Senior Medical Writer - Belgium
Home based role - need to be based in Belgium. Occasional travel to Brussels once or twice per month
12 month freelance contract
Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices.
Demonstrates subject matter and therapeutic area expertise.
Effectively manages medical writing projects to deliver quality products in agreed timelines.
Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Independently researches, writes, and edits clinical study reports, study
protocols and standard response documents.
Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers.
Provides senior review of documents and training/mentoring for other
Manages all aspects of planning, organizing, and executing projects without
supervision including: developing project timelines, standards, budgets,
forecasts, and contract modifications.
Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory).
Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
May manage several long-term projects concurrently.
Represents Medical Writing in Project Launch Meetings, Review meetings, client
audits, bid defenses, and capabilities presentations.
Establishes and develops client relationships; independently initiates and leads
interactions with clients.
Assists with business development and development of budgets and proposals.
Education and Experience:
- Must have breadth of regulatory writing experience (including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, and other key clinical and regulatory submission documents)
- Bachelor's degree in a scientific, medical or clinical discipline or related field required, PhD preferred
- Minimum of 5-7 years of pharmaceutical/biotechnology related medical writing experience required