Expert Regulatory Writer
GDO GDD
Basel, Switzerland
vor 22 Tg.

Job Description

The Expert Regulatory Writer writes, reviews and / or manages high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications.

She / he provides leadership for Regulatory Writing and Submissions (RWS) within submission teams and authoritative document-

related consultancy to RWS and other line units.

Responsibilities :

  • Act as a member of clinical trial teams and submission teams and autonomously write / edit clinical study reports, CTD summary and overview documents, and other regulatory documents.
  • Provide strategic, authoritative leadership to other line units and within RWS with respect to regulatory submissions documents and other document-related issues.
  • Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
  • Lead Writer for submissions, contributing to key messaging and pooling strategy, providing content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
  • Write / edit other strategic documents, as required, e.g. responses to health authority questions, briefing books, pediatric investigation plans, etc.
  • Participate in planning of analysis and data presentation to be used in clinical programs, individual study reports and summary documents
  • Lead process improvement in RWS and / or cross-functional initiatives or activities (e.g., review of SOPs, templates).
  • Act as mentor to medical writers working on complex documents.
  • Leader in cross-functional communication to optimize feedback and input towards high quality documents.
  • Maintain audit, SOP and training compliance.
  • Minimum requirements

  • Minimum university life science degree or equivalent is required. Advanced degree or equivalent education / degree in life sciences / healthcare is desirable.
  • 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus extensive knowledge of medical writing processes.
  • Excellent communication skills (written, verbal, presentations).
  • Excellent understanding of biostatistics principles.
  • Expert data interpretation and presentation skills.
  • Strong ability to prioritize and manage multiple demands and projects.
  • Expert knowledge of global regulatory processes (key regulatory bodies, key documents, approval processes, safety reporting requirements) and clinical development.
  • Good influencing and negotiating skills
  • Ability to lead and mentor a cross-function team.
  • Ability to mentor / coach people
  • Experience of process improvement initiatives.
  • Fluent English (oral and written)
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