• Permanent
  • Suisse Romande
  • Recruiter: Karolina Frank

The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Medical Writer

Our client, a global provider of blood and plasma supplies and services, is looking for a Medical Writer. This is a permanent role based in Vaud, Switzerland (can be anywhere in Switzerland but with a need to come in the office from time to time – to be defined with the candidate).

You need to be already based in Switzerland or willing to relocate to Switzerland.

This position is responsible for the creation of scientific and regulatory documents while working with a cross-functional team in accordance with the highest quality standards. The Medical Writer is responsible for performing, preparing, and maintaining Clinical Evaluation Reports for CE technical documentation in accordance with the requirements of the EU Medical Device Regulations (MDR) and related guidance documents (e.g. MEDDEV.2.7./1 Rev. 4). This involves analyzing available safety and performance data for medical devices and preparing clinical data documents that support regulatory submissions for the EU, US, and other international markets.

The Medical Writer also assists with writing and reviewing regulatory documents related to the preparation, conduct and reporting of clinical investigations and other PMCF activities.

Responsibilities: 

  • Creation and maintenance of regulatory documents related to clinical data of the client’s products (CER, SSCP, PMCF, CRBA) in liaison with other departments
  • Plan and execute structured literature searches, identify and analyze relevant clinical data
  • Write Clinical Evaluation plans and reports in compliance with applicable regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG)
  • Write study protocols, safety plans and reports in liaison with Medical and Regulatory Affairs
  • Support Medical Affairs and Regulatory Affairs in development and execution of regulatory strategies
  • Manage vendors; Plan and coordinate vendor activities
  • Manage temporary worker staff (1-2 people over time)

Qualifications: 

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor or Master of Science (required) or higher graduate degree (preferred)
  • 3-4 years of experience in in the medical device/pharmaceutical industry and in medical/scientific writing
  • Hands on experience in writing multiple CER’s and be able to speak out for the scientific affairs team and interact efficiently with cross functional teams.
  • Manage numerous external vendors and contingent workers (supervisory role)
  • Clear, concise scientific style of writing; attention to detail to provide high-quality results
  • Affinity to scientific literature and data analyses using state-of-art information technology
  • Basic knowledge of biostatistics and medical background/application of the client’s products
  • Organized and self-driven; project management skills to manage multi-product writing portfolio
  • Excellent English language skills, German or other EU language is a plus

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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