Associate Director, Global Medical Affairs Operations

Location
Basking Ridge, NJ
Posted
Oct 04, 2021
Ref
R25
Hotbed
Pharm Country
Required Education
Associate Degree
Position Type
Full time

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.

Summary


Support Global Medical Affairs (GMA) in driving medical compliance standards for business implementation across all key GMA Oncology activities, in close collaboration with cross-functional and regional stakeholders. Contribute to the development and execution of a GMA Risk Management Plan (RMP) process and Audit & Inspection Plan process. Contribute and drive the operational execution of the document Life Cycle Management (LCM) process for Medical Affairs (MA) activities. Ensure GMA mandatory Learning Management System (LMS) training is assigned appropriately, new GMA associates are provided onboarding guidance and that GMA records are tracked according to expectations and internal SharePoint is maintained.

Responsibilities

  • Risk Management Plan (RMP):

    Contribute to the development of a systematic GMA RMP process to identify, evaluate, prioritize, mitigate and monitor risks and/or audit findings in partnership with QA and relevant stakeholders across functions, geographies and levels of the organization

    In partnership with key stakeholders, support with ensuring proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized GMA RMP process

    Drive the operational execution of the GMA RMP process and support with preparing and/or facilitating regular GMA RMP meetings, as applicable

  • Audit & Inspection Plan:

    Contribute to the development of a GMA Audit & Inspection Plan in partnership with QA and relevant stakeholders across functions, geographies and levels of the organization

    In partnership with other key stakeholders, ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by helping to build and maintain a repeatable and standardized GMA Audit & Inspection process

    Support with directing activities to help GMA team during preparation, conduct and closure of GMA Audits & Inspections

    In partnership with the relevant stakeholders, collaborate to develop strong remediation plans for Audit & Inspection findings and incorporate into the RMP Plan process

  • Document Life Cycle Management (LCM) Process:

    Contribute to the development of document Life Cycle Management (LCM) process for proposing, developing, reviewing, approving, training, distributing and archiving of global procedural documents for Global Medical Affairs (GMA) activities, as applicable

    Contribute to the development of LCM forms, templates, supplemental documents and deviations associated with LCM procedural documents for GMA activities, as applicable

    Drive the operational execution of the GMA LCM process and associated procedural documents for GMA activities in collaboration with Quality Assurance (QA), Global Research & Development Standard Operating Meeting Committee (GRDSOPC), GMA and other relevant stakeholders.

    Provide guidance to authors and ensure periodic review of MA procedural documents in alignment with the agreed upon LCM process

    Establish & implement GMA process for assignment in the Learning Management System (LMS) and tracking of required and supplemental trainings, in collaboration with QA
    Develop, maintain and oversee GMA specific curricula

  • Governance & Operational Excellence
    Establish and effectively maintain GMA Oncology SharePoint site
    Establish and maintain onboarding plans for new hires
    Serve as the Records Management responsible person for records management within GMA associates based in US

    • Facilitate the drafting/maintenance of the GMA Departmental Records Matrix, including document classification

    • Oversight of departmental records lifecycle – tracking documents from creation through archiving

    • Drive “Records Management Event Days” within GMA

    • Support record management training and education activities

    • Act as a point of contact for Legal Affairs with respect to the Record Management Plan and Legal Holds

    • Escalate issues, as appropriate


Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)Bachelor's Degree in science, Pharmacy, Medicines or Business Administration preferred

Experience Qualifications

  • Collaborative, team-oriented and results-focused with a strong global compliance mindset required

  • Good planning and project management skills required

  • Good verbal and written communication skills required

  • Experience in the pharmaceutical industry required

  • Ability to proactively identify and propose pragmatic solutions to address issues / risks required

  • Excellent analytical, interpersonal, and stakeholder management skills required

  • Ability to successfully interact with functionally-diverse stakeholders with associates at the global, regional and local level across cultures required

  • Proactive team player with an ability to act in a forward-thinking manner required

  • Knowledge and/or experience in medical affairs strongly preferred preferred

  • Track record of operational oversight & governance effectiveness in a matrix environment preferred

Travel - Ability to travel up to 5% Standard office based physical demands, some travel 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.