Medical Writing Manager

Integra LifeSciences•US-NJ-xx-NA-Home-Office, NJ

2d•Onsite

About The Position

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. 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.

Requirements

Master’s degree or PhD in a scientific or healthcare discipline preferred
10 years in medical device industry with a minimum of 8 years as a medical writer.
Advanced medical writing, clinical regulatory expert, project management, strong attention to detail, and expert with MS Office and reference management tools.

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.