10 дней назад
Director, Regulatory Data Office Leader (Regulatory Data Governance)
150 000 - 258 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Regulatory Data Office Leader (Regulatory Data Governance): Leading global regulatory data governance, stewardship, and the Regulatory Data Hub to enable trusted data for analytics, decision-making, and regulatory transformation with an accent on data quality, standards, and compliance. Focus on governing end-to-end Regulatory Information Management, supporting AI-enabled submission tools, and aligning global teams across R&D, IT, Data Science, and Artificial Intelligence.
Location: Hybrid role based in Horsham, Pennsylvania; Raritan, New Jersey; or Titusville, New Jersey, United States. The role may also be posted for the United Kingdom, Belgium, the Netherlands, or Switzerland under separate requisitions.
Salary: $150,000–$258,750 base pay annually
Company
Johnson & Johnson develops healthcare, Innovative Medicine, and MedTech solutions focused on preventing, treating, and curing complex diseases.
What you will do
- Lead the Regulatory Data Office, global data stewards, and regulatory data governance capabilities.
- Own the Regulatory Data Hub and establish policies, standards, definitions, business rules, and data quality metrics.
- Chair the cross-functional Regulatory Data Council and align central, regional, and local regulatory data needs.
- Support end-to-end Regulatory Information Management transformation through the Unified Regulatory Platform.
- Partner with R&D, IT, Data Science and Artificial Intelligence, and enterprise stakeholders on eLabeling, master data management, submission excellence, automation, and AI-enabled tooling.
- Connect data governance with process design and decision enablement across the Regulatory Knowledge and Process Excellence organization.
Requirements
- Bachelor’s degree in Science, Business, Computer Science or Technology, Regulatory Affairs, or an equivalent field.
- At least 10 years of experience in a pharmaceutical, MedTech, or related healthcare environment.
- Regulatory Affairs knowledge and at least 2 years of people management experience.
- Experience owning data standards, quality, metadata, stewardship, governance, and issue resolution in a regulated environment.
- Strong data analysis, governance, quality management, compliance, project leadership, communication, negotiation, and conflict-resolution skills.
- Ability to influence without authority and build trust across a global, matrixed organization.
Nice to have
- Experience with Veeva Vault RIM, IDMP, SPOR, xEVMPD, and structured content.
- Experience leading data stewards or data governance in a regulated environment.
- Understanding of regulatory connections with R&D, clinical, safety, and supply chain processes.
- Experience with digital transformation, agile value realization, and AI-enabled tooling.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo and equal-opportunity principles.
- Retirement pension and 401(k) savings plans.
- Long-term incentive program eligibility.
- Vacation, sick time, holidays, parental, caregiver, bereavement, volunteer, and military spouse leave.
- Accommodation support is available during the interview process for applicants with disabilities.
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