Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Senior Medical Regulatory Writer
Job Description
• People : 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.
2) Interact effectively with stakeholders in medical and pharmacovigilance departments.
3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
• Performance: Provide deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA) as per agreed timelines and quality
• Process : 1) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
4) Work with selected vendors within the region to deliver the required deliverables as per the defined process.
5) Design an overall plan of action basis end-customers feedback & improve course content and delivery.
• Stakeholders:
1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
2) Liaise with the Medical department to prepare relevant & customized deliverables.
Candidate Profile
• Experience : >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
• Soft skills : Stakeholder management; communication skills; and ability to work independently and within a team environment
• Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills)
• Education : Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D. – master’s in science)
• Languages : Excellent knowledge of the English language (spoken and written)
Additional Information
Experience : >5 years of experience
Qualification : Advanced degree in life sciences/ pharmacy
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 31st August, 2023
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