178 Medical Affairs Jobs - Page 2

The Senior Medical Affairs Manager (MAM) is an experienced field-based member of the Medical Affairs team who serves as a strategic link between Alcon and Medical Experts (ME)/Key Opinion Leaders (KOLs) in the field of Ophthalmology and Optometry. The Senior MAM strategically supports the development and appropriate use/adoption of Alcon products and therapies through supporting evidence generation and evidence-based scientific exchange and by gathering actionable insights to further inform and shape the company's understanding of the products, therapeutic area, market access, and clinical practice. The Senior MAM responds to unsolicited requests for scientific exchange/insights, detailed working knowledge of FDA-approved Alcon products, current medical/scientific research, and publications and proposals for scientific research. The Senior MAM provides support for ECPs interested in participating in ALCON's Investigator Initiated Trials (IITs) by guiding them through the concept endorsement, synopsis review, and grant approval process, and acts as an end to end study liaison. The Senior MAM serves as a mentor to onboard new MAM and experienced team members in scientific subject matter and KOL/IIT management skills. The Senior MAM provides general medical/healthcare information by delivering unbiased scientific information (data dissemination) presentations to practitioners, third-party payors, and internal Alcon associates. The Senior MAM also responds to queries and unsolicited requests for medical information from doctors submitted to Medical Product Information and Complaint Handling and escalates to the MAM's team. The Senior MAM provides important information for making healthcare coverage and access decisions for Health Economics and Outcomes Research. Foster KOL/HCP interest in Investigator Initiated Trials (IITs) within Alcon's product strategy and liaise between potential researchers and Alcon on Investigator Initiated Trials (IITs) from inception to publication. Act as an interface between Medical Expert/HCP and Alcon to provide up-to-date medical support on device-related issues to educate, diagnose, resolve, and where applicable, escalate to local or regional Medical Affairs. Develop and maintain peer-to-peer scientific relationships with KOLs and decision-makers to expand evidence generation through scientific partnership opportunities; and gain their advocacy. Develop a strong understanding of the future needs of ophthalmic surgeons and support medical education in alignment with Alcon's strategy. Identify national, regional, and local KOL eye care provider experts according to their medical expertise and academic reputation. Liaise and provide up-to-date medical support to healthcare associations to ensure an evidence-based understanding of Alcon products relative to medical guidelines and medical evidence/health economic information. Assure thoughtful and informed exchange of current medical information and data related to Alcon products and selected areas of therapeutic interest with KOLs. Provides important information (HEOR/data) for payers making healthcare coverage and access decisions. Regularly collect, analyze, and report insights from the scientific exchange with ECPs that may impact company development plans/trial designs, launch, and brand strategies/tactics. Deliver effective presentations to ECPs and collect and report insights. Function as the Alcon medical speaker to present, as needed, at customer sites, ad board congresses, symposia, and training events for up-to-date data-based, scientific, and clinical information on Alcon product(s). Provide non-promotional speaker training to HCPs to support education/medical events to the healthcare community about therapies/devices developed and commercialized. Medical Support & Key Opinion Leader (KOL) Relationship Development Attend and provide scientific support for Medical Affairs activities and scientific sessions at regional and national congress meetings. Liaise and provide up-to-date medical support to healthcare associations to ensure an evidence-based understanding of Alcon products relative to medical guidelines and medical evidence/health economic information. Timely completion of all required training activities, documentation, and other administrative responsibilities. Deep scientific and KOL/IIT management skills that are used to coach and onboard new MAMs and team members Acts in lieu of a MAM Regional Director as a peer mentor, as a subject matter expert and possesses excellent operational excellence (time, budget/finance, data standards, reports etc) Internal Alcon Support Provide medical support and training, as appropriate, (i.e., disease state and product) to colleagues (e.g., sales reps, Regulatory Affairs colleagues, etc.), but not as a substitute for those functional training groups. Support educational efforts, such as wet lab activities, by proctoring such events and being onsite as necessary. Ensure cross-functional collaboration, and interface effectively with all other Medical Affairs functions, as well as other departments, including but not limited to Commercial, QA, Research and Development, Regulatory Affairs, and Market Access. Work with Med Info and Med Safety to help resolve escalated product complaints as well as Medical Safety issues. Comply with all credentialing requirements for any healthcare institution (e.g., hospital) that is part of the MAM's call plan, including, among other things, routine background checks, medical testing (i.e., Tuberculosis test) or proof of immunizations, training on facility policies, adherence to confidentiality, etc. Work with Integrity and Compliance observing all laws, industry standards, and company policies. Key Performance Indicators Number and quality of support for Investigator Initiated Trials, with documentation Key Performance Indicators (KPIs) for an associate in this role measuring progress and performance are aligned and set in accordance with: Organizational Objectives and Goals Departmental / Team Objectives and Goals Individual Objectives identified during the Performance Management Process Integrity and Compliance KOL Engagement and Relationship Management Quantity and quality of Investigator-Initiated Trials (IITs) submitted proposals in alignment with ALCON's Global Medical strategy Quantity and quality in the execution of Investigator-Initiated Trials (IITs) and other research project proposals received and successfully implemented Impact of the Research Proposals Quantity, quality, and content of monthly KOL interactions and presentations with scientific purpose Quantity and quality of support to KOLs presenting on Alcon products (e.g., Advisory Boards and other non-promotional meetings) Quantity and quality of new KOL relationships Ability to effectively address clinical questions and product complaints Quantity and quality of insights collected and reported from the scientific exchange with ECPs Quantity and quality of Identified KOLs who are qualified for Medical Affairs and R&D activities Quantity and quality of insights collected by the MAM at attended congresses, symposia, and training events Quantity and quality of podium presentations delivered at congresses, symposia, and training events Quantity and quality of SoV opportunities generated in the assigned territory Quantity and quality of events supported (such as presentations, webinars, focus groups, user meetings, advisory boards, symposia, customer training events) Training compliance report for the MAM MAM's Evaluation from internal stakeholders Contributions to educational materials, and impactful internal training presentations MAM's feedback from KOL and other HCP Level of collaboration and successful execution of integrated initiatives Quantity and Quality of Healthcare Economics presentations delivered internally and to payors Effectiveness and frequency of mentoring and training new MAMs, KOLs, and team members

Jobsguru looking for a Medical Advisor for our pharma client in Mumbai. Contribute to the development of the medical components of the Brand Strategy and develop a Medical Plan. Mail CV search@jobsguru.in 9302574002 Shreya Jobsguru Consultant P Ltd Required Candidate profile Should be M. Pharma Excellent presentation and teaching skills Highly effective communicator both oral and written Can develop training material Excellent presentation and teaching skills

Description Sr Medical Writer (Redaction) 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 Authoring andQuality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i-e , clinical study reports, patient narratives, clinical summaries etc for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2 Additional Activities Completion of Internal and Client specific training Assist in mentoring and training of team members depending upon project requirement(s) Qualifications We are looking for 4-8 yearsexperience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) Candidate should be well versed with all the related regulations, perform quality review, client communication and management, Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials gov and for various other clinical registries will be added advantage Resource should understand & comprehend protocol and clinical study report from disclosure perspective Good understanding of Clinical Trial Disclosure fundamentals is expected Qualification Requirement Educational qualifications: A minimum of a scientific graduate degree in life sciences, Good knowledge of regulatory requirements or guidance pertinent to the service line, Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines Clear written and verbal communication skills Good knowledge of basic computer applications, e-g MS Word/ PowerPoint/ Excel, will be required, Person should understand & comprehend protocol and clinical study report from disclosure perspective, Good understanding of clinical trial disclosure fundamental Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working Ability to build rapport/ relationships with project-specific client colleague 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,

SBO Manager (HEVA) will be functionally aligned to Global HEVA business partners (BPs)/Global HEVA Evidence Synthesis lead and will support execution of multiple activities Manage assigned Evidence Synthesis projects in the assigned portfolio to plan and generate robust health economics and value based evidence to maximize the value propositions from both a global and US perspective working within the Market Access tripod by working with Global HEVA BPs/Global HEVA Evidence Synthesis lead Work with Global HEVA BPs/Global HEVA Evidence Synthesis lead to manage and execution of quality research projects, economic models, trial design recommendations and other activities in support of programs/products as required Support HEVA BPs/Global HEVA Evidence Synthesis lead in the planning, design, implementation, and completion of innovative evidence-based research programs that are consistent with program/product strategies. The research programs developed by Global HEVA BPs will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle Collaborate with Global HEVA BPs/Global HEVA Evidence Synthesis lead to seek opportunities to innovate HEVA value identification, evidence generation and dissemination process/plan to increase the relevance and impact of HEVA evidence to ensure reimbursement decisions optimal access Create complex and specialized strategic content without supervision Develop and maintain TA expertise Develop and review content created by HEVA associates Coach HEVA associates People: (1) Develop and maintain effective relationships with key internal stakeholders including Medical Affairs, Clinical Development, Commercial and Market Access (2) Constantly assist and provide effective feedback to HEVA associates (senior or junior) in developing knowledge and sharing expertise (3) Work effectively with global HEVA teams across various time zones Performance: (1) Manage the HEVA evidence generation projects in collaboration with Global HEVA BPs: Develop research plan to support pre-launch, launch and post-launch evidence for investigational and marketed drugs; Evidence generation plan includes burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, development and analysis of patient-reported outcomes; Provide strategic support with individuals and institutions, which may serve as resources for evidence generation purpose, etc; Work closely with the HEVA product lead to manage and execute research studies to support the clinical, economic and humanistic value of products; Studies include but are not limited to burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes; Lead development of core value dossier (CVD) and AMCP dossiers under the strategic direction of Global HEVA BPs Process: (1) Develop complex HEVA strategic evidence material (2) Build expertise in the field of HEVA for the assigned Therapeutic area (3) Manage core HEVA strategic evidence generation processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with CVD, the US AMCP dossier, and HEVA contributions as appropriate to other submissions (4) Accountable for adherence to the evidence generation guidelines and other standards relevant to HEVA evidence generation processes at SBO (5) Leverage advanced training delivery tools & techniques thereby enhancing the effectiveness of training delivery (6) Design an overall plan of action basis end-customers feedback & improve course content and delivery Stakeholder: (1) Work closely with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs and Market Access global or local teams in regions/areas to identify evidence generation and dissemination needs and assist in developing assigned deliverables (2) Liaise with these teams to prepare relevant & customized deliverables and ensure milestones and timelines are on track for assigned the projects About you Experience : 8+ years of experience in HEOR for the pharmaceuticals industry, CRO consultancy or academia. Soft skills : Demonstrate effective communication, organizational and interpersonal skills; Able to work effectively as part of a multidisciplinary global teams; Able to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law; Ability to handle multiple projects across different therapeutic areas; Ability to work we'll in a cross-functional team; Understanding of the disease environment and the evolution of the market access landscape and implications for the business; Proven track record working successfully in a project/matrix-oriented environment; Excellent communication skills and ability to understand and present complex information in digestible ways for internal (eg senior management) and external audiences; Strong team spirit, sense of transversality, multicultural awareness and ability to drive matrix teams Technical skills : Strong analytical skills to translate clinical and economic information and messages into payer evidence strategies; Understands reimbursement decisions to determine value drivers and how evidence is used in decision making and how it impacts various payers (eg, providers, patients, health systems); Knowledge of methods and principles of health economics, health technology assessment (HTA) reviews Education : Advanced degree in life sciences/pharmacy/similar discipline or medical degree Languages : Excellent knowledge of English language (spoken and written)

Your Opportunity The Manager - Oncology is responsible for planning and implementation of Medical Activities aspects of the Roche Diagnostics India Affiliate medical plan for the Oncology diagnostics products in core, molecular and tissue diagnostics. This position will report to Head - Medical Scientific & Regulatory Affairs Key Accountabilities The key accountabilities for this position include, but are not limited to: Accountable for defining the strategy for Medical Activities and collaboration as part of the overall medical strategy and its implementation, in alignment with the commercial strategy Contribute to overall annual and ongoing medical planning including input on situational analyses and strategy Build strategic partnerships with relevant external experts like oncologists, pathologists, and other relevant external stakeholders Drives HCP/KOL engagement initiatives at forums such as Roche initiated medical education programs, scientific congresses and advisory boards Ensure all the medical interaction and activities are compliant with the Dia Symphony guidelines, company SOPs, local Codes of Practice and regulations, and put patients at the center of actions Deliver credible code-compliance medical presentations to HCPs, individually or in groups, either reactively (in response to a medical enquiry) or proactively (to disseminate scientific data best aligned with business needs) Who You Are We are looking for a medical professional with a relevant expertise in the Healthcare Industry or a related field. You hold a degree in Medicine, MBBS, MD, pathology, oncology, or other medical related degree in life sciences You have a minimum of 5 years of proven experience in medical affairs You have a experience in Oncology, Pathology & Genetics therapeutic areas Experience in working with clinicians, KOLs and scientist, and have documented records of HCPs education and interactions Advanced communication, presentation, lecturing, teaching skills, and able to facilitate high level health stakeholders interactions Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first. Closely working with commercial, APAC and global teams to identify mutual value and opportunities for collaboration. Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is essential. Who we are . Let s build a healthier future, together. Roche is an Equal Opportunity Employer. "

The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data. What You ll Do: Work actively in risk management activities, including risk management plans, referrals, signal detection and medical writing to support product safety reviews and clinical evaluations. Work actively in identifying and processing signals for all ADVANZ PHARMA products as been assigned within the stipulated time. To prepare Signal reports (including PAS, DSR, SAR as applicable) and maintain the compliance and quality of signal detection. Act as a Safety contact point on all matters relating to Safety agreements with license business partners including the handling of confidential information and negotiation of the agreements with commercial and co-development partners. Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties. Track and maintain oversight on all assigned Safety agreements. To update SDEAs on a regular basis, coordinate in the completion of business partner responsibility tracker, to identify gaps in the templates and process, make appropriate changes if required. Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Supply, Commercial, Legal) as well as external business partners. Actively coordinate with all the internal and external stakeholders to ensure Pharmacovigilance and regulatory compliance. Involvement in pre and post action arising from PV audits and inspections Keeping abreast of changing PV requirements globally. Contribute towards continued improvement of safety systems and processes. Ensure all documentation is structured and maintained as required. Compliance with GPvP and company requirements, demonstrated through audits and inspections. Perform regulatory intelligence activities. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Tertiary qualification in any discipline within Life sciences or Pharmacy. Post-graduate qualification (e.g. Masters) in an industry relevant field. Knowledge, Skills Experience: Must have significant experience in Drug safety or Pharmacovigilance activities. Proven ability to analyze scientific data. Medical Writing experience (e.g. PSURs, Safety variations, RMPs, Clinical and Non-Clinical components of product dossiers). Experience in Compliance tracking (e.g. PSMF, safety databases) and Pharmacovigilance Audits. Open and adaptable to challenging environments. Ability to work with different Global culture and different time zones. Excellent attention to detail and innovative solution finding ability. Excellent communication skills. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others. A positive and can-do approach , biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.

The Global Scientific Communications Content Hub is a growing, high performing, collaborative team responsible for developing medical communications, medical education and medical information content in close collaboration with a range of teams across Healthcare. The team is based in Global Healthcare's multi-disciplinary R&D (Research & Development) Hub in Bengaluru and working together across our global medical units (Oncology, N&I, Fertility, CM&E and Global Health). We are seeking experienced, passionate scientific writing professionals who would like to develop their career and contribute to the continued growth of our operations. Your Role: Working both independently and alongside other team members to develop medical content for a range of project types, audiences and writing styles including, but not limited to, medical communication content (including publications and congress materials) and medical education content Actively contribute to improvement initiatives across the Global Scientific Communications Content Hub Lead development of medium to high complexity content (and review the same produced by others) Review (QA) the output of less senior writers (including scientific accuracy, tone and alignment with agreed strategic messaging) Lead concept and content development meetings with authors and other stakeholders. Lead representative/SMEs for the assets/functional areas they are assigned on; develop programs to increase the depth of understanding of more junior writers Maintain good relationship with stakeholders (e.g. within MUs) Ensures personal efficiency and productivity targets are met Manages and prioritizes workload to meet internal deadlines Ensures status reporting of projects is clear You will have: 9+ years professional experience in medical communications/medical affairs/clinical research in an international Pharma/Biotech/agency setting A proven track record of successful scientific writing and leading projects; are comfortable with developing a range of content types, sometimes concurrently, and able to prioritize tasks to meet timelines/deadlines An advanced university degree in science, medicine or another related subject Therapeutic expertise/experience in one or more of Organization's key therapy areas (Oncology, Neurology and Immunology, Fertility, Cardio-metabolic and Endocrinology) Demonstrable stakeholder management expertise Strong awareness of the pharmaceutical business and trends in the industry Experience in managing projects cross-functionally and in an international setting Strong analytical skills and ability to understand complex processes, project management and project leadership skills Excellent verbal and written communication skills (English language)

Job Purpose The Regional Medical Coordinator/Manager is responsible for being the key clinical resource in a region for delivering scientific presentations to healthcare professionals and developing relationships with key decision makers. This position reports directly to the Senior Medical and works closely with the regions Senior Sales Manager, Business Manager and local Sales Representatives. Achieve scientific proficiency to drive the development of assigned therapy areas in accordance with the medical strategy Keep abreast with the latest medical developments through publications, websites and by attending regional conferences. Understand on ground clinical practices by interacting with clinicians, to develop practical knowledge and utilize it to provide closer-to-market product solutions Create scientific publications on their therapeutic areas Identify the need, plan for, and select faculty, for organizing regional advisory boards, RTDs, CMEs, symposia, webcasts, conferences etc., working closely with the sales team. Ideate and conceptualize and execute with sales team and HO medical to develop regional strategies to drive India business Provide clinical/scientific and ethical guidance to marketing, sales for diseases/therapies/products strategies driven by head office Trains and coaches sales and colleagues in the scientific matters and provides medical expertise in addressing queries or issues encountered by field force. Develop and maintain professional relationships with prominent Key opinion leaders within designated territory. Deliver fair, balanced, and objective clinical and scientific presentations to healthcare professionals Attend national and regional medical meetings and symposia and engage in discussions with attendees as appropriate, Identify speakers for advisory boards, symposia, and educational programs Conduct local and regional Advisory Boards, round tables and educational programs that aim to satisfy the specific needs of key healthcare professionals and institutions. Provide input to management regarding alternative products , business development opportunities/risks, and customer feedback. Ideate and execute investigator initiated trials. Provide assistance to HO initiated trials Identify therapeutic gaps in the product portfolio and suggest new molecules/ formulations/ incremental innovations in order to contribute towards building a robust therapy-product mix Identify, analyse and recommend new molecules, devices and products for the domestic and global business, by studying market trends Provide a medical opinion and rationale to assist the portfolio Develop protocols for research projects in liaison with clinical trials department and get approval from group lead Build sales team capability by conducting training sessions and guiding team members on how to develop their competence Conduct medical trainings of sales team Develop induction training program with content for new sales team members Track effectiveness of trainings regularly by means of feedback Build external advisor relationship to help steer the therapy market Identify new KOLs and initiate contact with them Engage existing and new KOLs through various scientific activities Leverage KOLs and therapy consultants for strategy development, training and understanding therapy landscape as well as for potential hiring Ensure ethical actions by adhering to regulations and laws Ensure compliance and adhere to internal policies, local and international regulations for scientific, promotional materials, activities and therapy/ product related queries from internal and external stakeholders Major Challenges Keeping pace with the frequently changing compliance requirements, market dynamics/ therapy treatment trends and medical information overload Managing multiple stakeholders and interdependencies on other cross functional teams Key Interactions (1/2) Marketing Team (as required) Sales Team (Regional) for field queries, CME meetings and refresher, launches, joint field work, monthly meetings, etc. (daily) Clinical Trials for discussions on trial protocols, status and other inputs (need based) Compliance & Ethics to ensure promotional activities in line with compliance guidelines (need based) Learning and Development for Esproute related & training (need based) Library (need based for research articles) Corporate Communications & CiplaMed for therapy related inputs (need based) Key Interactions (2/2) Conference Committees for publications, lectures, posters etc. for conferences (need based) Chemists for competitor insights and patient feedbacks (bi-monthly) DCGI for product approval presentation (occasional) KOLs for knowledge sharing (need based) Medical and nonmedical institutes/ associations/ Paramedics to partner in research projects, educational activities, etc. (need based) Sales Team: Daily Dimensions (2/2) KOLs developed as speakers in Regional / National / International programmes. No numbers. Competitor intelligence Active participation in Symposia / conferences held in their region Field force support in handling difficult KOLs FF training FF in-clinic assistance Active participation in regional strategy meets and monthly meets Sales targets (Bharat serum and Abbott Nutrition) Assistance for HO initiated programmes and HO initiated Clinical trials Assistance in rolling out HO strategy in region Regional Brand Launches Regional Compliance Education Qualification MBBS/ MD Relevant Work Experience 0-2 years experience with PhD/ MBBS/ MD

Rama Group require an experienced and energetic Medical Director to oversee the whole medical operation and growth of the hospital services. Ideal candidate should have rich experience of working at same position of Medical Director in any good hospital setup. Medical Director has to ensure the efficient operation of our healthcare facility. Oversee the doctors team, IPD, OPD services management and provide solution on time. Should have good idea and clear approach. Candidate may apply through whatsapp at HR number also 7275254108

Clinical Operations Manager POSITION PURPOSE The COM 2 is a regional role that provides expertise across a ll aspects of clinical site management and/ or study management for assigned Phase I - IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer s standard operating procedures. The COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities. A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer s standard operating procedures, including any requirements for independent review and oversight. ROLE AND RESPONSIBILITIES STUDY MANAGEMENT Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive. Serve as the representative for site management on the core study team. Contribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects. Responsible and accountable for developing the monitoring plan and the study-specific training plan. Key contributor in the development of recruitment and retention strategies and tools. Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries. Ensure participating country commitment aligns with study commitments. Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data. Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits. SITE MANAGEMENT Act as primary contact for investigational sites. Verify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out. Train the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct. Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File. Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up. CLINICAL CUSTOMER ENGAGEMENT Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement. Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities. Cross functional collaboration to ensure alignment of priorities and deliver the portfolio. Influence and challenge internal and external factors to improve clinical research delivery. STUDY START-UP Lead study start-up activities in collaboration with local team. Provide input on site activation strategy. Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. Compile and submit submission dossier (country dependent). Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures). Prepare and distribute site start up documentation including Investigator Site File. Ensure timely filing of study documents at country and site level in Trial Master File (TMF). Ensure awareness of related local regulations and support maintenance of country intelligence. Provide study status monitoring and systems support (e.g. act as technical expert) Coordinate site and vendor payments. QUALITY Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data. Maintain corrective action and preventative action plans (CAPAs) at country level. Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome. Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs. OTHER Participate in expert working groups, project standard teams, and similar initatives. Contribute to global process improvement efforts. Share knowledge and experience with a coaching mindset Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel. KEY WORKING RELATIONS: Internal: Locally and regionally with other COM 2s, medical affairs, pharmacovigilance, regulatory affairs, legal and other functions. Globally with study team members, QA & Inspection management. External: With site personnel, third party vendors, health authorities, IRB/EC, and inspectors, thought leaders including steering committee members, national leaders and/or other committees. WHO YOU ARE: Healthcare related Bachelor s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Other qualifications: Fundamental project management skills Awareness & understanding of cultural and regional differences Communication, oral presentation & interpersonal skills Decision making Issue resolution Planning and organization, time management, prioritization Thrives in ambiguous and collaborative environments and embraces change Effective written and verbal English communication skills Willingness to travel to sites, study meetings, local and international level Ever feel burnt out by bureaucracy? Us too. That s why we re changing the way we work for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . Location: India : Karnataka : Bangalore || India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 848115 Contact Us + 022-25311234

Primary responsibilities 1.Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects 2.Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3.Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1.Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2.Review of clinical and non-clinical overviews and summaries of CTD 3.Review of medical rationale for CT waiver applications 4.New products evaluation for development 5.Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6.Mentoring/ training team members to gain required skills to enable on-time deliverables.

Job Title: Associate Global Development Scientist Director, Late Development Oncology Global Career Level: E Introduction to role: Are you ready to make a difference in the world of oncology? The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA). The Global Development Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Accountabilities: Clinical Development Responsibilities - Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. - Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross-functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Serves as contact with vendors and CROs regarding medical/clinical science issues. - Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc., and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study. - Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information are shared with cross-functional study team. Support review of safety narratives. - Supports preparation of abstracts, manuscripts, publications, and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities. - Assists with drafting assigned sections of clinical reports, dossiers, and other documents. - Support Data Management in the build of the CRF and all associated instructions and plans (e.g., CRF completion instructions and Data Review Plan). Technical Skills - Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct, and description of clinical research at a study level. - Ability to understand and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentations. Demonstrates solid understanding of methodology in the design, conduct, and interpretation of clinical research. Outstanding attention to detail and outstanding written communication skills. - Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g., the protocol, CRF, data listings, TLF, CSR etc.) - Ability to analyze and summarize clinical results. Support creation of and review of clinical slides for internal and external meetings. Essential Skills/Experience: - Required Life Sciences degree or equivalent - PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience - Industry or academic experience in drug development required. - Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. - Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals. - Ability to grow and maintain a high level of expertise in oncology therapeutic area. At AstraZeneca, we are driven by a mission to transform cancer treatment through innovative approaches like novel biomarkers, AI, novel endpoints, and cutting-edge trial designs. Our collaborative environment empowers you to take smart risks and challenge norms while working alongside top experts globally. With one of the broadest oncology pipelines in the industry, youll have opportunities to work with new drugs that truly improve patient outcomes. Ready to join us on this exciting journey? Apply now to be part of our transformative team! 12-Jun-2025 17-Jun-2025

Senior Manager , Marketing The Senior Manager, Marketing will lead the marketing strategies for our cardiovascular (CV) portfolio. This position involves developing and executing comprehensive marketing plans for selected assets in the CV portfolio that align with corporate goals and address the needs of healthcare professionals and patients. This role will report into the Associate Director and will be based out of Mumbai. Key Responsibilities: Brand Planning: Identify and develop pre-launch strategies, marketing plans and growth levers Develop and implement strategic marketing plans and Campaigns for select CV products, ensuring alignment with corporate objectives and market demands Conduct market research and competitive analysis to identify trends, opportunities, and insights that inform marketing strategies Support Clearsight modelling and, market share analysis and devise strategies to increase brand share Conceptualize and design marketing content E.g. Detail aid, LBL, Lama, speaker decks, campaign visuals etc. Work alongside cross-functional teams including sales, medical affairs, and regulatory teams to ensure cohesive execution of marketing and pre-launch strategies Conceptualization, planning and nation-wide implementation of novel marketing engagements in line with business needs. E.g. innovative HCP education, Media, Patient awareness, Disease awareness etc. Marketing Execution: Support Monthly Business Reviews for assigned zone cross functionally which includes data analysis, Account level analysis, Market share analysis, Prescriber analysis etc. Manage HCOs including negotiation, documentation, post event closure etc. Manage ISPs end to end including selection of international expert, logistics, conducting nationwide tours, post event closure etc. Job Requirements: Individuals with strong background in marketing (cardiology/critical care/rare diseases preferred)/ experience leading marketing for multimillion brands / management consulting experience / experience leading pan-India sales for multimillion brand (either is mandatory) Excellent organizational and project management skills Outstanding written and verbal communication skills Strong critical thinking and problem-solving skills Demonstrates behaviour consistent with high integrity and strong values Experience with launching new products is preferred Education: Master s or higher (Business and / or Policy preferred) Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Preferred Skills: Job Posting End Date: 06/27/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Role & responsibilities Primary responsibilities 1. Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects. 2. Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3. Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1. Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2. Review of clinical and non-clinical overviews and summaries of CTD 3. Review of medical rationale for CT waiver applications 4. New products evaluation for development 5. Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6. Mentoring/ training team members to gain required skills to enable on-time deliverables. Required Educational Qualification: MBBS and/or MD (Pharmacology) Work Exp.: MBBS with 10-12 years of experience [OR] MD (Pharmacology) 8-10 years of experience Mandatory Skills Required: Clinical Trails, Protocol Writing, Medical Writing, Investigatioons

Job description 1 Medical to Medical connect with HCPs in the MDR Bacterial Infection Therapy Area 2 Developing regional KOLs. (these are office bearers of district chapters of various medical associations, regional speakers / trend setter at district level, KOLs attached to medical schools). 3 Conducting regional CMEs (from content development to conducting local CMEs). 4 Periodic scientific discussion, journal clubs, latest literature / articles with regional KOLs along with our field force. 5 Support in execution of various product surveillances, epidemiological studies etc 6 Handling product complaints by personally meeting and understanding the case, literature support and helping Dr to find out the reason. 7 Support to KOLs in medical research or Investigator Initiated Studies (IIS). Qualification : MBBS (Fresher)

Role & responsibilities Policy Development Facilitation: Draft, refine, and finalize medical policy documents. Collaborate with scientific literature researchers to incorporate comprehensive scientific evidence into policy drafts. Facilitate working sessions to refine and clarify policy drafts. Provide feedback and guidance to ensure alignment with organizational goals and standards. Medical Policy Updates and Maintenance: Ensure medical policy definitions are current and accurately reflect the latest medical guidelines. Regularly review and update medical policies to incorporate the latest scientific evidence and clinical best practices. Handle internal requests, scheduled reviews, and updates. Ensure policies are compliant with CMS policies such as NCDs and LCDs. Stakeholder Engagement and Communication: Foster strong relationships with key internal stakeholders, including policy writers, medical directors, and clinical leadership. Communicate policy changes and updates effectively to all relevant internal parties. Quality Assurance and Review: Conduct quality checks on policy documents before final approval and publication. Ensure consistency and accuracy in all policy documents. Implement a robust review process involving internal and external experts to validate policy content. Training and Development: Develop and deliver training sessions for policy writers on best practices and organizational standards. Provide ongoing support and mentorship to policy writers to enhance their skills and knowledge. Documentation and Process Management: Maintain comprehensive documentation of policy development processes and procedures. Develop and manage a repository for policy documents and related resources. Ensure all documentation is up-to-date and accessible to relevant stakeholders. Post approved policies in Confluence. Performance Monitoring and Reporting: Track and report on the progress of policy development projects. Provide regular updates to senior management on policy status, challenges, and achievements. Utilize data and metrics to assess the effectiveness of policies and identify areas for improvement. Your background & requirements: Required Experience: Preferred: Bachelors in nursing or advanced degree such as a Master of Science in Nursing, Master of Physician Assistant Studies, or Masters degree in Public Health, Health Science, Healthcare Administration, etc. 3-5 years of experience in medical writing, policy development, or scientific literature research and vetting. Familiarity with CMS policies such as NCDs and LCDs. Strong organizational and project management skills. Excellent communication skills, both written and verbal. Ability to manage multiple projects with competing priorities. Detail-oriented and enjoy managing simultaneous projects with multiple stakeholders. Ability to work well both as part of a team and independently. Ability to work independently in a remote work environment with minimal supervision. Proficient in using collaboration tools such as Confluence and project management software. Utilization review experience is a plus Preferred candidate profile - Life science graduate experienced for minimum of 3 yrs on NCD, CMS, LCD are mostly preferred.

Job Title: Medical Communication Specialist Career Level: D Introduction to role: Are you ready to apply your scientific expertise to build compelling medical content and communication? Join our team and support the delivery of life-changing medicines for patients by enabling the rest of the business to run optimally. Were on a journey of growth and evolution, finding innovative ways to translate value for the business and our patients. Accountabilities: Apply scientific knowledge and insights relevant to therapeutic areas, healthcare systems, products, disease state management, emerging therapies, and the competitive landscape, integrated with knowledge of the regulatory environment, to create compelling medical content and communication. Work together with Medical Information and Communications (MI&C) staff and key collaborators to implement scientific content strategy and build and share scientific content to fulfill customer needs. Support HCPs through delivery of high-quality, timely, customer-focused medical information. Contribute to MI&C processes to drive operational excellence, efficiency, and digital innovation. Scientific Content: Develop, review and maintain scientific communication materials (scientific narratives and foundations [platform], digital assets, Field Medical materials, and other medical materials) in collaboration with MI&C team and Medical Affairs. Translate published literature and emerging science into digestible formats for healthcare professionals (HCPs) and key internal collaborators. Perform literature searches to support content strategy. Advanced inquiries that are raised to Global MI&C team from local markets. Essential Skills/Experience: Advanced scientific degree (PharmD preferred, MD, PhD, or equivalent) Minimum of 3-5 years of experience in scientific communications or related roles within the pharmaceutical, biotechnology, or healthcare industry Skills/Capabilities: Clinical and healthcare systems expertise Scientific literature evaluation and analysis Excellent written and verbal communication skills with the ability to distill complex scientific information into clear and compelling messages for diverse audiences Scientific/medical writing, communication, and content creation (e.g., slide decks) Strong verbal and written communication skills Strategic problem solver with strong discernment, project management, and organizational skills Proficiency in applying technology/platforms Experience developing digital content and/or digital content strategy highly desired Experience in mentoring and coaching team members (for Manager position) Ability to apply local regulatory, legal, and compliance requirements to Medical Affairs activities and drug information deliver

Job title : Sr. Associate - HEVA (Evidence Synthesis) Hiring Manager: Head/Group Lead/Research Lead/Team Lead HEVA Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About the job Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions . MedHub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally. Main responsibilities: The overall purpose and main responsibilities are listed below: Support HEVA team in assigned therapy area portfolio to plan and generate robust health economics and value based evidence to maximize the value propositions from both a global and US perspective working within the Market Access tripod Support the execution of quality research projects, economic models, trial design recommendations and other activities in support of programs/products Seek opportunities to innovate HEVA value identification, evidence generation and dissemination process/plan to increase the relevance and impact of HEVA evidence to ensure reimbursement decisions optimal access Develop and maintain TA expertise People: (1) Support and maintain effective relationships with key stakeholders (2) Work effectively with global HEVA teams across various time zones Performance: (1) Support in the HEVA evidence generation plan: Develop research plan for pre-launch, launch and post-launch evidence for investigational and marketed drugs; Evidence generation plan includes burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective, and prospective observational studies, economic evaluations, development and analysis of patient-reported outcomes; Provide strategic support with individuals and institutions, which may serve as resources for evidence generation purpose, etc. (2) Support execution of approved HEVA study(s) and manage ongoing study(s) if required: Supports the manager/HEVA product lead to manage and execute research studies to support the clinical, economic and humanistic value of products; Studies include but are not limited to burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes (3) Support development of core value dossier (CVD) and AMCP dossiers and provide strategic direction Process: (1) Assist HEVA team in development of HEVA strategic evidence material (2) Assist manager in development of core HEVA strategic evidence generation processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with CVD, the US AMCP dossier, and HEVA contributions as appropriate to other submissions (3) Maintain adherence to the evidence generation guidelines and other standards relevant to HEVA evidence generation processes Stakeholder: (1) Work with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs and Market Access global or local teams in regions/areas to identify evidence generation and dissemination needs and assist in developing assigned deliverables (2) Support HEVA team to prepare relevant & customized deliverables for these Teams About you Experience : 5 + years of experience in HEOR for the pharmaceuticals industry, CRO consultancy or academia. Soft and technical skills : Stakeholder management; writing/communication skills; external engagement and ability to work independently and within a team environment Strong analytical skills to translate clinical and economic information and messages into payer evidence strategies; Understands reimbursement decisions to determine value drivers and how evidence is used in decision making and how it impacts various payers (e.g., providers, patients, health systems); Knowledge of methods and principles of health economics, health technology assessment (HTA) reviews Education : Advanced degree in life sciences/pharmacy/similar discipline or medical degree Languages : Excellent knowledge of English language (spoken and written) Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Join an international biopharma company.

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

The Associate Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC d data packages including tables, figures, and listings for use in publications (ie abstracts, posters, oral, presentations, manuscripts, and ad-hoc data analysis requests) ; The Associate Statistical Programmer will assist in developing, implementing of programming techniques. The Associate Statistical Programmer will ensure SOPs are followe'd and that timelines and quality standards are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages eg SAS. 3) Produce we'll documented data packages that include tables, listings, and figures. 4) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables. About you Experience : B.Sc. or Masters degree minimum 1 years of relevant experience required, or a minimum of 6 months of relevant internship experience. Soft skills : Ability to manage timelines and Ability to work independently and within a team environment. Technical skills : Base SAS programming skills, basic knowledge SDTM & ADaM (CDISC) Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge - written and spoken

QC and formatting of clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), investigator’s brochures (IBs), and clinical data summaries for phase 1-phase 3 and post-marketing surveillance studies and as per agreed timelines. QC and formatting of clinical modules of eCTD dossiers for global approval in developed and emerging markets with high quality and as per agreed timelines. Ad-hoc writing support for clinical documents such a ICFs, CSRs and protocols CSR publishing for regulatory submissions. Ad hoc QC and formatting support for cross-functional teams in Medical Affairs and Clinical Development Support in creating and/or updating SOPs, checklists, and templates. Work collaboratively with other medical writers and cross-functional stakeholders within the Clinical Development function. Support Group Lead in maintaining and tracking medical writer occupancy and resourcing Qualification M Pharm with minimum 5 years of experience in document QC and formatting within the pharmaceutical industry Excellent written, spoken, interpersonal and presentation skills Proficiency in editing and formatting documents using Microsoft Office and Acrobat. Good understanding of medical terms, clinical trials, and drug development process. Ability to analyze and interpret scientific and medical data Highly detailed orientated and excellent time management skills Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Skills Required : Medical background, Medical affairs, Regulatory knowledge, Strong understanding of corporate business domain of Pharma Education/Qualification : MBBS, MD - Pharmacology (added advantage

Overview Cactus Life Sciences partners with the global biopharma industry to drive innovation and elevate patient outcomes through agile, science-driven medical communications. We transform complex data into actionable insights, bridging the critical gaps between research, decision-making, and real-world healthcare impact. As a growing scientific communications agency, we are seeking a self-motivated, strategy-oriented Medical Director to add to our scientific services team. Please note: While we are a remote-first organization, this role is specifically for candidates located on the East Coast of the US. Responsibilities Work with clients Medical Affairs and Scientific Communications teams to develop and execute strategic scientific communications initiatives such as scientific communications platforms, scientific communications plans, KOL engagement plans, etc. Work with clients scientific teams to develop and execute both publications and medical communication tactics, such as manuscripts, abstracts, posters, review articles, symposia decks, literature searches, gap analyses, strategic publication plans, and MSL field materials. Take ownership of client relationship by partnering with the Account Director to build confidence in company's service offerings ensure compliance and consistency with client SOPs, messaging, and scientific communications objectives and assisting with resolution of client concerns. Work with in-house technology and creative teams to build innovative digital solutions for Medical Affairs and Scientific Communications clients. Oversee and be accountable for quality of scientific communications tactics/deliverables developed by in-house scientific writers. Review deliverables to ensure strategic alignment and scientific accuracy and be accountable for quality of deliverables sent to the client. Develop, manage, and track strategy and tactics in partnership with a cross-functional team of internal and client stakeholders. Train and mentor junior writers contribute to skill development of the writing team. Participate in client pitches and business development meetings as the scientific lead. Ensure organic growth through ensuring quality deliverables and client engagement. #LI-Remote Qualifications and Prerequisites MD, PhD, PharmD or similar advanced degree required. At least 5 years of core writing experience and 3+ years of experience as a Medical Director at a pharmaceutical company or 7+ years of core writing experience and 2+ years as an Associate Medical Director. Integrated Scientific Communications experience preferred with demonstrated experience on both medical communications and publications accounts. Demonstrated expertise in developing and executing deliverables mentioned in the above for both investigational and mature products. Experience across several therapy areas preferred. Experience in writing/reviewing deliverables. Experience with developing digital content and other deliverables to supplement traditional deliverables and communications. Strong attention to detail and editorial skills needed. Willingness to train and develop junior writers by doing detailed reviews of documents and training sessions. Experience providing congress support and conducting/facilitating advisory board meetings a plus. This role is fully remote (based anywhere in the US) travel to client locations, meetings, etc within the US and elsewhere will be required. Must work East Coast times. Application Process Before applying, please ensure you meet the role requirements listed above and have legal authorization to work in the country where this role is advertised. The selection process for this role includes an initial recruiter screening, an interview with the hiring manager, a proctored strategic assessment, and two additional interview rounds. Equal Opportunity Our hiring practices reflect our commitment to providing equal opportunities and creating an environment where everyone can thrive, develop, and succeed.We celebrate the uniqueness of our team members and prohibit discrimination of any kind, based on race, color, religion, gender identity, sexual orientation, age, marital status, disability, or any other protected characteristic. Accelerating from Anywhere As a remote-first organization, these are essential attributes we look for in all our candidates. Taking ownership of your work with minimal supervision, showing strong ability to organize, prioritize and deliver results independently. Documenting work that brings everyone on the same page. Maturity to choose between synchronous and asynchronous collaboration. Effectively collaborating with colleagues across different time zones by setting dedicated hours for collaboration and keeping team members updated through your MS Teams status. About CACTUS At Cactus Life Sciences (cactuslifesciences.com), we believe the future of medical communications lies at the intersection of science, technology, and human connection. Headquartered in Princeton, New Jersey, with teams in Switzerland, the United Kingdom, India, and Japan, we help biopharmaceutical organizations redefine scientific exchange - leveraging AI, automation, and innovation while keeping patients at the heart of everything we do. Our expertise spans medical strategy, scientific content development, and medical education across therapeutic areas and the product lifecycle. By blending scientific rigor, agile operational models, and future-ready technologies, we partner with medical affairs teams to catalyze their transformation, adapt to a changing landscape, and drive meaningful outcomes for healthcare communities worldwide.

Summary -Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products life cycle. Provides safety support to the clinical development teams. About the Role Major accountabilities: Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately . Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees. Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products. Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. Contributes to the development of departmental goals and objectives. Distribution of marketing samples (where applicable) Key performance indicators: Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables Minimum Requirements: Work Experience: People Challenges. Critical Negotiations. People Leadership. Collaborating across boundaries. Operations Management and Execution. Skills: Clinical Trials. Functional Teams. Literature Review. Management Skills. Medical Information. Medical Records. Medical Strategy. Pharmacovigilance. Regulatory Compliance. Risk Management. Safety Science. Languages : English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Medical Affairs Group Job Sub Function: Professional Medical Education Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India, Mumbai, India Job Description: Implements modifications to education and training programs that address educational gaps among medical professionals and support the sales team in achieving and exceeding product sales goals and departmental objectives. Implements processes to integrate cutting-edge digital technologies and content delivery methods that improve product understanding, enable sales, and enhance the overall medical professional customer experience. Applies in-depth knowledge of professional medical education practices to inform the improvement of education plans, training programs, and content delivery methods that support corporate marketing and branding strategies. Identifies opportunities to influence product sales by facilitating product demonstrations and promoting company technologies at professional medical conferences, organization-sponsored symposia, and healthcare provider seminars. Serves as an induvial contributor and developing specialist on professional education programs and offers feedback regarding the sustainability of medical education initiatives, innovative learning systems, and relevant regulatory requirements. Facilitates the implementation of key performance indicators that monitor, track, and evaluate the effectiveness of education plan improvements and training program modifications. Coaches more junior colleagues in techniques, processes and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team. Role Overview This position is responsible for creation and execution of one DePuy Synthes -Joint recon Business professional education (ProfEd) strategy for the Hip Portfolio in India for Health Care Professionals; including development of learning continuums, designing customized hybrid modes of education to enable access, forging external partnerships, and deploying new technologies and learning strategies that will guarantee the flawless deployment of the medical education strategies & concepts developed in collaboration with the regional team and DePuy Synthes Business teams. collaborating with the region to develop an ANA (Agreed upon Necessary Action) for A deep understanding of the clinical educational environment across India and regions to understand Professional Education strategy and execute on a portfolio of offerings / courses that will advance patient outcomes. Course Development Design and create customized Professional Education courses for the Joint Reconstruction - Hip business in collaboration with Key Opinion Leaders (KOLs) and the Business Unit (BU). Digital Education Integration Ensure the effective use of digital education tools by creating and implementing courses that efficiently educate healthcare professionals. This will include utilizing virtual reality (VR), online platforms, and tools such as Jji.com and Proximie to enhance the learning experience for HCPs. Education Strategy Development Develop an Education Strategy for new product introductions (NPIs) that are in the pipeline, aimed at training surgeons on the safe and effective use of Hip NPIs. Design & develop customized Professional Education courses for Joint recon - Hip business in collaboration with KOLs, BU Ensuring seamless utilization of digital education tools and creating and implementing courses to efficiently educate healthcare professionals. This includes the use of virtual reality (VR), online tools, and Jji.com , Proximie to enhance the learning experience Develop an Education Strategy on -NPIs which will be lot in the Pipeline - Making a strategy to train the surgeons on safe and effective use of - Hip NPIs Requirement Professional Education Implementation Develop and implement professional education strategies aimed at engaging HCPs regarding the safe and effective use of DePuy Synthes Hip products. Faculty Development Identify, onboard, and train faculty members to support the development of our Professional Education Program, including the creation of internal and external communications. Collaboration Foster strong partnerships with internal teams and external stakeholders to assess and implement innovative training technologies and models that align with our Professional Education objectives. Contract Management Manage contracts with key education suppliers to ensure quality and compliance. Event Logistics Oversee the logistical management of educational events conducted by the Joint Recon - Hip Portfolio Marketing /Sales team. Regulatory Compliance Ensure compliance with applicable statutory regulations and medical associations in the respective countries. Innovative Programs Support Professional Education initiatives by developing innovative programs and channels tailored to Hip Joint Reconstruction in different countries. Hands-On Training JNJ Institute Academy Create a JNJ Institute Academy focused on Hip programs to ensure safe use of effective training for HCPs. Course Development Formulate operating guidelines, design course brochures, and develop appropriate training materials. Academic Partnerships Work collaboratively with medical colleges, academic institutions, and medical associations to drive Professional Education programs of Hip Portfolio Technical Support Provide technical assistance to Sales and Marketing teams, ensuring they have the necessary tools and information. Collaboration ; Work closely with Cadaver Labs, simulation labs, government institutes, and private institutions to conduct hands-on training sessions for delegates across India and the ASPAC region." Performance Dashboard Manage the Professional Education dashboard across franchises to monitor and report on progress. Cross-Regional Collaboration Collaborate closely with professional education partners across APAC, US, EMEA, Latin America, etc., to enhance HCP knowledge exchange programs. Centre of Excellence Development Develop a Centre of Excellence in Hips aimed at training a broader pool of surgeons on product knowledge and procedural learning. Guidelines Compliance :Incorporate the new guidelines (UCPMPMD) into the design and implementation of Hip programs, ensuring compliance with local government regulations. Adhering to these requirements is a key and mandatory aspect of our educational initiatives.