Global Medical Expert

5+ years

Not Disclosed

Hyderabad

10 Feb. 6, 2025

Job Description

Job Type: Full Time Education: MD/MBBS 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

Here's the rewritten job description with a unique slug:

Global Medical Expert | Hyderabad, India | Permanent | Sanofi

Posted on: Jan. 03, 2025
Closing on: Feb. 28, 2025

About the Job:

Sanofi is seeking a Global Medical Expert to join the Medical Regulatory Writing team. The role involves providing medical assessments and collaborating closely with global medical leads, regulatory affairs, and pharmacovigilance teams. The Global Medical Expert will also contribute to medical regulatory content development, ensuring compliance with regulatory requirements and maintaining high-quality deliverables on time.

Key Responsibilities:

Medical Regulatory Writing: Provide medical assessments, draft clinical documents, and review content related to PBRERs, ACOs, DSURs, and other regulatory activities for therapeutic areas or products.
Clinical Expertise: Contribute to the drafting of extended synopsis for studies in collaboration with RWE experts, ensuring compliance with GCP, SOPs, and regulations.
Stakeholder Collaboration: Work effectively with internal stakeholders such as medical leads, regulatory affairs, pharmacovigilance teams, and vendors to deliver quality medical documents.
Delivery & Quality Assurance: Ensure timely delivery of medical documents in line with internal and external standards.
Medical Strategic Insights: Provide medical insights and contribute to the management of marketing authorization dossiers.
Training & Knowledge Sharing: Assist in developing the medical regulatory writing team's knowledge and provide ongoing support for process improvements.

About You:

Experience:
- ≥5 years in pharmaceutical companies with expertise in medical affairs, clinical development, or pharmacovigilance.
- Experience in at least one of the therapeutic areas: cardiovascular, metabolism, CNS, oncology, anti-infectives, or internal medicine.
Soft Skills:
- Strong communication and stakeholder management skills.
- Ability to work independently and within a team.
Technical Skills:
- Medical operational excellence, time, and risk management.
- Excellent technical editing and medical writing skills.
Education:
- Medical degree (MBBS, MD) preferred.
Languages:
- Excellent spoken and written English.

What We Offer:

Sanofi provides an inclusive, dynamic work environment that fosters both professional and personal growth. Join us in pursuing progress and discovering extraordinary innovations together.

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Global Medical Expert

Job Description

Global Medical Expert | Hyderabad, India | Permanent | Sanofi

About the Job:

Key Responsibilities:

About You:

What We Offer:

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