Global Medical Expert
- Sanofi
- 4 - 8 years
- Hyderabad
- 3 months ago
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Job Description
Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors
Essential Job duties and responsibilities:
- Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs.
- Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations.
- Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP).
- Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards.
- Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams.
People:
- Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance 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 the medical regulatory writing team in developing knowledge and sharing expertise
Performance:
- Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality
Process:
- Provide medical strategic insights & evaluation related to Company's portfolio.
- Contribute to the management of the marketing authorization dossiers of the current related portfolio.
- Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported.
- Assist the assigned medical team in conducting 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 when required within the region to deliver the required deliverables as per the defined process
- Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery.
Stakeholders:
- 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 ensure relevant & customized are delivered per expectation
About you
- Experience: 5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine
- 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: Medical degree MBBS; MD
- Languages: Excellent knowledge of the English language (spoken and written)
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Healthcare & Life SciencesRole Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: SanofiLocation(s): Hyderabad
Keyskills: Regulatory Affairs Pharmacovigilance PBRER DSUR Clinical Trials Aggregate Reporting PSUR Medical Writing Drug Safety Strategic documents Clinical Clinical Study Report
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