Add office photos
Employer? Claim Account for FREE
Sanofi
CompareProud winner of ABECA 2024 - AmbitionBox Employee Choice Awards
All Filters
247 Sanofi Jobs
Senior Medical regulatory Writer
Sanofi
posted 6d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Our Team:
Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, RD, Data Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main responsibilities:
Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews.
Essential Job duties and responsibilities: 1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned.
- People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
- Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality
- Process: 1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution.
- Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical / Medical / Pharmacovigilance / Biostats / Regulatory / Legal / Regulatory / Corporate Affairs departments to prepare relevant customized deliverables.
About you
- Experience : >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
- Soft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment
- Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications )
- Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
- Languages : Excellent knowledge of the English language (to read, write, and speak)
Employment Type: Full Time, Permanent
Read full job descriptionSanofi Interview Questions & Tips
Prepare for Sanofi roles with real interview advice
People are getting interviews at Sanofi through
People are getting interviews through
(based on 51 Sanofi interviews)
Referral
Job Portal
Company Website
Walkin
Campus Placement
30%
24%
18%
10%
6%
12% candidates got the interview through other sources.
High
Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What people at Sanofi are saying
What Sanofi employees are saying about work life
based on 1.1k employees
Flexible timing
Monday to Friday
Within city
Day Shift
Sanofi Benefits
View more benefits
Compare Sanofi with
Cipla
Compare
Sun Pharmaceutical Industries
Compare
DRJ & CO
Compare
Biocon Limited
Compare
GlaxoSmithKline Pharmaceuticals
Compare
Pfizer
Compare
Aurobindo Pharma
Compare
Zydus Lifesciences
Compare
Torrent Pharmaceuticals
Compare
Lupin
Compare
Abbott
Compare
Micro Labs
Compare
Novartis
Compare
Biological E
Compare
Granules India
Compare
Gland Pharma
Compare
Unichem Laboratories
Compare
Fresenius Kabi
Compare
ACG Worldwide
Compare
Novo Nordisk
Compare
Similar Jobs for you
Senior Statistical Modeler - Pipeline Engineer
3-7 Yrs
Hyderabad / Secunderabad
Share an Interview