Medical Writing Specialist
Medical Writing Specialist
Zimmer Biomet
Job description
Looking to start a career in medical writing and regulatory clinical documentation? Zimmer Biomet is hiring a Medical Writing Specialist in Bengaluru.
Company Profile
Zimmer Biomet is a global medical technology firm that is dedicated to helping patients restore their mobility and improve their health via medical goods, digital solutions, robotics and data-driven technologies. Its India activities include a Global Capability Center that provides technology innovation, business services and cross-functional work for the larger organization.
Summary of Position
This is a Full-time Medical Writing Specialist role, located in Bengaluru, with a hybrid format of 3 days in office. The role involves the autonomous preparation of portions of regulatory clinical documents, including Clinical Evaluation Plans, Clinical Evaluation Reports, Post-Market Surveillance, Post-Market Clinical Follow-up, and Summary of Safety and Clinical Performance documentation.
Main Responsibilities
Prepare standard portions of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) independently.
Support the Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF) and Summary of Safety and Clinical Performance (SSCP) documentation.
Implement literature search tactics and record evidence appraisal outcomes.
Analyse National Joint Registry (NJR) data to support clinical evidence initiatives.
Prepare clinical safety, clinical performance and benefit risk evaluations summaries.
There should be clear traceability from source data to the regulatory obligations that apply.
Ensure that documents are in acceptable templates and appropriate for audit or inspection examination.
Partner with Regulatory, Clinical and Development teams to review and finalize document drafts.
Assist in maintaining uniformity in process and documentation across product lines.
Participate in internal peer review and adhere to established protocols.
Carry out quality checks related to formatting, references and traceability.
Raise compliance or risk issues and assist in their resolution as needed.
Educational Qualification
A Bachelor’s degree in Health, Life Sciences, Engineering or a relevant area is desirable.
The position also qualifies those who have a mix of education and related experience such as an Associate’s degree with four years of related experience or a high school diploma with six years of related experience.
For bachelor’s degree candidates, about two years of relevant experience is preferred.
Skills Needed
Previous medical or regulatory writing experience is preferred.
Medical device experience necessary.
Candidates should have exposure to clinical and regulatory documentation such as CEPs, CERs, PMS, PMCF and SSCP.
Candidates should have good spoken and written English.
Good writing skills for scientific and technical purposes
Familiarity with medical device clinical and regulatory submissions.
Ability to examine the literature and appraise the evidence available
Experience of working with National Joint Registry data
Familiarity with global medical device legislation and post market needs.
Strong analytical skills and synthesis of evidence skills
Good cross-functional communication
Ability to handle several documents and deadlines
High accuracy and eye for detail
Good planning and organizational skills
Knowledge of preparation for audit and inspection
Critical thinking skills
Interest in learning new regulatory standards
Ability to identify and escalate compliance or risk issues
Salary
The typical compensation of the Medical Writing Specialist post in Zimmer Biomet, Bengaluru is between ₹6.6 lakh to ₹8.1 lakh per year.
Career Advancement
This position provides an opportunity for professionals to broaden their experience in medical-device regulatory writing, clinical evidence assessment, literature search, post-market documentation and cross-functional collaboration.
How to Apply
Check out our employment portal and search for the Medical Writing Specialist post.
Click the advertisement to see the job details and how to apply.
Provide your data and upload your updated resume.
Submit the application.
Education
Bachelor's Degree
Key Skills
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