The Associate Director 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:
- Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
- Author clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organised, consistent, accurate, and that complies with applicable company SOPs, style guide, lexicon, templates, and libraries
- May include roles that are key technical or subject matter experts providing professional or thought leadership.
- Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectives.
- Collaborates with clinical project teams, including program leader, clinical study managers, biostatisticians, medical directors, to ensure project deadlines are met
- Responsible for inspection-readiness of medical writing activities
- Responsible for medical writers assigned to support the medical writing activities for a particular project
- Establishes operational objectives, policies, procedures, and job aids
- Executes corporate objectives, goals, measures, and strategies; and begins to inform the development of them
- May delegate work assessments p
Desired Skills and Experience:
- Bachelor's degree in a scientific or clinical discipline or related field required; PhD preferred
- Minimum of 5 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 clinical reporting
- Familiarity with pharmacovigilance documents preferred
- eCTD development, publishing, and submission experience preferred
- Therapeutic experience in biologics preferred
- Basic understanding of scientific methodology, with ability to understand clinical development, 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 summarise data to provide conclusions
- 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 collaboratively 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
