HireDiversity

Titusville, NJ, US

Global Head of Regulatory Medical Writing-000006VE

Description

Janssen Research & Development, LLC, a member of the J&J Family of Companies is recruiting for a Global Head of Regulatory Medical Writing to be based in Raritan, Titusville, NJ, Spring House, PA, or Beerse, BE.

The Global Head of Regulatory Medical Writing (RegMW) has overall responsibility for the mission and vision of the RegMW CoE including scientific excellence, productivity, effectiveness, people leadership strategy, resourcing strategy, costing/sourcing models, benchmarking, and global visibility of the CoE contribution to the body of clinical and scientific knowledge as part of the product lifecycle.

This position makes decisions that directly impact the strategic direction and effectiveness of the overall RegMW organization. This position is charged with making policy decisions that impact the strategy as it affects other functions, therapeutic areas, and business units; Will have impact on overall staffing strategy, assignments, and budget; Influences and makes decisions that will have an impact on people development and resource management across all areas, in addition to departmental guidelines, standards, processes, resourcing and innovations. The Global Head of Regulatory Medical Writing will be an active member of the RegMW and Biostatistics & Programming (B&P) leadership team and as such contribute to the overall strategy aligned with the R&D Operations leadership strategy.

This position has oversight of all departmental/CoE work streams and initiatives related to standards, process improvement, or other key department or cross-company activity. The Global Head represents RegMW in interactions with the overall organization. Decisions have short-term (up to 1 year) and long-term (up to 5 years or greater) implications. Experience leading and managing people and a large organization are essential. This position also requires expert scientific knowledge, including the therapeutic area(s) and individual product knowledge. This position requires experience with documentation standards, project management tools and theory, strategic processes, internal and external regulatory guidance, information technology, and relevant budgeting practices. Experience navigating and influencing throughout the global organization and culture is essential.

S (He) will provide clear direction and holds direct and indirect reports accountable for results, including alignment across the R&D Operations as needed. This position leads the development of a long-term people strategy on engagement, development, and retention and is accountable for executing the plan in the department. This position ensures alignment with the overall organizational strategy in processes such as performance management, compensation, and succession planning.

The successful candidate will lead the development and implementation of the strategy in resourcing and organizational structure, leads the strategy for external and internal partnerships and takes a leadership role for complex human resources situations. S (He) will manage medical writers and technical support staff in the preparation of clinical documents, is responsible for performance oversight and development, as well as accountability and performs people management tasks such as performance management, compensation, and succession planning. Will foster an environment and holds staff accountable for leadership (both people and personal) and performance development of their direct reports. Mentors other people managers.

This person is responsible across the function for ensuring that RegMW leaders are overseeing deliverables of high scientific integrity that meet company goals. Provides overall oversight for CoE in terms of ensuring content and scientific quality of deliverables; Provides overall oversight for ensuring consistency of strategy across all functional units in RegMW.

Qualifications


A PhD or equivalent in one of the biological sciences with 15 years of relevant pharmaceutical/scientific experience, or an MS or other advanced degree with at least 16-18 years relevant pharmaceutical/scientific experience is required. At least eight years medical writing and relevant technical experience is required. A minimum of eight years of prior people management experience is required, including managing (or having the ability to manage) a large group in multiple global locations. Experience leading complex cross-functional global projects, collaborating on complex scientific concepts, leading projects across therapeutic areas and indications and broad experience dealing with external service providers, preferably in different regions and cultures. Expert scientific knowledge, including the therapeutic area(s) and individual product knowledge and the ability to navigate and influence throughout the global organization and culture is required. Approximately 25% travel (domestic and global). Must be fluent (both oral and written) in English.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Titusville
Other Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Research & Development, LLC. (6084)
Travel:Yes, 25% of the time
Job Function: Medical Writing