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'Associate Director, GCO Procedural Ownership and Life Cycle Management

Employer
Daiichi Sankyo
Location
Remote by Design Home Office
Start date
Jun 15, 2024

Job Details

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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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

The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be accountable for the authoring and lifecycle management of all GCO-owned procedural document packages, ensuring they are clearly and effectively written and maintained, are in alignment with other DS processes, guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of GCO's CRO SOP review and maintaining the master Daiichi Sankyo (DS) SOP list for CRO's.

Responsibilities:

DS Procedural Life Cycle Management:

  • Responsible for the ownership and maintenance of GCO-owned procedural document packages.
  • Lead authoring, review, and periodic reviews/updates for all GCO procedural packages and associated documents (including process maps) through cross-functional review cycles.
  • Establish standard end-to-end review cycle timelines and engage in stakeholder management activities to ensure timelines are met.
  • Hold comment resolution meetings, as needed.
  • Partner with CQM to develop a strategy to help address facilitation of risk-based periodic review/update cycles specifically for identified high-risk GCO procedures.
  • As needed, create and communicate lessons learned for life cycle management activities.
  • Keep GCO GSOPC Functional Member and other relevant SOP committees informed of new GCO procedural document packages and/or updates to existing GCO procedural document packages.
  • As needed, monitor 1) procedural compliance metrics to support inspection readiness activities, and 2) procedural deviations to identify potential gaps/deficiencies, potentially leading to an update in a procedural document package.
  • As appropriate, provide support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a new procedural document and/or procedural document package or any needed procedural document and/or procedural document package update(s).

Cross-Functional Procedural Management Related to Vendor Alliance and Oversight:

  • As needed, partner with Alliance Management for CRO- specific support, or Functional Excellence for any training-specific support which they oversee.
  • Master DS SOP List creation and management.
  • Responsible for managing the process for the creation and maintenance of the cross-functional Master DS SOP List our CROs must follow for all functional area work CROs are performing on our behalf (outsourced).Initiates functional area review of the master DS SOP list every 6 months and updates curriculum, as appropriate.
  • Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum in the LMS, as appropriate.
  • In collaboration with the DS Alliance Manager, confirm the CRO’s ability to download the DS SOPs into their training system.

CRO Procedural Review and Management:

  • Responsible for the review/approval management, and documentation of the Daiichi cross-functional review of CRO SOPs (initial, new SOPs, new version of SOPs), collaborating with Alliance Management, as needed.
  • Provide DS functional area curriculum owners with approved SOP list and access to the CRO procedures and/or updated or new procedures.

Other Support:

Provide input/support for GCO metrics (CTBO, SVO, etc.), as needed

Provide audit and/or inspection support, as needed

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 with minimum of 8 years’ pharmaceutical or biotechnology experience in one or more key functions (e.g. clinical operations, clinical research, clinical science, and/or CQA). Strong experience in procedural writing and maintenance, process improvement, and project management a plus. required Experience Qualifications
  • 7 or More Years Strong experience and expertise in end-to-end clinical operations functional understanding and execution required
  • Strong experience in procedural writing and life cycle management required
  • Additional clinical trial process experience in one or more key functional areas (e.g. clinical research & development, clinical science, clinical quality assurance, project management) preferred
  • Strong leadership, collaboration, influencing, and change management skills in a complex, matrix environment including team leadership or project management required
  • Additional experience in process improvement activities and implementation preferred
  • Experience with process mapping tools (e.g., Visio, Power Point), and Veeva Quality Docs required
  • Understanding of regulatory and industry guidance and updates, with ability to apply them to procedural updates, as appropriate preferred

Travel:

  • Ability to travel up to 10% For team/global meetings and/or external conferences, as appropriate.

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.

Company

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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Company info
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States

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