Global Medical Expert

5+ years

Not Disclosed

Hyderabad Mumbai

10 Dec. 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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
% of Travel Expected: As per business need
Hiring Manager: Head of Scientific Communications/Team Lead

About the Job:
Sanofi Business Operations is a key internal resource organization based in India, designed to centralize processes and activities to support various departments such as Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Our goal is to be a strategic and functional partner for global tactical deliveries to Medical, HEVA, and Commercial organizations within Sanofi.

As a Global Medical Expert, you will work alongside a team of medical regulatory writers to develop medical expertise, ensuring compliance with regional regulations (FDA, EU, etc.). You will support the maintenance of marketing authorizations across therapeutic areas and collaborate closely with global teams including Medical Leads, Regulatory Affairs, Pharmacovigilance, and external vendors.

Main Responsibilities:

Medical Regulatory Writing:
- Provide medical assessments using updated clinical evidence and oversee the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk Assessments, Expert Statements, and Health Authority responses.
- Draft extended study synopses in collaboration with Real World Evidence (RWE) experts, ensuring compliance with SOPs, GCP, and other relevant regulations.
- Write key medical and clinical sections of Common Technical Documents (CTD) and Briefing Packages (BP).
- Approve compassionate use requests for Sanofi medicinal products used in serious or life-threatening diseases outside of clinical trials.
- Secure the timely delivery of high-quality medical documents in compliance with internal and external standards.
Collaboration with Stakeholders:
- Maintain effective relationships with internal stakeholders (Medical, Regulatory, Pharmacovigilance teams) to ensure timely delivery of regulatory documents.
- Collaborate with global medical leads and other teams to meet specific project requirements.
- Assist the medical regulatory writing team in developing expertise and sharing knowledge.
Medical Strategic Insights & Evaluation:
- Provide strategic insights into Sanofi’s medical portfolio, managing marketing authorization dossiers and maintaining regulatory requirements across supported regions.
- Support the assigned medical team in conducting comprehensive medical regulatory writing needs analysis.
Process Improvement & Vendor Management:
- Contribute to process improvements and implement elements of the medical regulatory plan for the region.
- Work with selected vendors to deliver the required documents in line with defined processes.

About You:

Experience: At least 5 years of experience in medical affairs, clinical development, or pharmacovigilance with expertise in therapeutic areas such as cardiovascular, metabolism, diabetes, CNS, oncology, anti-infectives, or internal medicine.
Soft Skills: Strong stakeholder management, excellent communication skills, and the ability to work independently and within a team environment.
Technical Skills: Expertise in medical operational excellence, risk management, and technical medical writing and editing.
Education: Medical degree (MBBS, MD).
Languages: Proficiency in English (spoken and written).

Why Choose Us?

Be part of a global team driving the future of healthcare innovation.
Explore diverse career growth opportunities within Sanofi.
Enjoy a competitive rewards package, including health and wellness benefits, and gender-neutral parental leave.

Pursue Progress, Discover Extraordinary
Sanofi is committed to creating miracles of science to improve people's lives. By joining us, you will help shape the future of global healthcare, while working in an inclusive, dynamic, and diverse environment. Together, we will drive progress and discover extraordinary solutions.

At Sanofi, we believe in equal opportunities for all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and discover more about our Diversity, Equity, and Inclusion initiatives at sanofi.com.

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