Job title: Head Medical Regulatory Writing (MRW) and Medical Information (MI) Business Operations

Location: Hyderabad

About the job

Our Team:

In alignment with our strategic vision to enhance operational efficiencies and consolidate resources within business operations, we are seeking a dynamic and visionary leader to spearhead our MRW and MI activities at the Hyderabad location.

Main responsibilities:

Leads a team of medical regulatory writers, medical information writers, project managers and specialists (electronic documentation, Periodic Report Expert coordination, Trial Master File management), and global medical experts with different levels of expertise. Supervises and provides guidance to project managers for their respective roles within the team. Coaches and develops Medical regulatory writers and global medical experts on contents, methods, and processes pertaining to medical regulatory writing.

Essential Job duties and responsibilities: 1) Developing guidance for reviewing and approving compassionate use of individual medical requests for use of Sanofi medical products for serious or life-threatening diseases for treatments outside the clinical trials. 2) Leading the research and authoring of scientific response documents under the direction of the global medical information team in support of global and local medical information activities. 3) Ensure compliance with regulatory requirements for activities supported. 4) Oversee the development of high-quality clinical and safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to Clinical Overview, Clinical Study Reports, ID cards, Clinical Evaluation Reports, Briefing Packages, and medical section of CTA. 5) Develops guidance for effective coordination and execution of all TMF documentation-related activities. 6) Coaches and develops expert medical regulatory writers on contents, methods, and processes pertaining to high-quality clinical and safety documents for submissions to regulatory authorities. 7) Secure delivery of high-quality medical documents in time and in compliance with internal and external standards. 8) Participates in planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 9) Develops and maintains medical regulatory expertise

Collaborates effectively with stakeholders: Scientific Communication global or local teams, Medical regulatory writing global or local teams, Medical Information global and/or local teams, TMF management team, Clinical Study Team (Sanofi internal and external associates including Sanofi Business Operations and CRO), and Pharmacovigilance teams

• People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated business unit and product- with an objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical, clinical, and pharmacovigilance departments. 3) Constantly assists the medical regulatory writing team and medical information team in developing knowledge and sharing expertise.

• Performance: Secure deliverables (PSR coordination activities, TMF activities, EDS activities, PBRERs, ACOs, CSRs, ID cards, CERs, Briefing packages, medical sections of CTA, and medical information activities etc) are supported 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, teams supported. 2) Assist the assigned medical team in conducting 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) Ensures the timely coordination of PSRs, electronic documentation activities, TMF activities, and GMI activities for the identified year and region. 5) Work with selected vendors within the region to deliver the required deliverables per the defined process. 6) Design an overall plan of action basis end-customers feedback and improve course content and delivery

• Stakeholders: 1) Work closely with the medical team in regions/ areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the medical department to ensure relevant & customized deliverables are delivered per the expectation

About you

• Experience: ≥10 years of experience in regulatory writing for the pharmaceuticals/ healthcare industry, knowledge of regulatory procedures, with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, onco