Job Description
The Medical Writing & Disclosure (MW&D) Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers.
The Executive Director in Medical Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations, external data sharing, and authoring lay summaries and informed consent in compliance with global regulations and company policies. Additionally, they will manage a large team of medical writers and specialists, engage in external activities to align the company with regulatory changes, act as the point of contact for external inquiries related to transparency, and provide strategic leadership in health literacy and compliance with global disclosure requirements.
Primary Responsibilities:
- Responsible for clinical trial data registration, results postings, redaction operations, external data sharing, authoring lay summaries and informed consent in alignment with global regulations and internal company policies.
- Manage all external requests for clinical data, including periodic review of metrics and identification of process improvement needs.
- Manage a staff of up to 60+ medical writers and specialists to complete all authoring, approval, and posting activities; Plain Language Summaries, Informed Consent, and redaction operations. Staffing model is ~10% flex staff.
- Participate in external engagement activities to align the company with changes to regulations and general transparency practices.
- Act as the point of contact for all external inquiries related to transparency policies, challenges to regulations, and impact assessments for new guidelines. Work closely with Legal and Communications to determine the need for response and the best method for communicating.
- Provide strategic thinking and leadership in health literacy across the enterprise.
- Assess ongoing health literacy activities across Research & Development (R&D), optimizing systematic integration.
- Partner with legal and key stakeholders to update informed consent templates.
- Drive adoption of cultural competence, health literacy, and teach-back in clinical investigator training.
- Ensure policies and procedures are in place to deliver on 100% compliance with global disclosure requirements, data access, and all voluntary company policies.
- Review and approve local country disclosure SOPs to ensure alignment with FDAAA and EudraCT process and data content.
- Develop strategies to maintain public data consistency across global registries and in publications.
- Provide strategic direction for new processes and technologies to ensure compliance across global registries.
Education:
- Required: Bachelor's Degree
- Preferred: Master's Degree or advanced education in a related field (Business, Public Health, or similar)
Required Experience and Skills:
- 10+ years biotech/pharmaceutical industry experience
- Project management skills; focus on quality and efficiency
- Understanding of global regulations for clinical trial disclosure activities
- People management skills; ability to manage workload across FTE and contractor staff
- Strong relationships with internal stakeholders (OCMO, Legal, Compliance, GRA, and Communications)
- Demonstrated track record of innovation and leadership, developing and deploying strategic solutions with tangible results for policy, business, and diversity
- Proven collaborator with the ability to work across functions and regions, accomplishing specific goals without direct authority
- Ability to inspire passion for health literacy and health equity, driving ownership across divisions and regions
- Proven success in leading complex, large-scale, cross-functional highly visible programs within a large health care organization setting
- Demonstrated excellent interpersonal, written and oral communication, presentation, organization, networking and public relations skills
- Strong communicator with the ability to clearly articulate messages/information across the enterprise, to all levels, including senior leaders
- Significant experience working with oncology and vaccine confidence business areas
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