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    Senior Specialist Regulatory Project Management Office

    Merck Kgaa
    8-14 years
    Not Disclosed
    Bangalore
    10 Dec. 31, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Work Your Magic with Us!

    Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our diverse mix of people, customers, patients, and the planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

    Your Role:

    The Regulatory Project Manager Officer will be a key member of the GRA Portfolio Management Team, contributing to defining the annual strategic direction to evolve the impact of the function for the GRSTs / IRSTs and GRA functions. This includes managing timelines, risks, priorities, direct costs, and FTE demand.

    In this matrix organization role, you will communicate and collaborate extensively with stakeholders from various functions within or outside Global Regulatory Affairs. The position ensures that employees are prepared to work on different projects and roles, facilitates communication within the matrix organization, and ensures efficient and scalable resourcing aligned with business priorities.

    Who You Are:

    Experience:

    • 8–14 years of work experience in a pharmaceutical environment, competent authority, or academia/R&D related to the role.
    • Minimum 6-8 years in regulatory affairs or regulatory project management office experience.

    Education:

    • Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent). A higher degree (e.g., PhD) is preferable.
    • Advanced training in portfolio & project management-related disciplines will be a strong advantage.

    Job Specific Competencies & Skills:

    Key Accountabilities:

    • Act as PMO for GRSTs, creating, maintaining, and evolving templates and tools used within the GRSTs.
    • Collaborate closely with RPMs and GRLs to ensure templates and tools are appreciated across the asset lifecycle, allowing quick access to relevant information in a harmonized fashion.
    • Consolidate GRST relevant information at the portfolio level on a quarterly basis (GRA Healthcheck).
    • Collaborate with leaders in TA Onc and TA Finer to steer, review, and evolve metrics and KPIs measured in the GRA Healthcheck to provide a transparent overview.
    • Generate insights from data and reports to provide recommendations for improvements, enabling a learning organization.
    • Perform the annual GRST survey to gain insights on the perception of Global Regulatory Strategy Team members, providing feedback to GRSTs and leaders across the TAs, functions, and regions.
    • Collaborate with SPH and RQS Operations to define business questions and requirements for reports and analyses, enabling the generation of GRA insights.
    • Serve as the iMAP steward for the GRA functions.
    • Be a member of the RQS SME group for FTE demand forecasting.
    • Collaborate closely with the Strategic Sourcing and Planning team within RQS Operations.
    • Coordinate the FTE demand planning SME group for GRA functions (TA Onc, TA Finer, REG CMC, REG Intl., Labeling, and GRASP).
    • Orchestrate the monthly update of skill assignments in the HR system for GRA functions and perform necessary updates for TA FINER and TA Onc.
    • Work with GRA functions to generate insights on scenarios having resource implications for the functions and skills.

    Skills:

    • In-depth knowledge and experience in regulatory affairs, R&D, process, and technology solutions.
    • Knowledge in business administration is a plus.
    • Portfolio & project management experience is essential.

    Financial Dimension:

    • Support RPMs in updating the iMAP system for quarterly direct cost planning, enabling the consolidation of direct cost demand and comparing with actual spending assigned to the GRA part of the PST budget.

    Job Location:
    Electronic City Phase 1, Bangalore

    What We Offer:

    We value diverse perspectives and life experiences, believing they drive excellence and innovation. We are committed to creating opportunities for growth, enabling you to develop at your own pace. Join us in building a culture of inclusion and belonging that impacts millions, empowering everyone to work their magic and champion human progress!

    Apply now and become a part of our diverse team!

    US Equal Employment Opportunities:
    The Company is an Equal Employment Opportunity employer. No employee or applicant will be discriminated against on any basis, including race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy applies to all employment-related decisions.

    North America Disclosure:
    If you are a resident of California, Colorado, Hawaii, Maryland, New York, Washington, or Washington, DC, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. Please contact 855-444-5678 from 8:00am to 5:30pm ET Monday through Friday.

    Notice on Fraudulent Job Offers:
    Be aware of third parties pretending to represent our company offering unauthorized employment opportunities. For more details, please refer to our official company page.

    What We Offer:
    Beyond financial rewards, we provide a range of attractive benefits to support your personal and professional growth:

    • Saving & Financial: Our 401(k) Plan includes a generous company-matching contribution and discretionary yearly contributions, tax-advantaged accounts, and life insurance.
    • Health & Wellness: Comprehensive medical, dental, and vision coverage, including virtual care through Telehealth and free behavioral health counseling.
    • Voluntary Benefits: Protection from high healthcare costs, discounts on auto, home, and pet insurance, and low-interest personal loans.
    • Work/Life Support: Generous paid time off, back-up daycare services, education assistance, and more.

    Our Recruiting Process:

    1. You Apply: Complete your online application for the role that aligns with your qualifications and interests.
    2. We Screen: We review your application to determine if you're a good fit.
    3. We Assess: We invite you for interviews by phone, video, or in person.
    4. Mutual Agreement: If we’re the right match, we hope you’ll join us!
    5. Work Your Magic: We ensure a smooth onboarding process to help you succeed from day one.

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