Global Medical Expert

5+ years

Not Disclosed

Hyderabad

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: MBBS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Medical Expert
Location: Hyderabad/Mumbai
Job Type: Permanent, Full-time
Travel: As per business needs

About the Team:
Sanofi Business Operations is an internal resource organization based in India, focusing on centralizing processes to support various departments, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. The organization strives to be a strategic partner for global teams and plays a crucial role in delivering medical, regulatory, and commercial activities.

Main Responsibilities:

Medical Regulatory Writing:
- Responsible for drafting and reviewing high-quality medical documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk Assessments, Expert Statements, and other regulatory documents for the relevant therapeutic areas or products.
- Ensure the execution of strategic documents in collaboration with other teams while ensuring compliance with SOPs, GCP, and regulations.
Cross-functional Collaboration:
- Collaborate with Global Medical Leads, Global Regulatory Affairs, Pharmacovigilance, and vendors to ensure compliance and high-quality outputs.
- Work closely with stakeholders to ensure the timely delivery of medical documents aligned with internal and external standards.
Strategic Insights and Support:
- Provide medical strategic insights and evaluation regarding Sanofi’s portfolio.
- Contribute to the management of marketing authorization dossiers and assist in developing regulatory documents for various regions.
Medical Writing Leadership:
- Oversee the development of medical regulatory content, including the medical sections of regulatory documents, such as CTDs, briefing packages, and clinical evaluation reports.
- Assist in drafting study synopses in collaboration with RWE experts.
Stakeholder Management:
- Maintain effective relationships with medical, regulatory, and pharmacovigilance departments to ensure customized deliverables are met.
- Proactively assist the medical regulatory writing team in sharing knowledge and expertise.
Documentation and Compliance:
- Support the creation of essential medical documents for the global product portfolio and ensure compliance with regulatory requirements in different regions.
- Act as an expert in medical regulatory writing and maintain knowledge of applicable regulations and standards.

About You:

Experience: Minimum of 5 years of experience in supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance, with experience in therapeutic areas such as cardiovascular, metabolism, CNS, oncology, or internal medicine.
Soft Skills: Strong stakeholder management, communication skills, and ability to work independently and within a team.
Technical Skills: Expertise in medical regulatory writing, operational excellence, and project management skills.
Education: Medical degree (MBBS, MD).
Languages: Excellent proficiency in English (both spoken and written).

Why Sanofi:
At Sanofi, we are united by a shared mission to pursue progress and discover extraordinary. We offer equal opportunities to all candidates, regardless of their background, race, color, or identity. Join us and help make a lasting impact on the lives of patients across the world.

For more details, visit Sanofi’s website.

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