. Minimum 4 years professional working experience in a customer service-oriented environment in Life Science, Biotechnology, or related industry. Good understanding of quality & regulatory guidelines is a plus especially for pharmaceutical raw materials (e.g. Excipient & API). Digital savvy in using digital tools are necessary and important in daily work. Proficiency in using relevant software applications such as SFDC, SAP & Microsoft 365. Act as a voice of our customers by advocating the importance to support when necessary and work with relevant stakeholders to find feasible solutions to resolve challenges faced. Global mindset and willing to attend global calls outside office hours (e.g. night calls). APAC regional exposure experience will be an added advantage.