Associate Director, Global Patient Safety Standards & Training

We need to output HTML fragment with sections: headings using

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. Also remove "When & Where Work Location: Sleepy Hollow, NY, Warren, NJ or Cambridge, MA4 days per week on site25% Travel may be required" maybe that is location and schedule info; schedule maybe? It includes location and on-site days and travel. That could be considered Schedule? Actually schedule: "4 days per week on site" and "25% Travel may be required". That's schedule info. Also location maybe not needed but could be part of About the role? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have sections: About the role (summary), Responsibilities (list), Requirements (maybe education/experience), Qualifications (maybe similar), Skills (maybe specific skills), Benefits (if described), Pay (salary range), Schedule (location, on-site days, travel). Must not create sections with filler like "commensurate with experience". We have specific content for many. We need to extract substantive info: - About the role: first paragraph: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Global Patient Safety Standards & Training team. Reporting to the Head of Global Patient Safety (GPS) Standards & Training, this position is responsible for establishing and maintaining procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards. A key part of the role is close collaboration with the Process and Procedures (P&P) team and support of the Process Owner Network (PONs). The responsibilities of this job are foundational in the creation and maintenance of the Pharmacovigilance (PV) System that is essential in enabling the department, and therefore the company, to comply with regulatory PV requirements in all relevant territories worldwide, and to operate efficiently and effectively in alignment with established industry practices. The role supports GPS activities and ensures procedures remain compliant with applicable global regulations as they evolve. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide." That's about the role. - Responsibilities: bullet list after "Discover Your Role". Many bullet-like sentences each starting with a verb. We need to capture each as

. Let's list them: 1. Ensure that PV Intelligence updates are systematically assessed and reflected in GPS procedures, so that documented processes remain aligned with current regulatory expectations and the procedural framework is maintained in a state of audit and inspection readiness at all times. 2. Act as a key liaison to Process & Procedures (P&P) and the Learning Centre of Excellence (LCoE) for procedural updates, so that procedural changes are accurately captured, appropriately sequenced, and correctly reflected in the associated training curriculum. 3. As an SME, partner with the Head of GPS Safety Operations to validate that procedures are fit for purpose against safety practices, closing gaps between documented process and operational execution, including the mapping of procedural documents to regulations and to the training curriculum. 4. Apply deep PV process design expertise to develop, implement, and maintain GPS procedures in alignment with regulations, Regeneron Standards, and industry best practices — in partnership with Process & Procedures (P&P), Process Owners, and SMEs — and lead the assessment of evolving global PV regulations. 5. As a primary liaison to P&P, partner to set risk-based prioritization and sequencing in managing procedural updates across the GPS framework, in partnership with PONs and GPS Functional Leads. 6. Assist in ensuring the correct procedural documents are assigned to the relevant training curriculum. 7. Maintain oversight of and support for GPS Planned Process Deviations (PPDs), including guiding SMEs on meeting Global Development Quality (GDQ) approval criteria. 8. Coordinate with P&P to align PPD expiration dates with queued procedure projects, adjusting prioritization as needed. 9. Serve as GPS's escalation point for internal process and quality-event alignment challenges related to procedural updates, working in alignment with senior management and key stakeholders to investigate and resolve non-compliance. 10. Manage, alongside the Process Owners, the content of procedures for GPS, escalating material gaps to senior management, including the maintenance and accuracy of PSMF Annex E in relation to GPS procedures. 11. Maintain an overview of CAPAs associated with procedures, including those arising from both audits and inspections, and work closely with SMEs, PONs and the P&P team to ensure timely CAPA closure, including allowing appropriate time for associated training. 12. Provide regular metrics on CAPAs, process deviations, and training compliance to GPS department leadership. 13. Lead initiatives to enhance GPS process effectiveness and efficiency, including the analytical framework for performance metrics, and present findings and recommendations to leadership. 14. Liaise regularly with other functional teams e.g. Corporate and Clinical QA on potential impacts to GPS Processes or GXP-related activities. 15. Represent Standards & Training in audits and inspections. 16. Serve as the back-up GPS Standards & Training liaison to LCoE. That's responsibilities. - Requirements: The section "This Role Requires Minimum Bachelor's degree is required. Education in the life sciences is a strong plus.7+ years' experience of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry.Thorough understanding of Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.Extensive experience managing procedural updates.Experience in PV process design and optimization.Track record of successful project management relevant to document management.Strong organizational skills.Ability to write procedural documents to accepted standards of quality.Experience presenting in audits and inspections.Ability to work collaboratively across functions with SMEs, process owners and cross-functional partners.Experience with Data Privacy is a plus" We can split into Requirements (education + years experience) and Qualifications maybe? But we can combine into Requirements and Qualifications sections. The instruction says we can have sections like Requirements, Qualifications, Skills. We need to decide what goes where. We have education, years experience, understanding of regulations, experience managing procedural updates, experience in PV process design and optimization, track record of project management, strong organizational skills, ability to write procedural documents, experience presenting in audits/inspections, ability to work collaboratively, experience with Data Privacy (plus). Those could be qualifications/skills. Maybe Requirements: Minimum Bachelor's degree required; Education in life sciences a plus; 7+ years' experience in PV/Drug Safety, Regulatory Affairs or QA in pharma/biotech. Qualifications: Thorough understanding of PV/Drug Safety regulations and PV QMS; Extensive experience managing procedural updates; Experience in PV process design and optimization; Track record of successful project management relevant to document management; Strong organizational skills; Ability to write procedural documents to accepted standards of quality; Experience presenting in audits and inspections; Ability to work collaboratively across functions with SMEs, process owners and cross-functional partners; Experience with Data Privacy is a plus. Skills: maybe overlapping but we could treat some as skills: Strong organizational skills, Ability to write procedural documents, Experience presenting, Ability to work collaboratively, Experience with Data Privacy. But we need to avoid duplication. Perhaps better: Requirements (education + years experience). Qualifications (understanding regulations, experience managing procedural updates, PV process design, project management). Skills (organizational, writing docs, presenting, collaboration, data privacy). However the instruction says prefer a few substantive sections over many thin ones. Could combine Qualifications and Skills into one section called Qualifications & Skills. But they gave examples separate. We'll decide to have Requirements, Qualifications, Skills. Now Benefits: The posting mentions: "Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits." Also link for US benefits. That's substantive. So Benefits section. Pay: Salary range: "$157,200.00 - $256,600.00" (annually) for jobs in Canada? Actually says "For jobs in Canada: this posting is for an existing position. Salary Range (annually) $157,200.00 - $256,600.00". So we have pay info. Include Pay section. Schedule: Location and on-site expectations: "When & Where Work Location: Sleepy Hollow, NY, Warren, NJ or Cambridge, MA 4 days per week on site 25% Travel may be required". Also mention "Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location." That's schedule info. So Schedule section: location options, 4 days per week on-site, 25% travel may be required. We must not include boilerplate like EEO, accommodation, background checks, etc. Remove those. Now produce HTML fragment with

headings and

• for lists,

  for prose. We need to ensure we don't repeat job title as heading. Not include any markdown. Let's craft:

  About the role

  ... (the paragraph)

  Responsibilities

  • ... each

  Requirements

  • Minimum Bachelor's degree required.
  • Education in the life sciences is a strong plus.
  • 7+ years' experience of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry.

  Qualifications

  • Thorough understanding of Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
  • Extensive experience managing procedural updates.
  • Experience in PV process design and optimization.
  • Track record of successful project management relevant to document management.

  Skills

  • Strong organizational skills.
  • Ability to write procedural documents to accepted standards of quality.
  • Experience presenting in audits and inspections.
  • Ability to work collaboratively across functions with SMEs, process owners and cross‑functional partners.
  • Experience with Data Privacy is a plus.

  Benefits

  • Annual bonuses or other incentive plans.
  • Equity awards.
  • Pension or retirement benefits.
  • 401(k) company match.
  • Health and wellness programs.
  • Fitness centers.
  • Insurance benefits (medical, dental, vision, life and disability).
  • Paid time off.
  • Family support benefits.

  Pay

  Salary range (annually): $157,200.00 – $256,600.00

  Schedule

  Work locations: Sleepy Hollow, NY; Warren, NJ; or Cambridge, MA. Expected schedule: 4 days per week on‑site, with up to 25% travel required.

  Check for any duplicated content: Ensure we didn't miss any responsibilities