Senior Medical Writer

Location
Basel area
Salary
Competitive
Posted
10 Jan 2019
Closes
06 Mar 2019
Ref
896129-P
Contract Type
Permanent

Main Responsibilities:

  • Write and manage review and approval of clinical and regulatory documents, such as clinical study reports (CSRs) and high-level clinical summaries and overviews;
  • Contribute scientifically and strategically at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing, e.g. provide input on pooling strategy, provide content expertise and guidance, and advise regarding regulatory requirements and ICH guidance;
  • Contribute to the planning of data analyses and presentation for CSRs and submission documents; review statistical analysis plans;
  • As required, support writing of responses to health authority questions;
  • Work together with the in-house Editorial Group to produce high-quality documents in compliance with internal company standards and external regulatory requirements;
  • Participate in process and technology improvement initiatives related to regulatory writing and documentation;
  • Manage the work of external medical writers, as needed;
  • Mentor/train less experienced writers.

Qualifications and Experience:

  • University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable;
  • English mother tongue, or excellent spoken and written English;
  • 5+ years of experience in writing regulatory documents;
  • Well-developed and proven medical writing skills, combined with an ability to interpret and present complex scientific data from different disciplines in a clear, concise format;
  • Proven global regulatory submission experience;
  • Excellent knowledge of global regulatory environment, including key document requirements, reporting guidelines and approval processes;
  • Strong ability to work under pressure and prioritize multiple deadlines and projects;
  • Ability to work independently and as part of a team;
  • Attention to detailExcellent interpersonal and communication skills;  
  • Relevant working/residency permit or Swiss/EU-Citizenship required.