Main responsibilities:
Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including complex Clinical Study Reports (CSR), complex CTD submission documents (clinical overview [CO], summary of clinical efficacy [SCE], clinical safety [SCS], clinical pharmacology [SCP], and biopharmaceutics [SBP]), medical section of Periodic Benefit-Risk Evaluation Report (PBRER), medical sections of addendum to clinical overview (ACO), Risk Management Plans (RMP), Product and Disease ID Cards, clinical evaluation report, Briefing packages, responses to Health Authorities Queries, and immunogenicity reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents acting as an SME on clinical deliverables,buddy or mentor to the medical and senior medical writers, efficiently peer reviews providing Scientific inputs.
Essential Job duties and responsibilities: 1)Leading complex submissions, contributing to key messaging meetings, providing expert content guidance for medical sections of CTD, and delivery of high-quality medical documents in time and in compliance with internal standards and external guidelines. 2) Participate in the planning of analysis and data presentation to be used as an ad-hoc member of the Clinical Trial Team (CTT), a core member of the Clinical Submission Teams (CST), and an extended member of the Global Clinical teams (GCT) and Safety management team (SMT). 3) Develops and maintains TA expertise and provides document-related advocacy to other line functions. 4) Reviews content created by peer writers and act as a coach, mentor, and trainer for the development of writers for the new document type. 5)Work with minimal supervision and support development of medical regulatory writers. 6) Agile and knowledgeable to be able to work across therapeutic areas.
Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, CTT, CST, GCT, and SMT.
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: 1)Provide deliverables (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality 2) Fair understanding of Product Alerts, and trial transparency documents with the agility to learn and contribute to situations of demands
Process: 1) Acts as an expert in the field of medical regulatory writing and maintains the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting 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 per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery 6) Substantial understanding of Product Alert Process and Trial Transparency documents with the ability to quickly develop expertise and contribute swiftly if the situation demands
Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with CTT, CST, GCT and SMT. 4) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables.
About you
Experience: ≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment, leading project teams
Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management; Expert knowledge of and demonstrated accomplishment in global registration of drugs)
Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters, or bachelor’s in science, D Pharma, Pharm D) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
Languages: Excellent knowledge of the English language (to read, write and speak)
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