Medical Regulatory Writer

2+ years

Not Disclosed

Hyderabad

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/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

Job Title: Medical Regulatory Writer
Company: Sanofi Business Operations
Location: India (specific location not provided)

About Sanofi:

Sanofi Business Operations is a resource organization within Sanofi, centralized in India to support multiple functions such as Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital. This team is focused on providing tactical support to Medical, HEVA, and Commercial organizations globally. At Sanofi, we pursue progress and innovation, aiming to make extraordinary discoveries that improve the lives of patients.

Main Responsibilities:

As a Medical Regulatory Writer, you will be responsible for writing, editing, and managing various medical documents in compliance with regulatory guidelines. You will work closely with global and local teams to produce high-quality documents and ensure timely delivery.

Essential Duties and Responsibilities:

Medical Document Writing and Editing:
- Write and/or edit safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports (PBRER), clinical overviews, Disease and Product ID Cards, product alerts, and trial transparency documents.
- Ensure all deliverables are in compliance with internal and external standards and guidelines.
Collaboration:
- Work under the guidance of mentoring medical writers to plan data analysis and presentation.
- Collaborate with Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and Regulatory teams.
- Maintain effective relationships with end stakeholders in the medical scientific community.
People Management and Stakeholder Engagement:
- Interact with stakeholders across Medical, Clinical, Pharmacovigilance, and Regulatory departments.
- Assist other medical regulatory writers in developing their knowledge and sharing expertise.
- Support in managing relationships with vendors and external partners.
Performance and Process Management:
- Deliver medical documents (e.g., PBRER, ACO, Product Alerts, clinical trial data) on time and with high quality.
- Ensure audit and inspection-readiness of all medical documents.
- Track postings and archive materials in relevant systems.
- Stay updated on Sanofi’s evolving policies and quality documents.
Regulatory Compliance and Quality:
- Maintain an in-depth understanding of medical regulatory requirements for countries supported.
- Track and review trial information for websites such as CT.gov, EUCTR, EUDRACT, and others.

Qualifications:

Experience:

Minimum of 2 years of experience in regulatory writing for the pharmaceutical/healthcare industry.

Soft Skills:

Strong stakeholder management and communication skills.
Ability to work independently and as part of a team.
Vendor management experience.

Technical Skills:

Excellent technical editing and writing skills.
Proficiency in data retrieval, interpretation of scientific data, and medical literature screening.
Knowledge of ICH and GCP/GVP guidelines.
Ability to summarize and edit scientific information for specific audiences.

Education:

Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Master's, or Bachelor's in Science, PharmD).
Medical degree (MBBS, BDS, BAMS, BHMS, MD) is also acceptable.

Languages:

Excellent command of the English language (reading, writing, and speaking).

Why Sanofi?

At Sanofi, we believe progress happens through people. We offer opportunities for growth and development, with a culture of innovation and inclusion. Whether you're pursuing career advancement or exploring new challenges, Sanofi supports your professional and personal growth every step of the way.

We are an equal-opportunity employer and value diversity in our workforce. We welcome candidates from all backgrounds to contribute to our mission of making extraordinary changes happen in healthcare.

Apply Now:

If you're ready to pursue progress and make a difference in healthcare, join Sanofi's mission to discover extraordinary solutions.

Visit our careers page to apply.

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Medical Regulatory Writer

Job Description

About Sanofi:

Main Responsibilities:

Qualifications:

Why Sanofi?

Apply Now:

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