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. Overview 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. Responsibilities Leads and manages their product teams. Subject Matter Expert for identifying pertinent internal and external sources of clinical data. Leads product teams for evaluation and documentation of literature searches of peer-reviewed publications. Reviews, authors and mentors Clinical Evaluation Reports & associated documents in accordance with EU MDR and 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. Reports on project status and alerts leadership of potential difficulties. Develops tools, templates, best practices and standard operating procedures to ensure efficient preparation of high-quality medical writing deliverables. Ensures template sections 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 and strategy through the development of high-quality publications, abstracts, posters, and presentations. 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 expertise, project management, strong attention to detail, and proficiency 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. Compensation and Benefits Salary range: $95,000.00 - $130,000.00 USD. Salary ranges are determined by role, level, and location. Individual pay is determined by factors including job-related skills, experience, and education or training. 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 location during the hiring process. Additional Information Subject to the terms of company plans, employees may participate in benefit programs: medical, dental, vision, life insurance, disability, business accident insurance, group legal, and savings plan (401(k)). 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, disability, or protected veteran status. This site is governed by applicable U.S. laws and regulations. For rights information, see EEO notices: EEO Is the Law | EOE including Disability/Protected Veterans. Accommodation requests can be directed to View email address on click.appcast.io. Unsolicited Agency Submission: Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. A formal written agreement is required before engaging any agency, and it must be executed by the Vice President, Talent Acquisition. #J-18808-Ljbffr