Medical Writer Ivdr - Signy, Schweiz - Haemonetics Corp.

Haemonetics Corp.
Haemonetics Corp.
Geprüftes Unternehmen
Signy, Schweiz

vor 1 Woche

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung
We are constantly looking to add to our core talent.

If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details


Haemonetics is looking for a self-driven, well-organized and diligent technical, scientific writer to join our team and work towards fulfilling on-going EU In Vitro Diagnostic Regulation (IVDR) requirements.

This position is responsible for the creation of scientific and regulatory documents while working with a cross-functional team in accordance with highest quality standards.


The Medical Writer also assists with writing and reviewing other regulatory documents related to IVDR and Post Market Performance Follow Up (PMPF) activities.


Responsibilities:


  • Creation and maintenance of regulatory documents related to clinical data of Haemonetics products (Performance Evaluation plans and reports) in liaison with other departments and in compliance with applicable regulatory requirements (EU IVDR, MDCG)
  • Advise on guidelines and standards relevant to Performance Evaluation
  • Plan and execute structured literature searches, identify and analyze relevant data
  • Work within a team to provide advice and consultative input as necessary for the Technical File
  • Plan and coordinate data generation and analysis activities both internally and externally
  • Alert to and consult the regulatory and quality teams on necessary revisions of relevant sections of the device labelling, as required

Qualifications/Experience:

  • BSc or equivalent in biological (desirable) or analytical discipline, advanced degree MSc/PhD highly desirable
  • 5 years (for advanced degree) to 10 years (for BSc) industry experience with at least 35 years of scientific writing experience in IVDs
  • Able to review qualitative and quantitative data
  • Exposure/understanding of the IVDR technical requirements
  • Experience of writing IVDR Performance Evaluation and clinical documents is a requirement
  • Advanced Statistical skills are a plus
  • Experience in working in matrix environment
  • English fluency (required), German (a plus)
  • EEO Policy Statement

Conditions of Employment:
Haemonetics's requires COVID-19 vaccination for all U.S.

employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law.

While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.

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