Associate Director of Regulatory Medical Writing
1 month ago
Planet Pharma's biopharma client is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department.
This individual will contribute to and execute the overall strategy for all medical writing processes to according medical writing standards standards and corporate objectives.
Roles and 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-organized, 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
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 summarize data to provide conclusions
- Ability to work precisely according to procedures and regulations
- Excellent written and verbal communication skills
- Ability to prioritize 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
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