Expert Medical Regulatory Writer Job – Sanofi, India
Join Sanofi, a global leader in the pharmaceutical industry, as an Expert Medical Regulatory Writer, driving high-quality regulatory writing for clinical submissions. Collaborate with cross-functional teams and contribute to life-changing healthcare innovations while showcasing your expertise in CTD submissions, clinical study reports, and stakeholder management.
About the Company
Sanofi, a global leader in the pharmaceutical industry, is seeking an Expert Medical Regulatory Writer to produce high-quality clinical and safety documents for regulatory submissions. The role involves preparing complex CTD submission documents such as clinical overviews (CO), summaries of clinical efficacy (SCE) and safety (SCS), risk management plans (RMP), and periodic benefit-risk evaluation reports (PBRER).
Job Posting: Expert Medical Regulatory Writer
Responsibilities of Expert Medical Regulatory Writer:
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Write and/or edit high-quality clinical and safety documents under guidance for submission to regulatory authorities to support:
- Marketing authorization applications
- Renewals and maintenance activities
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Create complex regulatory documents, including:
- Clinical Study Reports (CSR)
- CTD submission documents, including:
- Clinical overview (CO)
- Summary of clinical efficacy (SCE)
- Clinical safety (SCS)
- Clinical pharmacology (SCP)
- Biopharmaceutics (SBP)
- Medical section of Periodic Benefit-Risk Evaluation Report (PBRER)
- Medical sections of Addendum to Clinical Overview (ACO)
- Risk Management Plans (RMP)
- Product and Disease ID Cards
- Clinical evaluation reports
- Briefing packages
- Responses to Health Authorities Queries
- Immunogenicity reports
- Product alerts
- Trial transparency documents
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Deliver high-quality medical documents on time, ensuring compliance with both internal and external standards and guidelines.
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Work independently on documents, serving as:
- A Subject Matter Expert (SME) on clinical deliverables
- A buddy or mentor to medical and senior medical writers
- An efficient peer reviewer, providing scientific input and feedback.
Essential Job Duties and Responsibilities
- Leading complex submissions, contributing to key messaging meetings, providing expert content guidance for medical sections of CTD, and delivery of high-quality medical documents in time and in compliance with internal standards and external guidelines.
- Participate in the planning of analysis and data presentation to be used as an ad-hoc member of the Clinical Trial Team (CTT), a core member of the Clinical Submission Teams (CST), and an extended member of the Global Clinical teams (GCT) and Safety management team (SMT).
- Develops and maintains TA expertise and provides document-related advocacy to other line functions.
- Reviews content created by peer writers and act as a coach, mentor, and trainer for the development of writers for the new document type.
- Work with minimal supervision and support development of medical regulatory writers.
- Agile and knowledgeable to be able to work across therapeutic areas.
Collaboration
Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, CTT, CST, GCT, and SMT.
About You
Experience: ≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment, leading project teams
Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management; Expert knowledge of and demonstrated accomplishment in global registration of drugs)
Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters, or bachelor’s in science, D Pharma, Pharm D) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
Languages: Excellent knowledge of the English language (to read, write and speak)
Keywords: Expert Medical Regulatory Writer, Pharmaceutical Industry, Healthcare, Regulatory Writing, Clinical Study Reports, CTD Submission, Stakeholder Management, Project Management.
