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Senior Specialist - Country Liaison, Operational Excellence

6+ years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Full Time Education: olid understanding of regulatory processes, compliance, and documentation 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 Title:

Senior Specialist – Country Liaison, Operational Excellence

πŸ†” Job ID:

288967

πŸ“ Location:

Bangalore, Karnataka, India

πŸ•’ Job Type:

Full-time


🌍 About Merck:

At Merck, we are united by curiosity and a shared goal to enrich lives through science and technology in Healthcare, Life Science, and Electronics. We dream big and care deeply about our people, patients, and planet. Our inclusive and diverse global teams push boundaries to reimagine the unimaginable.


🎯 Your Role – Key Responsibilities:

As a Senior Specialist – Country Liaison in Operational Excellence, your responsibilities will include:

πŸ”§ Regulatory Affairs Coordination & Support:

  • Support and coordinate Regulatory Affairs (RA) projects and Regulatory IT systems globally.

  • Define or confirm regional regulatory approaches for upcoming local product changes.

  • Serve as internal International Regulatory Affairs point of contact for Therapeutic Area (TA) and RQS operations.

  • Collaborate cross-functionally to align regulatory strategies at a regional level.

🧠 Subject Matter Expertise & Training:

  • Act as SME/Champion for new regulatory systems and processes.

  • Contribute to and create training documentation for onboarding and system rollouts.

πŸ“‹ Compliance & Inspection Readiness:

  • Coordinate and support Country Audit & Inspection readiness efforts.

  • Lead compliance and data governance initiatives (data cleansing, monitoring, AI support).

  • Oversee VV processes with a focus on regulatory requirements and standards.

πŸ“Š Process & Data Management:

  • Update management through document localization (RIMS local repository).

  • Monitor and generate compliance reports on data quality standards.

  • Identify duplicated/contradictory processes and propose quality-driven optimizations.


πŸ‘€ Who You Are – Required Qualifications & Skills:

🧬 Experience & Knowledge:

  • 6+ years of experience in Regulatory Affairs.

  • Solid understanding of regulatory processes, compliance, and documentation.

  • Experience in process optimization, audits, and data quality monitoring.

πŸ›  Skills & Competencies:

  • Strong time management, task prioritization, and multi-tasking abilities.

  • Effective communicator with a proactive approach to collaboration and escalation.

  • Ability to work in a fast-paced, matrixed environment.

  • High attention to detail and focus on confidentiality.

  • Experience in process improvement and performance metrics tracking.

  • Strong team learning mindset – capable of mentoring or planning apprenticeships.

🌐 Languages:

  • High proficiency in English (written and spoken).


πŸ’Ό What We Offer:

🎁 Benefits Package Includes:

πŸ’Έ Financial & Protection:

  • Competitive compensation and long-term financial stability.

πŸ₯ Health & Wellbeing:

  • Medical insurance, health check-ups, mental health support.

πŸ‘¨‍πŸ‘©‍πŸ‘§‍πŸ‘¦ Family:

  • Fertility benefits and family support across all life stages.

🌴 Time Away:

  • Paid leave for rest and life events.

🧘 Lifestyle:

  • Flexible working, gym memberships, vehicle benefits, and shopping discounts.


πŸ” Our Recruitment Process:

  1. You Apply – Submit your application online for relevant roles.

  2. We Screen – Applications are reviewed, and shortlisted candidates are invited to the next stage.

  3. We Assess – Interviews (phone, video, or face-to-face).

  4. Mutual Agreement – Offer is made if you're the right fit.

  5. Work Your Magic – Onboarding starts to welcome you to Merck.


⚠️ Fraud Alert:

Be cautious of fake job offers claiming to represent Merck. Verify authenticity through official Merck career portals.


🌈 Diversity & Inclusion Statement:

Merck celebrates diverse backgrounds, perspectives, and experiences. We believe inclusion drives excellence and innovation. Join us in shaping a culture that empowers every individual to work their magic.