Senior Medical Regulatory Writer

5+ years

Not Disclosed

Hyderabad

10 Feb. 6, 2025

Job Description

Job Type: Full Time Education: PhD/D Pharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here's the rewritten job description with a unique slug:

Senior Medical Regulatory Writer | Hyderabad, India | Permanent | Sanofi

Posted on: Nov. 07, 2024
Closing on: Feb. 28, 2025

About the Job:

Sanofi Global Hub is seeking a Senior Medical Regulatory Writer to join their team. This role involves writing and editing high-quality safety and clinical documents, including Clinical Study Reports (CSRs), Periodic Benefit-Risk Evaluation Reports (PBRER), Disease and product ID cards, and clinical evaluation reports. The Senior Medical Regulatory Writer will work independently with minimal supervision and mentor junior writers, ensuring timely and compliant delivery of medical documents.

Key Responsibilities:

Document Writing & Editing: Write and edit medical regulatory documents such as PBRERs, CSRs, trial transparency documents, and product alerts, adhering to internal and external standards.
Collaboration: Work with Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Regulatory, and Corporate Affairs teams to develop and review documents.
TA Expertise: Develop and maintain expertise in the assigned therapeutic area (TA).
Stakeholder Relationships: Build and maintain effective relationships with stakeholders within the medical scientific community and cross-functional teams.
Mentorship: Assist and mentor junior medical writers, sharing knowledge and best practices.
Deliverables: Ensure timely submission of deliverables such as briefing packages, product alerts, and clinical trial information.
Regulatory Compliance: Maintain an understanding of regulatory requirements, assisting in medical regulatory writing needs analysis, and ensuring audit readiness.

About You:

Experience: Over 5 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
Soft Skills: Strong stakeholder management, communication skills, and the ability to work independently and in a team environment.
Technical Skills: Proficiency in medical editing and writing, data retrieval, scientific data interpretation, and medical literature screening. Familiarity with ICH, GCP/GVP guidelines.
Education: Advanced degree in life sciences, pharmacy, or a similar discipline (PhD, Master’s, PharmD, or MBBS).
Languages: Excellent command of the English language (written and spoken).

What We Offer:

At Sanofi, we value diversity and provide equal opportunities to all individuals, ensuring a welcoming environment for all employees.

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Senior Medical Regulatory Writer

Job Description

Senior Medical Regulatory Writer | Hyderabad, India | Permanent | Sanofi

About the Job:

Key Responsibilities:

About You:

What We Offer:

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