Medical Writer - In Vitro Diagnostics (IVD)

Agilent Technologies

  • Glostrup, Hovedstaden
  • Permanent
  • Fuldtid
  • 13 dage siden
Job DescriptionAgilent Technologies is seeking an experienced Medical Writer to join our Global Clinical Affairs team in Glostrup (Copenhagen), within the Organization of Chief Medical Officer (OCMO). This role plays a critical part in supporting our medical diagnostic portfolio, ensuring compliance with the EU In Vitro Diagnostic Regulation (IVDR) 2017/746.As a key contributor, you will be responsible for compiling and interpreting clinical performance data for all CE-marked products. Your work will support regulatory submissions and ongoing compliance efforts. You will collaborate closely with cross-functional teams including Research & Development, Quality Assurance, Regulatory Affairs, and other internal partners.Key Responsibilities:
  • Author Clinical Performance Reports for CE-marked products in compliance with IVDR (EU) 2017/746, as well as clinical research reports, abstracts, and publications
  • Support the preparation and maintenance of technical documentation for regulatory submissions and audits.
  • Conduct systematic literature searches to support IVDR documentation, post-market surveillance, and regulatory submissions.
  • Analyze and trend External Quality Assessment (EQA) performance data.
  • Research internal controlled documents and Instructions for Use (IFUs) for existing clinical performance data.
  • Collaborate with internal stakeholders to compile documentation required under EU IVDR.
  • Work with subject matter experts to ensure scientific accuracy and strategic alignment.
  • Contribute to clinical process development and author Standard Operating Procedures (SOPs).
QualificationsWe are looking for an experienced individual with the following background:
  • Master's degree or advanced degree in pharmaceutical, medical or relevant biomedical science fields.
  • 4+ years of experience in clinical research, medical writing, or clinical science in the medical device and/or pharmaceutical industry
  • Strong understanding of IVDR regulations, Good Clinical Practice (GCP) and regulatory documentation standards.
  • Ability to conduct and synthesize systematic literature reviews.
  • Excellent written communication skills with attention to scientific detail.
  • Ability to work independently and collaboratively in a cross-functional environment.
We offer:
  • Permanent Contract and Core global benefits, including the Agilent Result Bonus and Stock Purchase Plan.
  • An exciting workday with many challenges, where you have the opportunity to influence processes and the way we work.
  • An inspiring work environment with dedicated and competent colleagues - humor and smiles are part of everyday life!
  • A good balance between work and private life.
We will make sure you get all the training and development opportunities to become the best in your field!Additional DetailsThis job has a full time weekly schedule. It includes the option to work remotely.Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required: NoShift: DayDuration: No End DateJob Function: Medical/Clinical

Agilent Technologies