Manager, Medical Writing FSP

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Manager Medical Writing – Make an Impact at the Forefront of Innovation As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Manager Medical Writing, you will manage the performance and workload of Medical Writers and provide short-term and long-term resource planning to assign projects to appropriate and available staff. You will supervise the preparation of Medical Writing deliverables and organize processes for the completion of projects within established timelines. You will evaluate the timeliness and quality of deliverables and act as a resource for questions relating to study design, adverse event reporting, and statistical analyses. You will assist writers in the presentation and interpretation of data and perform senior reviews to ensure overall adherence to departmental standards. Additionally, you will participate in the preparation and review of group SOPs and WPDs, evaluating compliance with SOP/WPD on an ongoing basis. You will give marketing presentations to potential clients on the capabilities of the Medical Writing department and interact with Bids and Contracts and Business Development to prepare budgets and proposals for Medical Writing projects. You will also participate in the development of training programs for Medical Writing and ensure direct reports are adequately trained. What You’ll Do: • 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 semimonthly time sheets. Assist staff to forecast project-related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions • Supervises 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. • Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare proposals for Medical Writing projects. • 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. • Writes and coordinates other documents for submission to regulatory agencies, including IND, NDA, and CTD items. Education and Experience Requirements: • Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience. • 2 years relevant experience in medical writing, preferably within the pharmaceutical industry • 1+ year of leadership responsibility Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: • Ability to supervise, evaluate, and mentor departmental personnel • Ability to oversee assignments, monitor staff workload, and provide guidance for completion of assignments • Ability to create and modify project timelines, allocate resources, and forecast departmental workload • In depth knowledge of departmental processes and ability to contribute to improving and developing processes • Excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present extremely complex data • Effective communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits • Ability to develop, review, and modify proposals and budgets for presentation to clients Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations with occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.