Assoc Dir, US Med Affairs, Strategic Planning, Operations & Compliance in Basking Ridge, NJ at DSI

Date Posted: 6/19/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position is accountable for leading strategic planning and operations for the MI&E group as well as managing projects and initiatives within MI&E and collaboratively managing projects across US Medical Affairs. The Associate Director is responsible for overall MI&E budget/finance, contracts, and vendor procurement and management. This position is responsible for overseeing the development, maintenance and refinement of all US Medical Affairs policies and procedures, training management for all applicable company policies and procedures and supporting USMA in adhering to compliance standards in close collaboration with internal stakeholders.

Responsibilities:

Strategic Planning:
  • Refine processes for development, execution and monitoring of annual business plans for MI&E
  • Collaborate with MI&E Leadership to maintain and execute the annual business plans for MI&E
  • Champion the development and execution of launch plans, closely collaborating with staff in MI&E and across USMA
  • Support MI&E Leadership in ad hoc business planning and development
Operations:
  • Improve operational efficiencies and effectiveness
  • Troubleshoot and conduct gap analyses
  • Provide MI&E systems support and upgrades
  • Develop and implement work standards and best practices
  • Support USMA leadership by facilitating alignment across USMA, and implementing work standards/best practices for collaboration and communication with USBD functions and GMA, as assigned
  • Develop and generate standard MI&E reports/analytics and KPIs
  • Partner with other MI&E staff members to manage business operations
  • Manage/lead projects/initiatives within MI&E and across functions as assigned
  • Manage forecasting, budgets/finance,
  • Support planning and execution of departmental activities/meetings as assigned
Compliance:
  • Manage the development and maintenance of all USMA policies and procedures
  • Manage/maintain training plans for USMA on all applicable policies and procedures and drive timely completion of training
  • Collaborate with internal stakeholders to: establish framework and standard processes to ensure USMA activities are conducted compliantly; identify potential compliance risks; identify gaps between USMA operations and applicable policies, procedures, laws and regulations; rapidly develop and execute effective mitigation plans
  • Support USMA Leadership in assuring USMA compliance and developing best practices within and across USMA functions
  • Serve as a key liaison with Legal Affairs, Compliance, GMA and other departments as needed for the maintenance of policies and procedures and to champion USMA compliance
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • BA/BS degree required, MS; PharmD or PhD preferred
  • 7+ years of experience in Medical Affairs in an operations or compliance role
  • Strong decision-making and problem-solving skills
  • Proven ability to work effectively with external partners and internal colleagues across functions/divisions (US, Global, DSPD, Legal Affairs, Compliance etc.)
  • Self-motivated with proven ability to work independently with little direction
  • Customer Focus
  • Strong leadership skills, including ability to lead cross-functional team collaboration towards achieving objectives
  • Proven strategic planning and program/project management skills
  • Strong budget management & phasing skills
  • Strong communication (verbal and in written form) and presentation skills
  • Innovative and adept at thinking expansively
  • Managing competing demands and multi-tasking in a fast-paced environment
  • Experience in oversight of data systems requirements in order to meet the evolving needs of the MA business
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.