Sr Medical Writer - Early Development
Thermo Fisher Scientific
Mumbai, Maharashtra, India
A day in the Life: Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies. Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes. May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. Represents the department at project launch meetings, review meetings, and project team meetings. Keys to Success: Education Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Experience Previous regulatory medical writing experience required (comparable to 5+ years). Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Knowledge, Skills, Abilities Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills Strong project management skills Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)