Director, Informed Consent Medical Writer

October 7

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MSD

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10,000+

Description

• The Medical Writing & Disclosure Department prepares regulated documentation in support of clinical development portfolio • The Director, Informed Consent Medical Writer is responsible for the development and management of informed consent deliverables • Produce high-quality and timely documentation in line with health literate clinical trial informed consents for various studies • Oversee work of other informed consent medical writers, providing mentorship and coaching • Execute functional business plans and contribute to the development of the ICMW group • Serve as a subject matter expert and represent the company regarding informed consent regulatory intelligence • Provide strategic direction for informed consent processes and technologies to ensure compliance

Requirements

• BS/BA in health-related, life science or analytical related field • 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 • 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

Benefits

• bonus eligibility • long term incentive if applicable • health care and other insurance benefits (for employee and family) • retirement benefits • paid holidays • vacation • sick days