Medical Technical Writer

| Pacheco, CA, USA
Employer Provided Salary: 90,000-102,000 Annually
Salary data is provided by the employer. Please note this is not a guarantee of compensation.
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Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.


The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.

Summary

Responsible for writing, reviewing, and editing clinical technical documentation for IVD medical devices including antibodies, reagents, ancillaries, and instrumentation. Will work with a dedicated team of medical, laboratory, and regulatory professionals to complete documentation and product registration requirements under the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 and ISO 13485.  Will collaborate with R&D, Regulatory, Quality, and Marketing to produce comprehensive product technical documentation that not only complies with IVDR but meets the highest standards of clarity, accuracy, and usability.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Writes, reviews, and edits technical documentation for IVD products. 
  • Translates complex scientific and technical information into a clear, concise, and user-friendly format for laboratory professionals. 
  • Researches and analyzes technical data, scientific literature, and regulatory guidelines to ensure accuracy and compliance of all technical documentation. 
  • Ensures consistency, clarity, and adherence to company procedures and quality management system in all written materials with an emphasis on continuous improvement.
  • Reviews existing technical documentation to incorporate updates, improvements, and changes. 
  • Participates in review meetings, design control activities, and regulatory submissions as needed. 
  • Remains current with industry trends, best practices, and regulatory developments related to literature reviews, clinical performance studies, and clinical trials in vitro diagnostics and medical device technical documentation. 
  • Other duties as assigned or required.  

Competencies

  • Bachelor’s degree or equivalent experience in Biochemistry, Biology, Immunology, or a related field with 3-5 years of experience.
  • Strong understanding of in vitro diagnostics 
  • Strong understanding of immunohistochemistry or immunology is preferred. 
  • Strong communication skills in verbal and written formats. 
  • Demonstrated experience in medical or scientific writing within the IVD, pharmaceutical, or medical device industries. 
  • Experience writing and reviewing scientific literature reviews. 
  • Exceptional proof-reading skills with strong attention to detail. 
  • Able to work as part of a team with strong cross-functional and collaborative skills. 
  • Able to meet deadlines and complete work with minimal supervision. 
  • Proficiency in Microsoft Office Suite and document authoring tools, as well as experience in document management systems.

Expected Location & Hours of Work

  • 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.

Compensation Range

  • $90,000 - $102,000 annually

Full-Time Positions Offer

  • Company Sponsored Health Insurance - medical, dental, vision,
  • Company Sponsored Life Insurance
  • Voluntary Benefits
  • Retirement plan - 401(k)
  • PTO
  • Paid Holidays

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

Proof of at least one FDA EUA approved Vaccination for Covid-19 preferred. (Subject to reasonable accommodation)

All inquiries strictly confidential.

More Information on Biocare Medical, LLC
Biocare Medical, LLC operates in the Biotech industry. The company is located in Pacheco, CA. Biocare Medical, LLC was founded in 1997. It has 236 total employees. To see all 8 open jobs at Biocare Medical, LLC, click here.
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