Job DescriptionThe
Director, Medical Coding is accountable for the global leadership of
Safety Data Management (SDM), Individual Case Safety Report (ICSR) management, medical coding operations, quality oversight, inspection readiness, system enablement, process optimization, and people leadership.
Key Responsibilities- Provide strategic leadership and oversight of global Safety Data Management (SDM) operations, ensuring compliant, high-quality execution of case processing, medical coding, documentation, and training activities.
- Lead the development, governance, and continuous improvement of SDM processes, capabilities, and operational frameworks to meet evolving business and regulatory requirements.
- Ensure global inspection readiness, regulatory compliance, and adherence to pharmacovigilance, GxP, ICH-GCP, and company quality standards.
- Oversee process standardization, quality management, documentation lifecycle management, training programs, and operational governance across global teams.
- Drive operational excellence through process optimization, risk mitigation, performance monitoring, quality trend analysis, and implementation of corrective and preventive actions (CAPAs).
- Partner with Global Clinical Safety & Pharmacovigilance, IT, Data Integration & Automation, and external vendors to advance system enhancements, automation, and digital transformation initiatives.
- Provide strategic input into technology roadmaps, platform governance, system releases, and business cases that support future-state safety data operations.
- Lead audit and inspection support activities, serving as an escalation point for compliance issues and high-impact regulatory findings.
- Build and maintain strong cross-functional partnerships to ensure alignment, stakeholder engagement, and successful delivery of enterprise priorities.
- Manage and develop high-performing teams through effective goal setting, coaching, performance management, succession planning, talent development, and recruitment.
- Oversee workforce planning, budget management, and optimization of internal, contingent, and offshore resources to support organizational objectives.
- Foster an inclusive, collaborative, and high-performance culture that promotes continuous learning, innovation, accountability, and employee engagement.
Required Education & Experience- Bachelor's degree in Life Sciences or related field with a minimum of 10 years of relevant experience, including 7 years in the biopharmaceutical industry and 3 years of people leadership experience; OR
- Advanced degree (Master's or Doctorate) in Life Sciences or related field with a minimum of 8 years of relevant experience, including 5 years in the biopharmaceutical industry and 3 years of people leadership experience.
Required Skills & Expertise- Deep subject matter expertise in pharmacovigilance, ICSR processes, medical coding, safety data management, and global regulatory requirements.
- Strong understanding of clinical development, global safety operations, compliance frameworks, and inspection readiness.
- Experience leading global, cross-functional teams and driving operational excellence across complex safety data management environments.
- Demonstrated expertise in performance management, resource planning, capacity modeling, process optimization, and data-driven decision-making.
- Knowledge of safety systems, databases, reporting tools, workflow validation, automation, and technology-enabled process improvements.
- Excellent analytical, problem-solving, communication, and stakeholder management skills, including the ability to influence senior leaders and drive alignment across global organizations.
- Proven ability to lead change, manage ambiguity, and foster an inclusive, high-performing team culture.
- Fluent English communication skills, both written and verbal.
Preferred Competencies- Strategic leadership, customer focus, and enterprise mindset.
- Strong partnership-building and networking capabilities across global and cross-functional teams.
- Continuous improvement mindset with demonstrated success driving transformation and innovation.
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: Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:The salary range for this role is
$173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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: Regular
Relocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Hybrid
Shift: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. 
