Job title: Senior Medical Regulatory Writer
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Hiring Manager: Head Medical Regulatory Writing / Team lead
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Location: Hyderabad
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% 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:
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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.
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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
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Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.
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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.
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Organize and prioritize workload/multiple requests to comply with agreed timelines and ensure that Sanofi’s business needs are met.
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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
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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
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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)
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Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment
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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
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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)
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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.
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