Medical Writing Manager

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY DESCRIPTION The , Medical Writing Manager is a subject matter expert at preparing complex clinical and medical writing deliverables. This role is a leader in the medical writing space who authors regulatory and clinical documents in accordance with internal procedures and global regulatory requirements, while leading collaboration with cross-functional stakeholders supporting clinical, regulatory, and business objectives. REPORTING & MANAGEMENT SCOPE SUPERVISION RECEIVED: Reports to the Director of Medical Communications SUPERVISION EXERCISED: May mentor, train or supervise junior medical writers. KEY RESPONSIBILITIES Leads and manages their product teams. Subject Matter Expert for who excels in identifying pertinent internal and external sources of clinical data. Leads product teams for evaluation and documentation of literature searches of peer review publications. Reviews, authors and mentors Clinical Evaluation Reports & associated documents in accordance with EU MDR and Integra internal procedures. Independently able to interact with regulatory bodies to answer questions as needed. Reviews and prepares clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier. Reviews and authors clinical study reports, manuscripts for publication, posters, abstracts or internal white papers. Forecasts, manages, and meets project deadlines. Takes the initiative to report on project status; anticipates and alerts leadership and internal customers of potential project difficulties. Develops tools, templates, best practices and standard operating procedures to ensure efficient preparation of high-quality medical writing deliverables. Ensures template sections of documents remain current and consistent across documents/Business Units as applicable. Develops and maintains effective working relationships with co-workers, internal customers, and external vendors. Develops/executes publication plans & strategy through the development of high-quality publications, abstracts, posters, and presentations. REQUIRED SKILLS & MINIMUM QUALIFICATIONS Education: Master's degree or PhD in a scientific or healthcare discipline preferred Experience: 10 years in medical device industry with a minimum of 8 years as a medical writer. Skills: Advanced medical writing, clinical regulatory expert, project management, strong attention to detail, and expert with MS Office and reference management tools. Tools And Equipment Used: Computers, standard office equipment, Microsoft Office Suite, Adobe Acrobat, document management and reference management systems. Salary Pay Range: $95,000.00 - $130,000.00 USD Salary In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long- term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences ( Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law ( | EOE including Disability/Protected Veterans ( Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ( If you have difficulty using our online system due to a disability and need an accommodation, please email us at View email address on click.appcast.io. #J-18808-Ljbffr