Manager, Business Practice Officer
PharmaBiotechMedTechPharmacovigilanceRegulatory AffairsQuality Assuranceheorveevapharmacovigilanceemacroraveaws
Job description
Job Description Manager, Business Practice Officer Provides operational support In collaboration with the Business Practices Compliance officer in Country Compliance Committee and to Country Leadership Team, supporting all compliance programs. The Business Practices Officer plays a pivotal role in embedding ethical business practices and a culture of integrity across the organisation. This role ensures compliance with global and local regulations, supports risk mitigation efforts, and drives continuous improvement through audits, training, and policy alignment. The BPO acts as a strategic advisor to business units, enabling compliant business performance while fostering a proactive compliance culture. Main responsibilities include but are not limited to: Key Responsibilities: Business Practice Governance Lead implementation of business practice frameworks in collaboration with BPM. • Conduct regular monitoring (e.g., EmpowerBI), self-audit checks on Veeva events, and risk mitigation actions. • Support Enterprise Risk Assessments and compliance sub-certifications. • Act as primary liaison for business units (e.g., Oncology, Vaccines, Pharma) other functions as applicable on policy guidance and HCP/HCO engagement reviews. Oversight and Coordination with Regulatory function, Pharmacovigilance, Promotional material development process adherence, contracting compliance along with (Commercial Operations guidance) of OPPI and other relevant and changing local pharma promotional codes such as UCPMP code. Proper reflection in internal SOP. Policy & SOP Management • Align assigned global standards with local guidance documents and support their development, review & communication. • Maintain business practice documentation and relevant repositories (e.g., SharePoint). • Provide interpretative guidance and support simplification initiatives (e.g., Veeva system updates). Prepare business risk dashboards and reports for Country Compliance Committee,Due Diligence Oversight. • Advise on due diligence and compliance risk assessments for vendors and distributors. • Monitor and support Business in Restricted Party Sanction Screening (RPSS) reports. • Train key stakeholders on due diligence processes and systems for vendors and individuals. • May serve as Country system administrator Privacy • Act as Privacy Steward and Data Privacy Officer implementing privacy programs. Making sure that all trainings are conducted and tracked for assigned policy areas and market has proper controls which can be demonstrated in Internal and external audits Qualifications: · Good understanding of pharmaceutical companies’ infrastructure and processes, policies · Experience in Internal audit or compliance work in Pharma or Medical devices sector · Familiarity with compliance guidelines and data protection legislation · Proven ability to develop cooperative professional relationships within the organization · Strong communication, interpersonal, and organizational skills Expertise in all compliance related aspects, including laws, regulations, procedures, policies and SOPs; awareness of international guidelines and rules · Pronounced diplomacy with strong negotiation skills; demonstrated ability to influence business management; strong cultural awareness · High ethical standards, being a role model of business compliance and integrity Key Working Relationships • Internal: Business Unit Directors, IL&C, Medical, Regulatory, Market Access, HR, IT, Finance, Communications, PSRs, Product Managers, Sale & Marketing Managers. • External: Industry associations (e.g., KRPIA), co-promotion partners, vendors, government agencies. Education & Experience Chartered Accountant or Lawyer LLB or Bachelor Pharmacist with audit & compliance experience or with relevant work experience. 6 - 8 years of Big4 Audit (preferred), Internal Audit, compliance experience in Healthcare, including privacy, or comparable experience in healthcare industry. Required Skills: Adaptability, Adaptability, Business Management, Compliance Activities, Compliance Monitoring, Compliance Remediation, Compliance Reporting, Compliance Support, Customer Risk, Data Privacy, Data Privacy Law, Data Protection Laws, Detail-Oriented, Diplomacy, Financial Compliance, Government Regulation, Legal Compliance, Policy Governance, Policy Implementation, Privacy Laws, Privacy Regulations, Problem Solving, Process Simplification, Project Risk Assessments, Regulatory Affairs Management {+ 7 more} Preferred Skills: Current Employees apply HERE 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/17/2026 *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.
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