Job Description
Strategic Leadership & Operational Excellence
- Lead global Safety Data Management processes, governance, and documentation to ensure compliance, quality, and inspection readiness.
- Drive continuous improvement, simplification, and automation of SDM processes and technologies.
- Provide strategic direction for safety case management, medical coding, and operational performance across geographies.
- Monitor industry, regulatory, and technology developments and translate them into business improvements.
Quality, Compliance & Inspection Readiness
- Ensure adherence to SOPs, GxP, ICH-GCP, pharmacovigilance regulations, and enterprise standards.
- Oversee quality management activities, governance frameworks, training strategies, and process controls.
- Support regulatory inspections, audits, CAPA management, and resolution of compliance findings.
- Maintain global consistency across documentation, training, and operational practices.
Technology & Cross-Functional Leadership
- Partner with Global Clinical Safety & Pharmacovigilance, GDIA, IT, and vendors to optimize systems, workflows, automation, and data integration.
- Influence technology roadmaps, system enhancements, and digital capabilities that improve efficiency and compliance.
- Lead implementation of system releases and process changes to ensure business continuity and operational readiness.
- Develop business cases and recommendations to support investment and prioritization decisions.
People Leadership
- Lead and develop a high-performing global organization through coaching, succession planning, talent development, and performance management.
- Establish clear goals, priorities, and accountability aligned with organizational strategy.
- Partner with HR on recruitment, workforce planning, employee relations, and organizational capability building.
- Manage resources and budgets to ensure effective delivery against business priorities.
Required
- Bachelor's degree with 10+ years, or Advanced degree with 8+ years of relevant experience, including significant biopharmaceutical industry experience and 3+ years of people leadership experience.
- Deep expertise in ICSR management, medical coding, pharmacovigilance regulations, and Safety Data Management.
- Strong understanding of safety systems, coding platforms, reporting tools, automation, and system validation.
- Experience leading regulatory inspections, audits, quality oversight, and operational performance management.
- Knowledge of resource planning, capacity management, and process optimization.
- Exceptional communication and stakeholder management skills.
- Proven ability to lead through influence in complex global environments.
- Strong strategic thinking, problem-solving, and change management capabilities.
- Demonstrated success building collaborative, inclusive, and high-performing teams.
- Ability to translate complex scientific, medical, and regulatory information into business decisions.
Required Skills:
Adaptability, Adaptability, Case Management, Clinical Data Management, Data Validation, Decision Making, eCRF, Ethical Standards, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Medical Insurance Coding, Mentoring Staff, Metadata Management, Mitigated Risks, Organizational Performance Management, People Leadership, Pharmacovigilance, Process Standardization, Psychological Safety, Risk Mitigation Strategies, Standard Operating Procedure (SOP), Strategic Leadership, Strategic Thinking, Study Data Tabulation Model (SDTM), System Validation {+ 1 more}Preferred Skills:
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Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/13/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Skills Required
- Bachelor's degree with 10+ years relevant experience or advanced degree with 8+ years
- 3+ years people leadership experience
- Deep expertise in ICSR management
- Experience with medical coding and coding platforms
- Strong knowledge of pharmacovigilance regulations and GxP/ICH-GCP
- Experience with safety systems, reporting tools, and system validation
- Experience leading regulatory inspections, audits, CAPA management
- Experience in process optimization, resource planning, and capacity management
- Ability to develop business cases and influence technology roadmaps
- Exceptional communication and stakeholder management skills
- Proven ability to lead through influence in global environments
- Strategic thinking, problem-solving, and change management capabilities
- Experience building collaborative, inclusive, high-performing teams
- Ability to translate complex scientific, medical, and regulatory information into business decisions
What We Do
MSD Animal Health Technology Labs specializes in the development of animal health management solutions. We are a multidisciplinary product company, a diverse team of ~450 closely collaborating scientists, AI experts, software, hardware, and mechanical engineers… working alongside veterinarians and other animal experts. Our passion? Shaping the future of animal health and well-being (for much better!). Our products and platforms identify trends and predict the likelihood of health outcomes for HUNDREDS of MILLIONS of animals each year, from pets, to poultry, farm animals, and even fish. We provide actionable insights for veterinarians, farmers, and producers, changing the way people care for animals in 150 markets. So, if you’re looking to work in a company that combines pioneering science and technology, dedicated colleagues, and animals, you’ll find it all here – come join us! Visit our website: https://www.msd-animal-health.com/animal-health-intelligence/technology-labs/
