The Senior Medical Writer will be based in Belgium (Permanent position) and have the opportunity to support the company, a clinical-stage bio-pharmaceutical company, with the production and development of innovative therapies.
Key Responsibilities:
- Support the indication or project lead writer in developing content for, writing, and editing a variety of clinical-stage documents
- Draft and manage documents that are well-organised, accurate, consistent, and compliant with applicable company style guide, SOPs, and Health Authority regulations
- Facilitates standardisation of clinical documents using document templates, lexicons, and company style guide to ensure the quality and consistency of documentation across programs
- Collaborate with the lead writer and clinical/safety/regulatory project teams, including the program leader, clinical study managers, bio-statisticians, and medical directors, to ensure project deadlines are met by providing content development support, research, and editing functions for each program
- Responsible for inspection-readiness of medical writing activities
- Executes corporate objectives, goals, measures, and strategies
Desired Skills and Experience:
- Bachelor's degree in a scientific or clinical discipline or related field required; PhD preferred
- Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
- Native/bilingual or fluent American English proficiency
- Familiarity with FDA and ICH guidelines for regulatory reporting
- Experience with Veeva vault and Please Review preferred
- Experience writing for biologics preferred
- Basic understanding of scientific methodology, with the ability to understand clinical development and eCTD structure, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
- Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
- Ability to proofread documents for compliance with internal and external guidance documents
- Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
- Ability to work precisely according to procedures and regulations
- Excellent written and verbal communication skills
- Ability to prioritise and multi-task successfully in a fast-paced environment
- Ability to work autonomously, as well as in a team
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- Must be proficient in MS Office
