Senior Medical Regulatory Writer

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About the role

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

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