Medical Regulatory Writer

Sanofi

2+ years

Not Disclosed

Hyderabad

10 Feb. 6, 2025

Job Description

Job Type: Full Time Education: PhD/D Pharma/PharmD/MBBS/BDS/BAMS/BHMS/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

Here is the rewritten job description with a unique slug:

Medical Regulatory Writer | Hyderabad, India | Permanent | Sanofi

Posted on: Dec. 12, 2024
Closing on: Mar. 03, 2025

About the Job:

Sanofi is seeking a Medical Regulatory Writer to join their Business Operations team in Hyderabad. In this permanent, full-time role, the Medical Regulatory Writer will be responsible for writing and editing high-quality safety documents and medical regulatory content, ensuring compliance with internal and external standards.

Key Responsibilities:

Medical Writing & Editing:
- Write and/or edit safety documents, Periodic Benefit-Risk Evaluation Reports (PBRER), medical sections of clinical overviews, product alerts, trial transparency documents, and more.
- Ensure timely delivery of high-quality medical documents that comply with internal and external standards.
Collaboration & Stakeholder Interaction:
- Collaborate with global and local scientific communication teams, medical regulatory writing teams, pharmacovigilance teams, and regulatory teams.
- Build effective relationships with medical scientific stakeholders to develop regulatory content as required.
Process & Compliance Management:
- Author, review, and act as an expert in medical regulatory writing, maintaining regulatory requirements.
- Assist with needs analysis and implement elements of the medical regulatory plan.
- Track and ensure audit and inspection-readiness for regulatory material.
Quality & Timeliness:
- Ensure that PBRERs, ACOs, product and disease ID cards, product alerts, and other regulatory documents are delivered according to agreed timelines and quality standards.
Vendor & Risk Management:
- Work with vendors to deliver required materials and manage risk effectively.
- Track postings and file materials as per regulatory requirements.

About You:

Experience:
- Over 2 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
Soft Skills:
- Strong stakeholder management and vendor management.
- Excellent communication skills and ability to work both independently and collaboratively within a team.
Technical Skills:
- Strong medical writing and editing skills.
- Knowledge of ICH, GCP/GVP, and ability to interpret scientific data and summarize it for specific audiences.
- Proficient with computer applications related to medical writing and regulatory processes.
Education:
- Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Master's, Bachelor's in science, PharmD, etc.)
- Medical degrees such as MBBS, BDS, BAMS, BHMS, or MD are also welcome.
Languages:
- Excellent command of the English language (spoken and written).

What We Offer:

At Sanofi, we are committed to fostering an inclusive and diverse environment. Join us as we work together to make meaningful progress in healthcare and improve lives globally.

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Medical Regulatory Writer

Job Description

Medical Regulatory Writer | Hyderabad, India | Permanent | Sanofi

About the Job:

Key Responsibilities:

About You:

What We Offer:

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