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    Director -Regulatory Operations Vendor Oversight

    Organon
    8+ years
    Not Disclosed
    Belgrade Mumbai
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: MBA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Director, Vendor Oversight & Partnership Excellence

    Organization: Organon Research & Development
    Division: Global Regulatory Affairs Operations and Partnership Excellence
    Department: RA Portfolio Optimization and HUB Operations
    Location: Remote Work Available
    Travel: 10%

    Position Overview

    The Director of Vendor Oversight & Partnership Excellence is responsible for overseeing vendor relationships and regulatory activities, managing external partnerships, and driving the delivery of high-quality regulatory submissions. The role encompasses strategic assessment of insourcing versus outsourcing strategies and directing activities across multiple parallel workstreams. The incumbent ensures alignment with Regulatory Affairs (RA) strategies and collaborates closely with Procurement and other internal teams.

    Key Responsibilities

    1. Governance and Oversight:

      • Establish and manage governance standards and oversight processes for external vendors, ensuring alignment with Organon policies and quality standards.
      • Monitor vendor performance, escalate issues, and manage risks effectively.

    2. Vendor Relationship Management:

      • Develop and maintain strong partnerships with external vendors to ensure regulatory deliverables meet timelines and quality standards.
      • Communicate performance updates and due diligence outcomes internally and externally.

    3. Operational Management:

      • Oversee sourced submission deliverables, ensuring compliance with global regulatory requirements.
      • Collaborate with stakeholders to optimize regulatory operations and improve submission processes.

    4. Quality and Compliance:

      • Ensure adherence to quality standards by conducting audits, tracking KPIs, and collaborating with compliance teams.
      • Support audit activities and maintain compliance documentation.

    5. Process Improvement and Innovation:

      • Drive continuous improvement initiatives by assessing vendor capabilities and introducing new tools, technologies, and processes.
      • Support sourcing strategy updates in line with organizational priorities.

    6. Cross-functional Collaboration:

      • Engage with internal teams and external vendors to ensure smooth project execution.
      • Lead quarterly reviews with oversight leads to discuss resource allocation, performance, and improvement opportunities.

    7. Budget Management:

      • Monitor vendor-related expenses and escalate unexpected trends to ensure proper budget utilization.

    8. Regulatory Strategy Alignment:

      • Assess insourcing versus outsourcing needs and provide input on vendor selection and resource allocation.

    Required Education, Experience, and Skills

    Education:

    • Required: Bachelor’s degree in Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry, or related fields.
    • Preferred: Advanced degree or MBA.

    Experience:

    • Minimum of 8 years in the healthcare, consumer care, regulatory affairs, or pharmacovigilance sector, including vendor management.
    • Minimum of 6 years in project management or oversight roles.

    Technical and Professional Skills:

    • Solid understanding of regulatory submission, publishing, and planning processes.
    • Strong knowledge of global safety processes and compliance requirements.
    • Experience with governance frameworks, KPIs, and root cause analysis.
    • Proficiency in Microsoft Office, SharePoint, and project management tools.

    Competencies and Leadership Qualities

    • Strong interpersonal, communication, and organizational skills.
    • Proven ability to work in matrix environments and foster cross-functional collaborations.
    • Flexibility and adaptability to changing priorities and environments.
    • Cultural sensitivity and experience in multi-geographical and multicultural contexts.
    • Critical thinking, problem-solving, and strategic decision-making skills.
    • Demonstrated capability to drive change, innovation, and continuous improvement.

    About Organon

    Organon is a global healthcare company committed to delivering health solutions focused on women's health, biosimilars, and other innovative products. Our vision is to make a better and healthier day for every woman, while fostering a diverse and inclusive workplace.

    Employment Details

    • Status: Regular
    • Relocation Assistance: Not available
    • Visa Sponsorship: Not available
    • Flexible Work Arrangements: Remote work options available

    Organon values diversity and inclusion, encouraging applicants from varied backgrounds to apply.

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