Hyderabad Full time R2868332 **Job title** : _Senior Medical Regulatory Writer_ + _Hiring Manager: Head Medical Regulatory Writing / Team lead_ + _Location: Hyderabad_ + _% of travel expected: Travel required as per business need_ + _Job type: Permanent and Full time_ _About the job_ **Our Team:** _Sanofi Business Operations 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, CMO, R&D;, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, Market Access, and Commercial organizations in Sanofi, globally._ **Main responsibilities:** + _Write and/or edit high-quality documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including simple_ _Clinical Study Reports (CSR), simple CTD submission related documents , medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts, trial transparency documents, and other relevant document with expertise. Delivery of high-quality documents on time and in compliance with internal and external standards and guidelines. Works on documents with some supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews._ _Essential Job duties and responsibilities:_ + _Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer._ + _Develops and maintains TA expertise._ + _Reviews content created by peers' writers. Collaborates effectively with global or local cross functional teams e.g., Medical writing global or local teams, Pharmacovigilance teams, Regulatory Teams, Corporate Affairs Teams & others, based on the documents assigned._ + _Conduct project Kick-off meetings and align line functions on the requirements as per the periodic report planning requirements, author relevant sections of the periodic reports and assemble the rest of the sections, do quality and consistency check, resolve discrepancies and ensure consistency across the document_ + _Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts._ + _Support coordination for various documents with different line functions, to ensure timely receipt of information, its completeness, and incorporation into the template as per the regulatory requirements._ + _Organize and prioritize workload/multiple requests to comply with agreed timelines and ensure that Sanofi's business needs are met._ + _Lead and coordinate end-to-end PSR activities, including stakeholder alignment, data collection, authoring, validation, quality checks, and cross-functional collaboration to ensure timely, compliant, and high-quality report delivery_ + _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 4) Follow up with all contributors to ensure the timely completion of reports within specified regulatory timelines._ + _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. Ensure periodic safety reports are prepared, archived, and delivered as per agreed timelines in adherence with Sanofi's quality standards._ + _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) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 7) Remain abreast of Sanofi Policy or Quality Documents evolution. 8) Support the delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for periodic safety reports prepared, including appropriate archival of all relevant documents in the document management systems to meet Health Authority and Company-specific audit requirements. 9) Secure adherence to compliance procedures and internal/operational risk controls in accordance with applicable regulatory/company standards. 10) Perform transversal activities, including mentoring the newly joined team member, identifying the need for training, communicating the day-to-day potential challenges in deliverables, performing specific types of training, and participating in the development of new tools/initiatives. 11) Support Health Authority inspections/audits and development of corrective and preventive actions (CAPA) to address findings_ + _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, pharmacovigilance, clinical drug development, or closely related areas of responsibility; Preferably, a minimum of 2 years of relevant experience in authoring and co-ordination of medical reports; Direct pharmaceutical industry experience should be within comparable sectors or roles (periodic safety reporting/aggregate reporting)_ + **Soft skills** : _Stakeholder 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)_ electronic document management (preferably Veeva-vault), Knowledge of periodic safety report document lifecycle and electronic Document Management System, Understand regulatory (Health Authority) requirements related to document template and requirements of each section, Regulatory reports pre-submission readiness and submission, and excellent understanding of the drug development process, pharmacovigilance, GVP, GCP, and medical terminologies + **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)_ _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, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com ! **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 current 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.

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