Sanofi Hiring Medical Regulatory Writer

Sanofi Business Operations is a strategic organization that supports various global business units, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. The division focuses on providing centralized services to enhance Medical, HEVA, and Commercial operations globally.

Main Responsibilities:

The Medical Regulatory Writer will be responsible for authoring and editing high-quality safety and medical documents, ensuring timely delivery in compliance with internal and external standards and guidelines.

Key Deliverables:

• Write and edit:
  • Medical sections of Periodic Benefit-Risk Evaluation Reports (PBRER).
  • Addendum to clinical overview documents.
  • Disease and Product ID Cards.
  • Product alerts and trial transparency documents.
• Deliver high-quality, compliant medical regulatory content.

Essential Duties:

1. Document Planning and Analysis:
   • Participate in planning data analyses and presentations, under guidance.
   • Develop expertise in Therapeutic Areas (TA).
2. Collaboration:
   • Work with Scientific Communication teams, Medical Regulatory Writing teams, Pharmacovigilance teams, and Regulatory Affairs.
3. Stakeholder Interaction:
   • Build effective relationships with stakeholders within the allocated business unit and product area.
   • Interact with medical, pharmacovigilance, and regulatory departments to develop required content.
4. Content Development:
   • Author, review, and maintain regulatory documents, including PBRERs, Addendums, ID Cards, and Product Alerts.
   • Manage postings on platforms like CTG, EUCTR, and EUDRACT.
   • Track postings and ensure audit-readiness.
5. Process Implementation:
   • Support comprehensive regulatory writing needs analysis.
   • Implement elements of the annual medical regulatory plan.
   • Ensure compliance with Sanofi policies and quality standards.

Skills and Qualifications:

Experience:

• Over 2 years of experience in regulatory writing within the pharmaceuticals or healthcare industry.

Technical Skills:

• Expertise in medical writing, editing, and summarizing scientific information.
• Knowledge of ICH guidelines, GCP/GVP, and regulatory requirements.
• Proficiency in data retrieval, scientific data interpretation, and medical literature screening.
• Advanced computer application skills.

Soft Skills:

• Strong stakeholder and vendor management.
• Excellent communication skills.
• Ability to work independently and as part of a team.

Education:

• Advanced degree in Life Sciences, Pharmacy, or related disciplines (PhD, Master’s, or Bachelor’s in Science, D Pharma, PharmD).
• Medical degrees such as MBBS, BDS, BAMS, BHMS, or MD are also eligible.

Language Requirements:

• Proficient in English (reading, writing, and speaking).

Application Link