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Medical Senior Writer (630000) at Zimmer US

Posted in Writing/Editing 30+ days ago.

Type: Full-Time
Location: Warsaw, Indiana





Job Description:

Job Summary

Zimmer Biomet is a global medical technology leader. 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 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.  

Principal Duties and Responsibilities


  • 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

  • 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

Expected Areas of Competence


  • 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

  • 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

Education/Experience Requirements


  • B.A. in the Humanities (English, journalism or Library Science preferred), M.A. degree preferred; a background in biological sciences or equivalent work experience; statistical courses and/or experience desirable; 

  • 5+ years of documented professional experience in clinical investigation, medical writing, systematic review and clinical data appraisal.

  • 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.

Travel Requirements

Up to 5%

Additional Information

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.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/F/Vet/Disability

Compensation Range:  $107,000 - $120,000





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