Job Description

　　At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

　　Discover Impactful Work:

　　This position supervises the activities of the Medical Writers and may coordinate medical writing services across locations within the United States. The Manager, Medical Writing uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data. The Manager, Medical Writing also writes and coordinates other documents for submission to regulatory agencies, including IND, NDA, and CTD items.

　　A day in the Life:

　　Supervises Medical Writers.Provide short-term and long-term resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve time sheets. Assist staff to forecast project related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotionsSupervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on the guidelines and requirements of the ICH, FDA and other relevant agencies.Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained.Uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data.

　　Keys to Success:

　　Education

　　BS/BA (scientific discipline preferred) with 6 years relevant experience or Advanced degree with 3 years relevant experience

　　Experience

　　2 years relevant experience in medical writing, preferably within the pharmaceutical industry1 year supervisory/management experience or equivalent combination of education, training, and experience that provides the individual with the required

　　Knowledge, Skills, Abilities

　　Must possess the ability to supervise, evaluate, and mentor departmental personnelMust possess the ability to delegate tasks and facilitate completion of assignmentsMust possess evidence of strong management skills, including the ability to create and modify budgets, project timelines, allocate resources, and forecast departmental workloadMust possess well-developed presentations skills for use in client presentationsMust demonstrate innovation in developing new ideas related to Medical Writing, including process improvementsMust possess excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present extremely complex data

　　Benefits

　　We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Accessibility/Disability Access

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