Associate Director, Medical Writing - 617550

Planet Pharma's client is looking for an Associate Director / Senior Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions 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 documents. This individual will support the overall strategy for all medical writing processes according standards.

Key Accountabilities/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 activites for a particular project
• Establishes operational objectives, policies, procedures, and job aids
• Executes corporate objectives, goals, measues, 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
• Bachelor’s degree in a scientific or clinical discipline or related field or equivalent experience required; PhD preferred