Disclosure Analysts

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.

• Clinical trial data registration and results postings.
• Redaction operations and external data sharing.
• Authoring lay summaries and informed consent documents in alignment with global regulations and internal policies.
• Management of all external requests for clinical data.
• Periodic review of metrics and identification of process improvement needs.
• Leadership of a staff of up to 60+ medical writers and specialists, including approximately 10% flex staff.
• Participation in external engagement activities to align with regulatory changes and transparency practices.
• Point of contact for all external inquiries related to transparency policies and new guideline impact assessments.
• Collaboration with Legal and Communications to determine response strategy and communication methods.
• Strategic thinking and leadership in health literacy across the enterprise, including optimizing systematic integration.
• Partnering with legal and key stakeholders to update informed consent templates.
• Driving adoption of cultural competence, health literacy, and teach-back in clinical investigator training.
• Ensuring policies and procedures support 100% compliance with global disclosure requirements, data access, and voluntary company policies.
• Reviewing and approving local country disclosure SOPs to ensure alignment with FDAAA and Eudra
  
  CT processes.
• Developing strategies to maintain public data consistency across global registries and publications.
• Providing strategic direction for new processes and technologies to ensure compliance across global registries.

• Required:
  
  Bachelor’s Degree.
• Preferred:
  Master’s Degree or advanced education in a related field (Business, Public Health, or similar).

• 10+ years of biotech/pharmaceutical industry experience.
• Strong project management skills focused 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, Communications).
• Track record of innovation and leadership, developing and deploying strategic solutions with tangible results for policy, business, and diversity.
• Collaborator able 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.
• Success in leading complex, large-scale, cross‑functional, highly visible programs within a large health care organization.
• Excellent interpersonal, written and oral communication, presentation, organization, networking, and public relations skills.
• Strong communicator capable of articulating messages across the enterprise, including senior leaders.
• Significant experience working with oncology and vaccine confidence business areas.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other applicable legally protected characteristics.

• U.S. Hybrid Work Model: employees in office‑based positions in the U.S. will work a hybrid schedule of approximately three on‑site days per week and one remote day, with specific days varying by site.
• Salary range (U.S.): $ – $.
• Benefits include bonus eligibility, long‑term incentive (if applicable), health care and other insurance benefits for employees and families, retirement benefits, paid holidays, vacation, and sick days.
• Additional benefits: relocation assistance (none), visa sponsorship (none), travel requirements (10%).