Head of Oncology Medical Writing (Rahway, NJ, Upper Gwynedd, PA or Boston, MA)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Head of Oncology Medical Writing, with both a people and project-facing orientation, will be responsible for leadership and management of oncology medical writers. In this role the Head will:
- Execute functional business plans of the clinical regulatory writing portfolio and contribute to the development of the group and the department’s objectives.
- Manage priorities and assign internal and external medical writing resources, in alignment with business needs and staff developmental opportunities. Provide scientific and operational guidance to medical writers, ensuring consistent application of standards and adherence to regulatory requirements and the timely completion of high quality deliverables.
- Serve as a primary subject matter expert to therapeutic areas for the planning, design, and preparation of clinical documentation.
- Build and foster a medical writing group capable of providing the expertise, organization, operations, capabilities, and behaviors required to deliver success on projects.
- Hire appropriate, qualified staff (internal and through functional service providers).
- Manage employee performance and development.
- Coach and mentor team members.
- Contribute to department management through strategic input, continual process improvement, innovation, collaboration with internal and external stakeholders, and leadership for medical writing processes, standards, and initiatives.
- Participate in budgeting, administration, and business objectives for their group.
- Bachelor’s degree, graduate level education preferred (see below). Academic preparation in life sciences or pharmacy preferred.
- Doctoral degree & 6 years of regulatory medical writing experience OR Master’s degree & 10 years of regulatory medical writing experience OR Bachelor’s degree & 12 years of regulatory medical writing experience AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
- Prefer 10+ years of related experience in the pharmaceutical/biotechnology industry in a matrix organization. Experience in oncology clinical trials strongly preferred.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Clinical Research - Clin Ops
Other Locations: Boston, MA, US; Upper Gwynedd, PA, US
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 2
Shift (if applicable):
Company Trade Name: Merck