Job title: Expert Medical Regulatory Writer
Job description: Mission statements * Write and/or edit under guidance high quality clinical and safety documents for submission to regulatory authorities to support marketing authorization application, renewals, and maintenance activities including complex Clinic
Mission statements Write and/or edit under guidance high quality clinical and safety documents for submission to regulatory authorities to support marketing authorization application, 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), addendum to clinical overview (ACO), Risk Management Plans (RMP) ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, and responses to Health Authorities Queries, immunogenicity reports. 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. Participate in planning of analysis and data presentation to be used as an ad-hoc member of the Clinical Trial Team (CTT), core member of the Clinical Submission Teams (CST) and extended member of the Global Clinical teams (GCT) and Safety management team (SMT) Develops and maintains TA expertise and to provide document-related advocacy to other line functions Reviews content created by peers writers and act as a coach, mentor, trainer for development of writers for the new document type Work with minimal supervision and support development of medical regulatory writers Agile and knowledgeable to be able to work across TA. Duties & Responsibilities Work Area 1. People Maintain effectiveness 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 Interact effectively with stakeholders on medical and pharmacovigilance departments Constantly assist other medical regulatory writers in developing knowledge and sharing expertise 2. Performance Provide deliverables (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality 3. Process Act as an expert in the field of medical regulatory writing and maintain on regulatory requirement for countries supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant element of medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per defined process Design an overall plan of action basis end-customers feedback & improve course content and delivery 4. Customer Work closely with Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with Medical department to prepare relevant & customized deliverables Collaborate with CTT, CST, GCT and SMT Knowledge, Skills & Competencies / Language Therapy Area Exposure Diabetes Familial hypercholesterolemia Cardiovascular disease Multiple sclerosis, Immunology Oncology Market access Emerging markets Generics Vaccines Vitamins and supplements Digestive Allergies Parkinson Haemophilia Rare diseases Rare blood diseases Stakeholder management Project management Regulatory Procedures Qualifications Advanced degree in life sciences/ pharmacy/ similar discipline (Phd, Masters, or Bachelors in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Excellent English language knowledge (Spoken and Written) Requirements of the job 8 years of experience in regulatory writing for the pharmaceuticals / healthcare industry Expert knowledge of and demonstrated accomplishment in global registration of drugs Excellent communication skills (written, verbal and presentation) Substantial knowledge of biostatistics principles Experience of managing global, cross-functional teams and working in Matrix environment Demonstrated ability to motivate, coach or mentor people. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Location: Hyderabad, Telangana
Job date: Fri, 14 Jan 2022 23:16:30 GMT
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