Medical Regulatory Writer Job at Sanofi For Life Sciences, Apply Online
Job Title – Senior Medical Regulatory Writer
Location – Hyderabad
About the job
Write and/or edit high-quality clinical and safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports (CSR), ID Cards, and evaluation reports, with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards.
Essential Job duties and responsibilities:
- Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
- Develops and maintains TA expertise.
- Reviews content created by peers’ writers.
- Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, and Pharmacovigilance teams.
- 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.
- Interact effectively with stakeholders in medical and pharmacovigilance departments.
- Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
- Provide deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA) as per agreed timelines and quality
- Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
- Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
- Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
- Work with selected vendors within the region to deliver the required deliverables as per the defined process.
- Design an overall plan of action basis end-customers feedback & improve course content and delivery.
- Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
- Liaise with the Medical department to prepare relevant & customized deliverables.
- 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)
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.