Senior Medical Writer (708571) - REMOTE job at Zimmer Biomet

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

The fully remote Senior Medical Writer will be responsible to independently identify pertinent internal and external sources of clinical data and conduct literature searches of peer review publications and to prepare Clinical Evaluation documents in accordance with European Union guidance and Zimmer Biomet internal procedures using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data.

This will also include:

• Project management of CER or PMS activities across the clinical team.
• Summarize findings and write risk versus benefit analyses and conclusions based on clinical data, peer review publications, risk management files and post market data in accordance with European Union guidance.
• This may also include writing study protocols, investigational plans, manuscripts for publication or internal white papers.
• Work with Clinical Affairs, Regulatory Affairs, Post-Market Surveillance, Risk Management and Development Engineering groups to verify and approve content of final Clinical Evaluation documentation.
• Prepare reviews of peer-reviewed literature for inclusion in Zimmer Biomet post-market surveillance documents.
• File work in the Clinical Evaluation archives, provide clinical data searches and documentation as a service to various functions within Zimmer Biomet.

• Manages the writing, reviewing and maintenance of controlled documentation according to regulatory requirements 
• Manages the writing, editing, documenting and publishing of clinical research articles, white papers and selected internet content on Zimmer Biomet products and technologies
• Functions as an interdepartmental information liaison and manages requests for clinical research, technical documentation, and support of publications and technical presentations
• Identify pertinent internal and external sources of clinical data for the Zimmer Biomet products necessary to fulfill the regulatory requirements
• Design literature and data registry searches using relevant key words, execute the searches

• Excellent written and verbal communications skills
• Strong bibliographic research and editorial skills
• Strong organizational and attention to detail skills
• Computer proficiency in MS Office applications, QuarkXPress, and Photoshop
• Knowledge of ethical publication standards of the American Medical Writers Association (AMWA) and/or European Medical Writers Association (EMWA)
• Knowledge FDA / MDR regulations for medical devices
• Knowledge of international regulations for medical devices
• Demonstrated project management skills
• Skilled in working closely with writers and publishers
• Excellent written and verbal communications skills
• Strong bibliographic research and editorial skills
• Strong organizational and attention to detail and proofreading skills.
• Computer proficiency in MS Office applications and proficiency in or ability to learn tool for managing bibliographies, citations and references
• Knowledge of ethical publication standards of the American Medical Writers Association (AMWA) and/or European Medical Writers Association (EMWA)
• Knowledge of regulatory compliance for medical devices.
• Demonstrated project management skills
• Skilled in working closely with writers and publishers
• Strong ability to interpret and disseminate relevant product information.
• Knowledge of clinical research methodology, tools & processes 
• Understanding of statistical methods
• Ability to critically analyze and interpret scientific data
• Have an analytic and strategic mindset
• Ability to work within tight deadlines, adjust to changes in priorities
• Ability to function independently
• Ability to identify problems and research possible solutions

• A minimum of a B.A. in the Humanities (English, journalism or Library Science preferred); M.A. degree preferred
• A minimum of five (5) or more years of documented professional experience in clinical investigation, medical writing, systematic review and clinical data appraisal required
• A background in biological sciences or equivalent work experience required
• Statistical courses and/or experience desirable
• Background in clinical, regulatory or product engineering in the medical device industry desired, with a strong preference to those with experience in the orthopedic industry

• Up tp 5%

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

EOE/M/F/Vet/Disability

Base Compensation: $109,000 - $115,000