At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
The Sr. 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.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
How You'll Create Impact
- 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
What Makes You Stand Out
- 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
Your Background
Required Technical Skills
- Proven experience in clinical, regulatory, and technical medical writing, including development of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSUR) in compliance with MEDDEV 2.7.1 Revision 4 and EU MDR 2017/745.
- Minimum of five (5) years of documented professional experience in clinical investigation, medical writing, systematic literature review, and clinical data appraisal.
- Experience in clinical, regulatory, or product engineering roles within the medical device industry is required.
- Strong preference for candidates with experience in the orthopedic medical device sector.
Education And Experience Requirements
- Experience Range: 5+ Years.
- Requires a Bachelor's degree in health, life sciences, engineering or a similar discipline required.
Travel Expectations
Up to 5%
EOE/M/F/Vet/Disability
