Director of Informed Consent Medical Writing

3 weeks ago

New York, New York, United States Merck Full time
Job Description

The Medical Writing Department at Merck is seeking a highly skilled and experienced Director of Informed Consent Medical Writing to join our team. As a key member of our department, you will be responsible for the development and management of informed consent deliverables that support our clinical regulatory writing portfolio while ensuring compliance with internal policy and procedures, regulatory requirements, and health literacy principles.

Key Responsibilities
  • Develop and manage informed consent deliverables for clinical trials across various therapeutic areas.
  • Oversee the work of other informed consent medical writers, providing scientific and operational mentorship and coaching.
  • Execute functional business plans and contribute to the development of the ICMW group and the department's objectives.
  • Contribute to department management through strategic input, continual process improvement, innovation, and collaboration with internal and external stakeholders.
  • Serve as a subject matter expert and represent the company regarding 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.
  • Lead, coach, and develop staff, and manage priorities and employee performance and development.
Requirements
  • 10+ years of pharmaceutical and/or clinical drug development experience.
  • Organization leadership and people management experience.
  • Expert knowledge and understanding of informed consent guidance and regulation, end-to-end drug development, and clinical trial processes.
Preferred Qualifications
  • Demonstrated ability to drive and manage 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.
  • Advanced understanding of end-to-end clinical research process.
  • Demonstrated leadership skills in managing people, programs, and processes.
  • Advanced problem-solving, conflict resolution, and critical thinking skills.
  • Expert knowledge of GCP and ICH regulations and corporate policies.
What We Offer

Merck offers a competitive salary range of $164,800.00 - $259,400.00, bonus eligibility, long-term incentive, health care and other insurance benefits, retirement benefits, paid holidays, vacation, and sick days. We are an Equal Opportunity Employer and welcome qualified applicants from diverse backgrounds.

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