The 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:
- Managing focus
- Manage (80%) 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 (20%) 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
AND
- Engage relevant SMEs and document owners to develop content that is well-organised, consistent, and accurate clinical content for regulatory submissions that complies with applicable company SOPs, style guide, lexicon, templates, and libraries
- Facilitates standardisation of clinical documents using document templates, company style guide, and applicable lexicons or libraries to ensure the quality and consistency of documentation across programs
- Collaborates with clinical project teams, including program leader, clinical study managers, biostatisticians, 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
- Mentors less experienced medical writers, and develops and implements training in support of medical writers and cross functional teams
- Contributes to the development of departmental strategy(ies)
- Participates in the development of corporate objectives, goals, measures, and strategies
- Ensures corporate objectives, goals, measures, and strategies are being executed by direct reports
- Directs activities of a multifunctional projects and reconciles multiple stakeholder views
- 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 medical writers assigned to support the medical writing activities for a particular project
- Resolves complex issues in which situational or data analyses requires in-depth evaluation of variable factors
- Determines methods and procedures on assignments
Desired Skills and Experience:
- Bachelor's degree in a scientific or clinical discipline or related field required; PhD preferred
- Minimum of 7 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
- Can provide solutions in creative, effective, and constructive ways
- Understands the interrelationships of various disciplines within the organisation and can effectively navigate
- Experience in leading teams
- Managed direct reports or contract medical writers
- 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 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 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
