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Sr Medical Writing Operations Specialist- TMF Cambridge United States,  

Posted on : 20 April 2017

Project Description

External Posting TitleSr Medical Writing Operations Specialist- TMF Job DescriptionThe primary purpose of this job is to contribute to the management and oversight of the Medical Writing and Clinical Trial Application (CTA) sections of Biogen s Trial Master Files (TMF), with particular focus on vendor oversight of any outsourced TMF activities.Job responsibilities include:• Works with Medical Operations management and stakeholders to develop and execute a comprehensive plan for outsourcing TMF activities to master service provider (MSP) vendors. Drafts appropriate statements of work.• Provides TMF training and guidance to staff as needed.• Performs and documents ongoing oversight of TMF vendor activities.• Performs regular TMF file review, completes any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies), and completes required file review documentation.• Participates in Inspection Readiness activities as a document subject matter expert.• Ensures timely filing of required Medical Writing and CTA documents to the TMF in compliance with Biogen procedures and standards, including quality control reviews, identification of missing documentation, and follow-up with authors or other stakeholders to obtain missing items.• Meets all deliverable timelines. LocationCambridge, MA, US Job CategoryRegulatory Requisition Number31145BR QualificationsQualifications:• Knowledge of, and 3+ years  direct experience with, Trial Master File required.• Exceptional attention to detail required. • Adept in oral and written communication.• Proven ability to multitask in a fast-paced environment• Ability to prioritize while adhering to project deadlines• Experience working with clinical research organization (CRO) staff preferred.• Understanding of the Drug Information Association (DIA) TMF Reference Model• Good understanding of the biotechnology/pharmaceutical industry and the clinical development process, including familiarity with International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines• Quality control experience preferred• Direct participation in regulatory agency inspections (including inspection readiness and interview process) preferred Education• Bachelor s or Master s degree or equivalent in Life or Health Science discipline About BiogenCorporate Overview Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options. Biogen was founded in 1978 and today serves patients in nearly 70 countries. A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion Global headquarters in Cambridge, MA, and international headquarters in Zug, Switzerland Our Science We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments. For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders. Biogen is revolutionizing biologics manufacturing, developing the industry s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines. Our Corporate Citizenship The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Nearest Major Market: Cambridge Nearest Secondary Market: Boston Job Segment: Operations Manager, Biotech, Pharmaceutical, Biology, Operations, Science


Cambridge, MA, US

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