Senior Medical Writer

Location
Netherlands
Salary
Negotiable
Posted
01 Jun 2021
Closes
01 Jul 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Medical Writer/Sr. Medical Writer

The (Senior) Medical Writer is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.

Responsibilities:

  • Provide regulatory writing expertise, leadership, project management, and strategic input for multiple compounds and/or projects within a therapeutic area as part of the preparation of the regulatory documents
  • Ensure delivery of high-quality submission-ready documents for incorporation into the final submission
  • Serve as the Medical Writing Lead on regulatory documents, including drafting the document using existing relevant sources as well as information and direction that are provided by the team
  • Finalize clinical protocols/amendments, investigator’s brochures, clinical study reports, PSUR, DSUR, and sections of IND/NDA submission documents
  • Communicate and track deliverables needed, writing process, and timelines to team members
  • Interface with internal and external groups to ensure accurate and timely completion/delivery of information to be submitted
  • Ensure documents produced are of the highest quality and completed per timelines and are compliant with SOPs, ICH/GCP/regulatory guidelines and company goals.
  • Coordinate and prioritize multiple project deadlines in a fast-paced environment.

Requirements / Qualifications:

  • Minimum of Bachelor’s degree in the life sciences; MSc or PhD preferred.
  • Minimum of 5 years’ clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment, with extensive experience independently writing and/or editing clinical protocols and protocol amendments, CSRs, CTD modules, regulatory briefing documents, and responses to competent authority queries.
  • Broad working knowledge of the clinical drug development process with experience integrating information from all phases of clinical development into clinical-regulatory documents / submissions.
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
  • Strong project management skills with a reputation for being detail oriented.
  • Proven ability to be an integrative, conceptual and analytical thinker.
  • Proven strong written and oral communication skills, with proven proficiency in English grammar and spelling.
  • Ability to manage complex projects with minimal supervision.
  • Ability to work well under pressure and adapt to change as needed.

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