**Our Team:** _Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D;, Data & Digital functions. Sanofi Business Operations 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 under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines._ _Essential job duties and responsibilities: 1)_ _Participate with support 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) 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, Product and Disease ID Cards, 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, and 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/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables._ About you · **_Experience_** _: >2 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 workplace._ · **_Technical skills_** _: As applicable (including but not limited to 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-ver _sed 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 English language knowledge (to read, write and speak)_ **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! We are an R&D; driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.

📌 Medical Regulatory Writer (Hyderabad)
🏢 Sanofi Group
📍 Hyderabad