Associate Director, Global PV Product Complaint Management & Oversight

We need to output HTML fragment with sections: About the role? Actually we need to use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We need to parse the job posting. It includes: - Who We Are (company description) – could be "About the role"? Actually "Who We Are" is company overview. Could be placed under "About the role"? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can map content accordingly. We need to preserve all substantive information, remove boilerplate (cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions). Also remove "California, US residents click here." That's likely a navigation link; remove. We need to keep the job details: Who We Are description, Who You Are (role description), responsibilities (the long list), Minimum Requirements, Preferred Qualifications, Job Location (Durham, NC hybrid schedule), Benefits mention (eligible employees may participate in comprehensive benefits suite...), also mention "At United Therapeutics, our mission..." maybe part of About the role? Could be included. We must not repeat the job title as a heading. The job title is "Associate Director, Global PV Product Complaint Management & Oversight". Not to be used as heading. We must not put Job ID/requisition numbers as headings – none present. We need to decide sections: - About the role: could contain "Who We Are" and maybe mission statement. - Responsibilities: the bullet list of duties (the long paragraph after "Who You Are"). - Requirements: Minimum Requirements. - Qualifications: Preferred Qualifications. - Skills: maybe we could extract skills from requirements? But we have separate sections; we could put skills under Requirements or Qualifications. But we need to follow instruction: use sections only when posting has real specific content. The posting includes Minimum Requirements and Preferred Qualifications; we can map those to Requirements and Qualifications sections. Skills could be derived but not explicitly separate; maybe we can omit Skills section if not explicitly stated. However the posting includes many skill-like items within requirements (e.g., Strong written and verbal communication skills, Project management skills, etc.). Could create a Skills section but we must not invent or summarize away detail; we could extract those skill statements and put them under Skills. But the instruction says preserve ALL substantive information; we can keep them in Requirements or Qualifications. It's okay to have them there. - Benefits: posting mentions "Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more." Also link. So we can create Benefits section. - Pay: not mentioned; omit. - Schedule: mentions hybrid schedule: 3 days in office, option to work 2 days each week from home. Also "In office requirements could change based on business needs." So we can create Schedule section. We also have Job Location: Durham, NC office. Could be part of Schedule or separate? Not a defined heading; we could include location within Schedule or maybe under About the role? Probably include location in Schedule section (or maybe a separate "Location" but not in allowed headings). Since only allowed headings are those listed, we can put location inside Schedule or Benefits? Better to put location inside Schedule as it's about work arrangement. Or we could add a brief paragraph under Schedule: "Located at Durham, NC office with hybrid schedule..." We must not include boilerplate like EEO statement, etc. Remove "United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities." Also remove the link to benefits maybe keep description but not the URL? The instruction: preserve ALL substantive information; the URL is substantive? It's a link for additional info; could be considered boilerplate? It's not navigation/legal/EEO; it's a link to benefits. Might keep but it's a URL; we can keep as plain text. We must output only HTML fragment, no /, no markdown fences. We'll structure:

About the role

Who We Are paragraph(s) plus mission statement maybe.

Responsibilities

• ... each duty as list items.

We need to break the long responsibilities into list items. The responsibilities are a long paragraph with many sentences separated by semicolons. We can split into logical items. Let's extract responsibilities from the text after "Who You Are" up to before "Minimum Requirements". The "Who You Are" paragraph includes role description and then a long list of duties. We need to separate the role description (maybe first sentences) from duties. But we can include role description as part of responsibilities or as part of About the role? The "Who You Are" includes: "We are looking for an Associate Director, Global PV Product Complaint Management & Oversight to lead and elevate global Product Complaint Safety governance structure across devices, drugs, combination products, and biologics at a local US and global level at all product life cycles. This position provides direction to the team and vendors with respect to PC Handling/business practices for efficiency, quality, and compliance impacts. The ideal candidate is a confident, collaborative PV and product complaint leader who can turn complex requirements into practical solutions that protect patients and strengthen compliance." That's more of a role summary; could be placed under About the role or Responsibilities. Since we have About the role for company overview, we could put this role summary under About the role as well. But we need to avoid duplication. Let's put company overview under About the role, and the role summary maybe also under About the role? Or we could put it under Responsibilities as an overview. I'd put role summary under About the role as it describes the role. Then the bullet list of duties starts after "This role ensures that operational aspects..." Actually after the ideal candidate sentence, there is "This role ensures that operational aspects of the safety data collected and processed and assessed as product complaints are managed with rigorous global standards..." That starts the duty list. Thus we can treat everything after "This role ensures..." as responsibilities. We'll split by semicolons and maybe by "and". We'll create list items for each distinct duty. Let's extract duties sentences: 1. This role ensures that operational aspects of the safety data collected and processed and assessed as product complaints are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products in accordance with EU MDR requirements, combination reporting requirements (21 CFR 820 and 211), IMDRF requirements, ISO 13485 (quality management systems), ISO 14971 (risk management), IEC 62304 (medical device software), and ISO 10993 (biological evaluation). 2. Functions as horizontal enterprise leader who optimizes and oversees the product complaint governance, inspection readiness, and regulatory compliance across the Product Complaint Safety lifecycle by influencing and implementing strategic initiatives address internal and external business and regulatory issues; 3. Anticipate potential internal and/or external business challenges or regulatory nuances and recommend solutions 4. Design, develop and implement globally harmonized procedures, training materials, and process requirements necessary to support PC handling activities; make operational decisions and provide recommendations related to safety practices/requirements, policies, programs, and compliance activities 5. Evaluate and implement business process changes in response to regulatory updates to ensure the effectiveness PC handling process for drugs, combination products, and/or biologics at a local and global level 6. Initiate, plan, coordinate updates current process, to ensure coverage with new products and compliance with GVP, IMDRF and other regulatory requirements to ensure compliance 7. Responsible for establishing, maintaining and compliance the global product complaint process framework, including policies, standards, procedures, process maps, escalation pathways, and role clarity (i.e. RACI) 8. Oversee day-to-day procedural quality and compliance of end-to-end PC handling activities, including entry within GSD, initiation within QMS, RGA processes, and related activities; Maintain PC operating procedures, including date entry guideline, coding conventions and monitor systems to ensure PCs, MDRs, malfunction reports, FARs, and BPDRs are processed and submitted per SOPs. 9. Review and approve SOPs related to PC handling activities to support the global safety surveillance program/proper management of benefit/risk of UTC products; Establish and maintain risk-based oversight models to ensure PC compliance with global pharmacovigilance regulations, contractual obligations, and company standards 10. Ensure all product complaints are managed in accordance with applicable global regulations, company quality standards, and internal procedures (e.g., 21 CFR 211.198, EU GMP Chapter 8, ICH Q10, 21 CFR 820.198, 803 (MDR), IMDRF guidelines, and EU MDR/IVDR vigilance requirements). 11. Maintain current knowledge of regulations, guidelines, and industry best practices related to PC handling, investigations, and MDR reporting; Evaluate emerging regulatory, operational, and business risks associated with PC handling and reporting activities and develop mitigation plans; Assess the impact of regulatory changes and implement necessary process, system, and governance updates; Monitor Key Process Indicators (KPIs) and compliance metrics to ensure adherence to global reporting timelines (e.g., FDA, EMA, and ISO standards) 12. Serve as the primary escalation point for PC handling, combination reporting, MDR reporting, compliance, governance, quality, and safety-related operational issues; Recommend improvements to PC oversight programs, governance processes, quality systems, and operational processes. 13. Lead process reviews and governance forums to assess process effectiveness, compliance, resource, and opportunities for continuous improvement 14. Develop and deliver training and training materials for PC handling in accordance with SOPs, global regulations, guidelines, and industry standards; Provide training and education in conjunction with the Brand Safety Lead (BSL) and the product FMEAs regarding potential product complaints and user issues 15. Lead cross functional initiatives to strengthen inspection readiness, compliance, and operational effectiveness; Act as the point of contact for inspections and audits related to Global Product Safety (GPS) product complaint handling activities; Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPAs are implemented; Review and approve deviations and CAPAs for any related activity as needed 16. Develop, implement, and maintain new or revised SOPs; Update and maintain procedural documents related to GPS PC Operations, workflows, and PVAs; Lead strategic improvement initiatives to strengthen the effectiveness, efficiency, and control of the product complaint process/lifecycle; Partner with Quality Systems and/or IT/GPS Systems and Analytics team to define business requirements and optimize digital tools/workflows supporting complaint management 17. Direct and manage direct reports to include training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process, as needed 18. Exercise independent judgement when evaluating complex compliance issues, safety reporting challenges, inspection observations, and regulatory risks; Balance patient safety, regulatory obligations, business objectives, operational feasibility, and organizational risk 19. Perform other duties as assigned Now Minimum Requirements: list of bullet-like sentences separated by commas or line breaks. We'll extract each requirement as list item. Minimum Requirements text: "Bachelor’s degree in a related field or BSN 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs or product complaint handling with a bachelor's degree, or 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs and/or PC handling with a master's degree, or 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs and/or PC handling with a PharmD or international equivalent 4+ years of experience supporting devices,