Director, GMA Oncology Governance & Operational Excellence in Basking Ridge, NJ at DSI

Date Posted: 3/12/2020

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:

Drive medical compliance standards for business implementation across all key Global Medical Affairs (GMA) activities, in close collaboration with cross-functional and regional stakeholders. Develop and ensure execution of an effective and efficient GMA Risk Management Plan (RMP) and Audit & Inspection Plan process. Assess compliance risks and operational gaps, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across functions, geographies and levels of the organization.

Responsibilities:

Risk Management Plan (RMP):

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

Ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized GMA RMP process

Prepare and facilitate regular GMA RMP meetings to ensure appropriate communication, involvement, resource assignment negotiation and buy-in with relevant stakeholders

Help drive the operational execution of the GMA RMP process and proactively manage GMA RMP resource model and timelines

Audit & Inspection Plan:

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

Ensure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized GMA Audit & Inspection process

Prepare and facilitate regular GMA Audit & Inspection meetings to ensure appropriate communication, involvement, and buy-in with relevant stakeholders

Ensure and oversee strong remediation plans for GMA Audit & Inspection findings and incorporate into the GMA RMP

Lead and/or direct activities to support GMA team during preparation, conduct and closure of GMA Audits & Inspections in partnership with relevant stakeholders

Governance & Operational Excellence

Contribute to the development and support with operational execution of a sustainable document Life Cycle Management (LCM) process for proposing, developing, reviewing, approving, training, distributing and archiving of global procedural documents for Medical Affairs (MA) activities, as applicable

Support the GMA process for assignment and tracking of required and supplemental trainings in the Learning Management System (LMS)
Establish & maintain effective communication channels to raise awareness of GMA compliance-related matters across MA

Coach or mentor team members

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

Education/Experience:

Qualified candidates must have a Bachelor's degree from an accredited college or university in Science, Pharmacy, Medicines, Business Administration or relevant field.

10+ years of experience in pharma at local, regional and/or global level preferred

Excellent verbal and written communication skills
Strong knowledge on operational aspects of medical affairs activities
Knowledge and/or experience in leading medical affairs oversight & governance activities preferred
Awareness of external trends and changes in regulation in order to proactively adjust internal processes
Ability to facilitate and influence decision making to drive results
Proven ability to drive pragmatic solutions to complex problems
Strong change management skills to drive and sustain a culture of high ethical standards and compliance

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.