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Sr. Manager, Planisware Process & Data Standards Lead

Princeton, New Jersey

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Planisware Process & Data Standards Lead is responsible for driving strategic governance, business process standardization, and data integrity for the Planisware platform across Global Clinical Business Operations and R&D. This role leads functional governance through the FCAC (Functional Change Advisory Committee), oversees change control, and ensures consistent application of data governance practices, including master data management via the Planisware Data Dictionary. The position plays a central role in training, stakeholder engagement, backlog prioritization, and vendor coordination. Success in this role requires strong leadership in cross-functional process alignment, system development oversight, and a strategic mindset focused on quality, compliance, and user enablement.

Essential Functions:

Lead standardized process development and governance for Planisware.
Oversee change management and chair the FCAC.
Own data quality, data dictionary (MDM), and governance frameworks.
Drive cross-functional training and enablement strategies.
Coordinate system development priorities and manage third-party vendors.

Requirements:

Education
Bachelor’s degree in Life Sciences, Business Administration, Information Systems, or a related field is required.
An advanced degree (e.g., MBA, MS, or related graduate degree) is preferred.
Professional certifications in Project Management (e.g., PMP), Lean Six Sigma, Change Management (e.g., Prosci), or Data Governance are a strong plus.

Experience
Minimum 7 years of experience in clinical development, R&D operations, system governance, or data/process management within the pharmaceutical, biotech, or life sciences industry.
At least 3 years of hands-on experience with Planisware or similar enterprise projects and portfolio management (PPM) systems.
Proven experience leading process governance, change management, and data governance initiatives in a regulated (GxP/21 CFR Part 11) environment.
Strong track record in cross-functional collaboration, stakeholder engagement, and training/enablement activities for system adoption and process standardization.

Technical Skills
Strong knowledge of Planisware functionality, including configuration, business process mapping, and system governance.
Understanding of project and portfolio management (PPM) processes and tools, especially in clinical development and R&D environments.
Experience with User Requirements Specifications (URS) development and version control processes.
Familiarity with data governance principles, including master data management (MDM) and metadata standards.
Proficiency in interpreting and applying data dictionaries, business rules, and standardized data definitions across systems.
Working knowledge of change control processes, including functional change evaluation and documentation practices.
Experience with system validation, including knowledge of compliance standards such as 21 CFR Part 11, GxP, and audit readiness.
Competence in tools like JIRA, Confluence, or similar platforms for backlog, change tracking, and collaboration.

The anticipated salary for this position will be $155,000 to $ 170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

  • 401K with company matching
  • Discretionary Profit Sharing
  • Annual Bonus Program (Sales Bonus for Sales Jobs)
  • Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
  • Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
  • HSA & FSA Programs
  • Well-Being and Work/Life Programs
  • Long-Term Incentives
  • Life & Disability Insurance
  • Concierge Service
  • Pet Insurance
  • Tuition Assistance
  • Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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