Merck Director, Informed Consent Medical Writer Augusta, Maine Apply Now
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.
Responsibilities:
- 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.
- 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.
- Provide strategic direction for informed consent processes and technologies to ensure compliance with 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.
- 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.
- Advanced problem solving, conflict resolution, and critical thinking skills.
- Expert knowledge of GCP and ICH regulations and corporate policies.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Remote
Job Posting End Date: 10/22/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.
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