Great opportunity to work as Senior Medical Regulatory Writer at Sanofi

About Sanofi

Sanofi’s commitment to preventing illness through vaccines and providing innovative treatments is crucial for improving public health and well-being. With a presence in numerous countries and a diverse team of over 100,000 individuals, Sanofi is well-positioned to contribute to scientific innovation and deliver healthcare solutions worldwide.

Post: Senior Medical Regulatory Writer

Job Description:

People:

• Build and Maintain Relationships: Cultivate strong connections with key stakeholders within the allocated Global business unit and product to create medical regulatory content aligned with requirements.
• Collaboration: Engage effectively with medical and pharmacovigilance teams, fostering collaboration for successful outcomes.
• Knowledge Sharing: Support fellow medical regulatory writers, contributing expertise and promoting knowledge sharing.

Performance:

• Timely Deliverables: Generate essential materials (PBRER, ACO, CSR, ID Cards, Investigator brochure, etc.) within agreed timelines and uphold quality standards.

Process:

• Regulatory Expertise: Assume a leadership role in medical regulatory writing, ensuring compliance with diverse country regulations.
• Needs Analysis: Aid the medical team in a comprehensive assessment of medical regulatory writing requirements.
• Implementation: Execute identified elements of the medical regulatory plan for the region, coordinating with vendors as necessary.
• Continuous Improvement: Develop action plans based on customer feedback, enhancing content and delivery.

Stakeholders:

• Collaborative Planning: Work closely with regional medical teams to identify and fulfill medical writing needs.
• Customized Deliverables: Liaise with the Medical department to create tailored, pertinent materials.

Candidate Profile:

• Experience: Over 5 years of regulatory writing experience in the pharmaceutical/healthcare sector.
• Soft Skills: Proficient in stakeholder management, communication, and adept at both independent and team-oriented work.
• Technical Skills: Demonstrates Medical operational excellence, time and risk management proficiency, and exceptional technical (medical) editing and writing abilities.
• Education: Advanced degree in life sciences/pharmacy or similar discipline, or a medical degree (Ph.D. or master’s in science).
• Languages: Exceptional command of spoken and written English.

Additional Information:

• Experience: Over 5 years of experience.
• Qualification: Advanced degree in life sciences/pharmacy.
• Location: Hyderabad.
• Industry Type: Pharma / Healthcare / Clinical research.
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