Associate Director, Medical Writing

The Importance of the Role

As an integral part of the clinical team, the Associate Director, Medical Writing will independently plan, develop, and deliver high quality, strategically aligned clinical and regulatory documents. The Associate Director, Medical Writing is responsible for ensuring high quality with regard to scientific content, organization, clarity, accuracy, adequacy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes, and provides leadership and subject matter expertise and strategy for MW planning and coordination. The person in this role must be able to work effectively in a team environment and must have strong scientific, interpretive, organizational, and project management skills.

The Opportunity to Make a Difference

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents, including clinical protocols, clinical study reports, Investigator's brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, and regulatory responses.
• Provides product and platform writing and strategy support to cross-functional teams.
• Represent Medical Writing on project teams and advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
• Plays a critical role in the execution of MW documents, ensuring adherence to MW processes and compliance with applicable global regulations.
• Collaborates cross-functionally to drive best practices, implement lessons learned, and improve future capabilities to enhance the effectiveness of compliant clinical trial execution and "Real Time" Inspection Readiness.
• Ensures compliance within the company, maintains knowledge of regulations, product areas, current trends, and current literature.
• Creates and maintains SOP and other MW governance documents.
• Leads efforts to identify and solve for compliance or efficiency gaps in processes.
• Participates in meetings and activities to enhance cross functional alignment between electronic document, quality, and TMF systems management.
• Provides metrics on MW performance and takes action to assure alignment with corporate, department and functional goals.
• Member of the Global Regulatory Team, Clinical Trial Team, and other sub teams (as needed) for assigned products.
• Supports development, onboarding, and training for direct reports and MW team. Mentors colleagues as needed.
• Supports corporate objectives that have critical impact.
• Strives for alignment with organizational business objectives both within GRA and cross-functionally.
• Escalates and effectively communicates issues to supervisor and other related MW stakeholders.

More about You

• Bachelor's degree or equivalent; life sciences is preferred.
• 10+ years of relevant experience, with 8+ years of medical writing or other writing experience.
• Excellent writing skills.
• Ability to understand, interpret, and communicate clinical and scientific data.
• Knowledge of drug development process is essential, as well as knowledge of current regulatory requirements and guidelines applicable to GCP/ICH/eCTD compliant documents.
• Previous experience with NDAs/BLAs with active contribution in preparation and writing of clinical and regulatory documents is required.
• Proven ability to multitask, deal with competing priorities, and meet aggressive timeline expectations.
• Experience and success in working with cross-functional teams.
• Excellent interpersonal and communication skills.
• Proven flexibility/adaptability to work in a fast-paced and dynamic environment.
• Knowledge and application of Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and guidelines ALCOA+ standard.
• Approachable with track record for building excellent constructive, positive, collaborative relationships.
• Demonstrated project management experience.
• Advanced proficiency in MS Office Suite and ability to quickly learn new electronic applications.