Job Title: Senior Medical Regulatory Writer
Location: Hyderabad, India
Job Type: Permanent
Posted: Nov. 07, 2024
Expires: Apr. 30, 2025
About the Job
Our Team:
Sanofi Global Hub, located in India, is an internal resource organization set up to centralize processes supporting various functions like Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital. Sanofi Global Hub strives to be a strategic partner for tactical deliveries to global teams within Sanofi.
Main Responsibilities:
Write and edit high-quality clinical and safety documents, including Periodic Benefit-Risk Evaluation Reports (PBRER), Clinical Study Reports (CSR), product alerts, trial transparency documents, and more.
Ensure timely delivery of documents in compliance with internal and external guidelines.
Work independently on assigned documents and mentor/peer review the work of medical writers.
Collaborate with global teams, including Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Regulatory Affairs, and Corporate Affairs.
Key Duties:
Participate in data analysis and presentation planning alongside mentoring writers.
Maintain therapeutic area (TA) expertise.
Review content created by peer writers.
Collaborate with cross-functional teams to develop regulatory content.
Track and manage product alerts, trial information, and ensure audit readiness.
Stakeholder Management:
Build relationships with stakeholders in the medical scientific community.
Liaise with Clinical/Medical teams and proactively engage with other departments such as Pharmacovigilance, Biostats, and Legal to create customized deliverables.
Performance:
Deliver high-quality medical regulatory documents (PBRER, CSR, etc.) according to agreed timelines.
Ensure compliance with regulatory requirements and assist in the development of medical regulatory writing plans.
Prepare and review materials, including Product Alerts and medical sections of clinical trial applications.
About You
Experience:
5+ years of experience in regulatory writing within the pharmaceutical/healthcare industry.
Soft Skills:
Stakeholder management, communication, vendor management, and ability to work independently or in a team.
Technical Skills:
Expertise in medical writing and editing, knowledge of ICH and GCP/GVP guidelines, data interpretation, and regulatory compliance.
Familiarity with medical literature screening, data retrieval, and the ability to summarize scientific information for various audiences.
Education:
Advanced degree in life sciences, pharmacy, or a similar discipline (PhD, Master’s, or Bachelor's) or medical degree (MBBS, BDS, MD).
Languages:
Proficiency in English (both written and spoken).
Why Sanofi?
At Sanofi, we strive to make the impossible possible. We provide opportunities for people from diverse backgrounds, ensuring equal opportunities for all. We aim to create a diverse, equitable, and inclusive environment where everyone can progress. Join us to be part of a company that is driving global healthcare transformation.
Commitment to Equality: We believe in equal opportunities regardless of race, color, gender, sexual orientation, age, disability, or any other characteristic.
For more details about our recruitment process and other opportunities, feel free to explore our job openings and submit your application.
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