Senior Director, Medical Writing in Basking Ridge, NJ at DSI

Date Posted: 10/17/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

Responsible for leading the vision and strategy for the Medical Writing function and provide overall leadership to the function. Responsible for all medical writing activities within the scope of Medical Writing across the company portfolio. Sets the Medical Writing strategy for the function, submissions, and outsourcing while providing strategic support for other functions. Sets standards for medical writing related activities, processes, innovations, improvements and drives the implementation of such standards, Accountable for the function meeting high standards and producing high quality documents. Resolves conflicts, manages and influences stakeholders across all levels and globally, and builds important relationships to ensure the success of the function. Plans and assesses both internal and external resources. . This position has expertise in scientific knowledge and one or more therapeutics areas. This position will have people management responsibilities.

Responsibilities:

Sets the vision for the Medical Writing function, develops the functional strategy across all business portfolios and provides overall leadership to the function. Works globally across DS to support the function, strategy, and vision. Drives Medical Writing innovations and drives the use of global Medical Writing standards at DS. Collaborates and manages stakeholders (globally and regionally) to ensure success of strategy, vision, and mission of function. Serves as the head of Medical Writing and represents Medical Writing globally and regionally at DS. Closely collaborates with Regulatory Operations to inform of key deliverables (CSRs, Protocols, etc.) and partner together on process optimization activities that pertain to critical submission activities.

Sets medical writing strategy for global and regional submission summary modules and leads the strategic development of submissions (e.g., NDAs, SNDAs, BLAs) and related timelines.

Accountable for work delegated to CROs, sets the outsourcing strategy for Medical Writing and works with Outsourcing to recommend and select CROs; makes the final recommendation for CROs for Medical Writing.

Monitors performance of CRO organizations and external Medical Writers involved in DS Medical Writing work.

Provides strategic support and leadership to other functions such as Clinical, QCP, BDM, Regulatory Affairs Medical Affairs in all aspects of medical writing relevant to the other functions and fosters the visibility of Medical Writing across all functions of DSI.

Sets standards for medical writing-related activities, processes, innovations, and improvement dimensions. Sets and drives implementation of these standards.

Provides necessary guidance and training to other functions related to Medical Writing activities.

Resolves complex, cross-functional conflicts across the organization as pertinent to the Medical Writing function.

Plans and assesses resources and resource needs across all therapeutic areas and across the portfolio, assesses needs based on current and future workload and project priorities. Responsible for efficient and responsible use of resources. Foresees future business needs and plans for changes. Foresees training and development needs. Establishes and maintains the Medical Writing resourcing plan and budget in accordance to portfolio and business needs.

Manages direct reports and/or mentors colleagues. Provides direct reports and colleagues with guidance, training, and tools to develop professionally at DS in order to benefit the business and enhance retention
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • 10+ years of experience with a Master of Science degree; MD or PhD preferred
  • Experience leading submissions required
  • Previous experience leading and managing a medical writing group required
  • People management experience required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.