What are the responsibilities and job description for the Sanofi is hiring: Medical Regulatory Writer in Baltimore position at Sanofi?
Medical Regulatory WriterApply locations : HyderabadTime type : Full timePosted on : Posted 9 Days AgoTime left to apply : End Date : January 30, 2025 (30 days left to apply)Job requisition id : R2771162About the jobOur 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, 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.Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.Develop and maintain TA expertise.Collaborate 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.Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product.Interact effectively with stakeholders in medical and pharmacovigilance departments.Assist other medical regulatory writers in developing knowledge and sharing expertise.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.Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.Work with selected vendors within the region to deliver the required deliverables as per the defined process.Prepare / review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.Remain abreast of Sanofi Policy or Quality Documents evolution.Work closely with Clinical / Medical teams in regions / areas to identify medical writing needs and assist in developing assigned deliverables.Proactively liaise with the Clinical / Medical / Pharmacovigilance / Biostats / Legal / Regulatory / corporate affairs departments to prepare relevant & customized deliverables.About youExperience : >
2 years of experience in regulatory writing for the pharmaceuticals / healthcare industrySoft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment.Technical 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 English language knowledge (to read, write and speak)Pursue progress, discover extraordinaryBetter 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!#J-18808-Ljbffr
