Clinical Documentation Specialist

WorkplaceBasel, North West Switzerland, Switzerland


Clinical Documentation Specialist

Switzerland, Basel-Town, Basel

As a Clinical Documentation Specialist you will join the Oncology Early Development at the Roche Innovation Center Basel, Switzerland and interact closely with a team of clinical scientists and functional experts working on novel classes of cancer therapy agents. As an expert in scientific writing you will edit and proof read clinical documents, coordinate processes as well as support Clinical Expert Teams/Study Management teams:

  • Supports the development of high-quality clinical documents e.g. study protocols, amendment documents, informed consent forms, subject information leaflets etc.
  • Is accountable for Planning, creation and co-ordination of timelines for the production and review of clinical protocol-related documents ensuring alignment with overall project timelines.
  • Co-ordinates the clinical protocol-related documents draft and review process including generation of draft document from content provided by contributing authors; collection, adjudication, and incorporation of comments from team, cross-functional and functional reviewers; and resolution of issues/errors/inconsistencies with team members.
  • Edits and/or proof-reads pRED clinical protocols and related documents.
  • Is accountable to ensure consistency, accuracy and compliance with local and global guidelines.
  • Supports selection and management of appropriate templates within documentation system.
  • Is accountable to ensure documents are published and approved by the accountable signatory.
  • Provides support to technical review meetings such as DRC (minutes, etc)
  • Participates as needed as a member or ad-hoc participant of key functional/cross-functional teams (i.e., project team, clinical team, study management team) to ensure appropriate documentation guidance and support.
  • Collaborates with Regulatory Clinical Documentation Group to ensure consistency of submission documentation.

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You own a Bachelors degree or an equivalent advanced degree in life sciences (i.e., MS, PhD) or in any other relevant field.

Experience, Skills, Knowledge:

  • Demonstrated clear, high-quality scientific writing style in the English language.
  • Experience in early stage drug development is preferred.
  • Thorough understanding of multidisciplinary functions involved in early stage Drug Development Process is essential (e.g., Clinical Operations, Biostatistics, Regulatory, etc.).
  • Experience as a coordinating author and with providing editing and prof-reading support for clinical documents for various therapeutic areas and global programs is desirable. Experience with working on clinical documents in the field of oncology is a distinct plus.
  • Understanding of Federal Regulations and International standards as they pertain to reporting of clinical trials.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche’s largest sites. Read more .

Roche is an equal opportunity employer.

  • Location Switzerland, Basel-Town, Basel
  • Function Research
  • Subfunction Early Development/ Translational Medicin
  • Schedule Full-time
  • Job level Individual Contributor
  • Job type Regular Employee
  • Division Roche Pharmaceuticals
  • Posted since 2018/03/11
  • Posted until 2018/06/10
  • Job-ID 3450369618

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In your application, please refer to
and reference  JobID 39091.

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