Senior Medical Regulatory Writer

5+ years

Not Disclosed

Hyderabad

10 Dec. 3, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/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

Job Title: Medical Regulatory Writer
Location: India (Sanofi Global Hub)

About the Job

Join Sanofi Global Hub, a centralized organization that supports Sanofi’s global operations across Specialty Care, Vaccines, General Medicines, Consumer Healthcare, Research & Development, and more. This is a critical role for delivering high-quality medical and regulatory documentation that supports global clinical and safety efforts.

Main Responsibilities

Document Development

Write and edit high-quality clinical and safety documents, including:
- Clinical Study Reports (CSRs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Addendum to Clinical Overviews (ACO)
- Product and Disease ID Cards
- Clinical Evaluation Reports
- Product Alerts and trial transparency documents
Deliver documents on time, ensuring compliance with global and regional regulatory standards.

Collaboration and Teamwork

Work effectively with cross-functional teams, including:
- Global/local scientific communication teams
- Pharmacovigilance, regulatory, and corporate affairs teams
- Clinical/medical teams across regions
Participate in planning data presentation and contribute to key deliverables.

Expertise and Mentorship

Develop and maintain expertise in therapeutic areas and regulatory guidelines.
Mentor and peer-review content developed by junior writers.
Act as a Subject Matter Expert (SME) for medical and regulatory writing needs.

Stakeholder Engagement

Maintain strong relationships with medical and pharmacovigilance departments to ensure deliverables meet stakeholder requirements.
Proactively identify medical writing needs and provide tailored solutions.

Operational Excellence

Track document postings, manage audit readiness, and maintain system archives.
Author or review standby statements and Q&A documents for Product Alerts.
Stay updated on Sanofi policies and global regulatory requirements.

About You

Experience

5+ years of experience in regulatory writing for the pharmaceutical or healthcare industry.

Technical Skills

Proficiency in medical editing, scientific data interpretation, and summarizing complex information for diverse audiences.
Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP).
Advanced skills in computer applications and document management tools.

Soft Skills

Excellent communication and stakeholder management abilities.
Ability to manage vendors and work independently or in team environments.

Education

Advanced degree in life sciences, pharmacy, or similar disciplines (PhD, Master’s, Bachelor’s in Science, D Pharma, PharmD).
Medical degrees such as MBBS, BDS, BAMS, BHMS, or MD are also suitable.

Languages

Fluency in English (written and verbal) for producing high-quality documentation.

Why Join Us?

Meaningful Work: Be a part of a global team contributing to advancements in healthcare.
Growth Opportunities: Opportunities to develop as an SME, mentor peers, and lead critical projects.
Diversity & Inclusion: Sanofi is committed to creating an inclusive workplace that values diversity.
Comprehensive Benefits: Competitive rewards, wellness programs, and career mobility.

Our Commitment

At Sanofi, we value people from all backgrounds, united by a shared mission to drive progress in healthcare. We are dedicated to building a workplace where everyone can thrive.

Apply Now
Take your career to the next level by contributing to extraordinary outcomes in healthcare. Let’s pursue progress together!

Learn more about our Diversity Equity and Inclusion initiatives at sanofi.com.

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