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United BioSource Corporation.
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London, Greater London
Senior Medical Writer
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Salary: HASH(0x562d3d4a34f8) |
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Overview
Brief Description: Coordination of medical writing activities for Medical Writing projects. Independently write, edit, and compile clinical/regulatory documents specifically protocol development for all phase clinical trials, clinical study reports, support NDA/IND submissions, investigator related documents as well as reports for safety and epidemiology projects such as REMS and KABS. Requirements: Bachelor's degree in biological sciences or equivalent At least 8 years' experience in medical writing within the pharmaceutical/CRO industry Advanced word processing skills (Microsoft Word) including proficiency with tables Strong organization and prioritization skills Attention to detail/high degree of accuracy Ability to clearly and effectively communicate and interact with clients Strong analytical, problem-solving, and data interpretation skills Good communication skills Good interpersonal skills Ability to work both independently and as a part of a project team Exposure and familiarity with relevant ICH and FDA guidelines Understanding of templates and styles Supervisory Responsibilities: None Specific Job Duties: Preparation of departmental deliverables, such as clinical protocol development (required), KABs, REMS, clinical study reports for all phases, IND, NDA and CTD summary documents, and manuscripts for publication Represent Medical Writing on UBC and client project teams for project planning, timeline development, and resource management Knowledge of the utilization and implementation of sponsor related style guides Participate in proposal preparation and resource allocation Proactively manage timelines for medical writing deliverables Represent Medical Writing at bid defenses and internal meetings Assist in the development of key messaging and operational procedures Coordination/consultation with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects Develop/maintain medical writing SOPs Perform quality control and peer reviews of documents and assess compliance with regulatory requirements, clients requests, and SOPs Inform Medical Writing Department head of potential problems/challenges Conduct comment resolution meetings Other duties as assigned LI-CF1 ABOUT UBC United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use. Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care. You can find out more by visiting www.ubc.com