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Medical Writer
Location:
Lexington, MA
Description:
About the Department Our Boston Research and Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R and D continuum, from early research through late:stage clinical development. Here, we are building for the future, creating a distinct R and D community based on collaboration, partnerships, and cutting:edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R and D hub merges biotech speed and agility with large pharmaceutical company quality, resources,and stability,uniting the best of both worlds to develop new medicines for patients. The Position The Medical Writer works closely with cross:functional project teams to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Medical Writer performs work independently under the supervision of more experienced personnel. Relationships The Medical Writer (MW) reports to an Associate Director of Medical Writing. The MW is expected to develop and maintain a network of internal relationships with global and local cross:functional study teams, including personnel from Medical and Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non:clinical Development. Essential Functions :Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which may include:stylelist:style:type:circle::Clinical study protocols and protocol amendments:Clinical study reports (CSR):Investigator brochures (IB):Informed consent and assent forms:Lay summaries of clinical trial results:Clinical evaluation plans (CEP) and clinical evaluation reports (CER):Pediatric investigational plans (PIP):Orphan Drug applications:Breakthrough Therapy Designation requests:Shares better practices to optimize and simplify the way we workstylelist:style:type:circle::Contributes to process improvements within the medical writing area:Actively participates in relevant meetings, training sessions, and seminars in the department and relevant project(s):Leads meetings and drives decisions concerning project/trial:specific medical writing issues:Resolves document content issues and questions arising during the writing processstylemargin:bottom:11.0px::General Tasks:stylelist:style:type:circle::Interprets and accurately presents clinical and statistical data in a clear, concise format:Can identify and resolve problems related to Medical Writing projects, processes, or tasks, with management support as needed:Maintains up:to:date knowledge and understanding of the laws, regulations, industry standards, and company policies/procedures relevant to Medical Writing:Remains current with respect to the literature on Novo Nordisk therapeutic areas and competitor products Physical Requirements Approximately 10 overnight travel. May include travel outside the US. Qualifications :Education Level:stylelist:style:type:circle::Minimum of BS/BA, preferably in a health:related or scientific discipline:Experience Level:stylelist:style:type:circle::5+ years of relevant experience. Minimum of 3 years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment:Equivalent experience with advanced degree or in other settings will be consideredstylemargin:bottom:11.0px::Specific or technical job skills:stylelist:style:type:circle:
Posted:
May 16 on Tip Top Job
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More About this Listing: Medical Writer
Medical Writer is a Media, Journalism & Newspaper Jobs Medical Writer Job located in Lexington MA. Find other listings like Medical Writer by searching Oodle for Media, Journalism & Newspaper Jobs Medical Writer Jobs.
Medical Writer is a Media, Journalism & Newspaper Jobs Medical Writer Job located in Lexington MA. Find other listings like Medical Writer by searching Oodle for Media, Journalism & Newspaper Jobs Medical Writer Jobs.