Job title: Senior MedInfo Regulatory Writer
Job description: Job Summary * Responsible for research and authoring of scientific response documents under the direction of Global Medical Information (GMI) team in support of global and local Medical information activities. * Responsible for execution of act
Job Summary Responsible for research and authoring of scientific response documents under the direction of Global Medical Information (GMI) team in support of global and local Medical information activities. Responsible for execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, document management proficiency. Essential Job duties and responsibilities Collaborates with GMI teams to execute content plans Conducts literature searches and reviews, extracts/summarizes complex data from scientific literature Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s) Adapts global scientific response documents for assigned countries Develops responses to escalated inquiries for assigned countries Develops contributions to US NDA Annual Reports Contributes to US compendia reviews Contributes to peer reviews Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. Develops and maintains Therapeutic Area expertise Reviews the content created by peer writers Knowledge, Skills & Competencies / Language Therapy Area Exposure: Diabetes, Familial hypercholesterolemia, Cardiovascular disease, Multiple sclerosis, Immunology, Oncology, Market access, Emerging market, Generics, Vaccines, vitamins and supplements, Digestive, Allergies, Parkinson, Haemophilia, Rare diseases, Rare blood diseases Stakeholder management Project management Medical Information Procedures Qualifications Advanced degree in life sciences/ pharmacy/ similar discipline, or medical degree or doctorate degree (PharmD, Ph. D, Master in science, MBA or equivalent) Excellent English language knowledge, written and communication skills 5 years of experience in regulatory writing for the pharmaceuticals / healthcare industry or equivalent experience in clinical setting At least 2-3 years of direct medical information experience in pharmaceutical company Knowledge about literature evaluation and multilevel response development 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: Sat, 01 Jan 2022 23:44:46 GMT
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