Job Description

General Purpose/Roles

The Compliance BPO leads the localization, implementation and reporting on country compliance processes.  The position works with the BPO team, legal, regional compliance and local commercial leadership team to develop and execute compliance and risk management programs or action plans, including local implementation of tools/ systems to support controls, training and communication, and monitoring of key risk indicators at the country level to establish or maintain a strong compliance culture and infrastructure.

Reporting Line

The BPO Lead will report into Commercial Operations Director. One BPO specialist is reporting into the BPO Lead.

Specific Roles and Responsibilities

Implementation of Key Processes and Systems 

Lead and coordinate the Country Compliance Committee (CCC) process.Develop & monitor SOPs to align with local regulations & code of conduct. Support implementation for the incorporation of global policies / divisional or regional guidance into local SOPs.Participate in the development, review, revision, communication and distribution of local SOPs (with the appropriate business owner).Provide interpretative guidance.Provide feedback to global and regional teams to ensure well targeted and balanced policy development.Lead the Patient Program Committee process.Lead the Enterprise Risk Management (ERM) process.Key partner in ensuring annual achievement of local management compliance certification.Learning management system follow-up to ensure overall adherence to timelines.Partner with Finance to ensure adherence to financial controls in relation to HCP engagement.Localize and implement global policies and or procedures as they are rolled out - and ensuring alignment with current local compliance processes, includes reporting to the local leadership team on areas of risk.Conduct & Lead the Risk Management reviewReview and continually simplify and streamline policies and procedures, integrating compliance controls into normal business activities and procedures to help achieve continued compliance and adherence to policy.Establish or maintain other compliance processes or systems to ensure tracking and compilation of actions and documentation of other control or risk management requirements related to FCPA and Privacy.As needed, act as market lead for relevant Company or other Audit programs.Support global/regional system implementation as data source liaisonConduct or oversee the Compliance team in their day-to-day management of Compliance Business Support Activities

Tracking & Monitoring

Support Compliance Scorecard achievement through monitoring and follow up of KPIs.Monitor and conduct regular self-audits of systems and processes (e.g. Insight, Empower BI, Veeva, Privacy Inventory, etc.) to identify gaps, and ensure follow up with the business of required actions and documentation.Support audit and Privacy Annual Certification remediation follow-up to ensure audit findings are resolved in a timely way and effective controls established.Periodically provide monitoring / control processes for the following risk areas – review CME activities; financial interactions with HCPs; grants, donations and charitable contributions; internal FCPA/anti-bribery process control with spot checksPeriodically provide data to be reported for local monitoring / control processes for FCPA/anti bribery system implementation, e-event system reporting, sample management report, etc.

Training & Communication

Support and execute effective compliance training and communication programs, including classroom-based train-the-trainer programs (e.g. new hires, new SOP) and other country-specific training requirements (e.g. new systems, audit remediation, refresher training).

Privacy Stewardship

Promotes awareness of the Company’s Privacy Program and requirements across the local organization.First point of contact for employees in the local organization for privacy related matters.Active member of the Company’s Privacy Community and named by the local Country/Function Lead as a member of the Global Privacy Office (GPO) Steward Network.Primary liaison between local organization and GPO and assists with bidirectional communications to support the Company’s Privacy program and objectives.Proactively identifies privacy risks and gaps in the local business/function and partners with GPO on appropriate remediation activities.Actively collaborates with GPO on the development and continuous improvement of the Company’s Privacy Program.

QUALIFICATION & SKILLS

University Degree, Preferably in Law, Business, Biology…etc.,Minimum 5 years experiences in compliance / preferably having audit backgroundSubstantial experience in business or training departments especially in Pharma IndustryGood knowledge of the pharmaceutical industry and health issues and its business code of conductStrong written and verbal communications skills (both in English and Indonesia language)Demonstrates initiative, strategic thinking and creative problem solving in response to the communications challenges and opportunitiesAbility to work effectively under intense stress and pressure especially in a crisis/issueStrong collaboration skills, assertiveness and couragePrior privacy or compliance experience and/or or a strong interest in privacy related matters.Trustworthy, Knowledge of and passion for ethical conduct and compliance

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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:

01/31/2025

*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.

Requisition ID:R327438