Job Title: Senior Medical Regulatory Writer
Location: India (Sanofi Global Hub)
About the Job
Join the Sanofi Global Hub, a central resource organization based in India that supports a wide range of Sanofi's functions including Specialty Care, Vaccines, General Medicines, Consumer Healthcare, Clinical Operations, and Research & Development. As part of our team, you'll work on high-impact regulatory submissions and contribute to the advancement of healthcare globally.
In this role, you will lead the development of complex clinical and safety documents, mentor other writers, and collaborate with cross-functional teams to deliver high-quality medical regulatory content.
Main Responsibilities
Document Development
Write and edit high-quality clinical and safety documents, including Clinical Study Reports (CSR), Common Technical Document (CTD) modules, Periodic Benefit-Risk Evaluation Reports (PBRER), Risk Management Plans (RMP), and other regulatory documents.
Develop medical sections of briefing packages, responses to Health Authority Queries (HAQs), and trial transparency documents.
Deliver documents on time while ensuring compliance with internal and external standards and guidelines.
Leadership and Expertise
Lead complex submissions, contribute to key messaging meetings, and provide expert content guidance for regulatory submissions.
Act as a Subject Matter Expert (SME) for medical documents and mentor junior and senior writers.
Plan analysis and data presentation in collaboration with the Clinical Trial Team (CTT) and Clinical Submission Teams (CST).
Cross-functional Collaboration
Collaborate with global and local teams in Scientific Communication, Pharmacovigilance, and Clinical Operations.
Interact with cross-functional teams (CTT, CST, GCT, and SMT) to align document requirements with stakeholder needs.
Therapeutic Area Expertise
Develop and maintain expertise in therapeutic areas to provide advocacy and guidance.
Coach and train team members on new document types and regulatory processes.
Stakeholder Engagement
Build effective relationships with medical, pharmacovigilance, and regulatory stakeholders.
Serve as a liaison to align deliverables with stakeholder expectations.
About You
Experience
At least 8 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
Proven ability to lead regulatory submissions and manage complex projects.
Technical Skills
Expertise in writing clinical and safety documents for regulatory submissions.
Familiarity with therapeutic areas, publication submissions, and project management.
Advanced understanding of global drug registration processes.
Soft Skills
Strong stakeholder management and communication skills.
Ability to work independently and as part of a team.
Mentoring and coaching capabilities.
Education
Advanced degree in life sciences, pharmacy, or a similar discipline (PhD, Master's, or Bachelor's in Science, D Pharma, or Pharm D).
Medical degrees such as MBBS, BDS, BAMS, BHMS, or MD are also suitable.
Languages
Fluency in English (written and verbal) with the ability to produce high-quality documents.
Why Join Us?
Career Development: Opportunities to lead critical submissions and grow as a mentor and SME in regulatory writing.
Collaborative Environment: Work with global teams to drive meaningful healthcare advancements.
Diversity & Inclusion: Be part of an organization that values diversity and fosters inclusivity.
Comprehensive Benefits: Competitive rewards, wellness programs, and career mobility opportunities.
Our Commitment
At Sanofi, we aim to empower people from diverse backgrounds to contribute to healthcare innovation. We provide equal opportunities and encourage growth, collaboration, and inclusivity.
Learn more about our Diversity Equity and Inclusion initiatives at sanofi.com.
Apply Now
Take your career to the next level by joining a team dedicated to delivering extraordinary results. Let’s pursue progress together!
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