Job Description
The Medical Writing & Disclosure 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 Director, Informed Consent Medical Writer (ICMW) is responsible for the development and management of informed consent deliverables that support the clinical regulatory writing portfolio while ensuring compliance with internal policy and procedures, regulatory requirements, and health literacy principles.
The responsibilities of the Director ICMW are to:
- Produce high-quality and timely documentation in line with health literate clinical trial informed consents for studies of varying complexity across therapeutic areas.
- Oversee work of other informed consent medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments while promoting an audit ready environment.
- Execute functional business plans and contribute to the development of the ICMW group and the department’s objectives by engaging strategically with key stakeholders across department, division, and company. Role requires proactive partnering, strategic thinking, and leadership to envision, plan, and execute operational projects.
- Contribute to department management through strategic input, continual process improvement, innovation, collaboration with internal and external stakeholders, and leadership for ICMW processes, standards, and initiatives.
- Serve as a subject matter expert and represent the company regarding insight into informed consent regulatory intelligence, health literacy and industry trends to assess and strategize business activities impacted by new or modified requirements through external partnerships, collaborations, and key strategic engagements.
- Provides strategic direction for informed consent processes and technologies to ensure compliance with International Council on Harmonisation (ICH) Good Clinical Practice and regulatory guidance pertaining to Informed Consent.
- Lead, coach and develop staff and manage priorities and employee performance and development in alignment with business needs and staff developmental opportunities.
Qualifications
BS/BA in health-related, life science or analytical related field.
Required Experience:
- 10+ years pharmaceutical and/or clinical drug development experience.
- Organization leadership (e.g., program management) and people management experience.
- Expert knowledge and understanding of informed consent guidance and regulation, end-to-end drug development and clinical trial processes.
Required Skills:
- Demonstrated ability to drive and manage highly complex topics related to informed consent activities.
- Strong decision-making and analytical skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
- Strong people management skills to enable resource management and development management of direct reports.
- Possess advanced understanding of end-to-end clinical research process.
- Demonstrated leadership skills in managing people, programs & processes, leading meetings and influencing matrix environments.
- Advanced problem solving, conflict resolution, and critical thinking skills.
- Expert knowledge of GCP and ICH regulations and corporate policies.
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