Business Practice Specialist

Job Description

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia

• Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.

Business Practice Specialist

In reporting to the Business Practice Leader, the Business Practice specialist supports the localization, implementation and reporting on country compliance processes.  The position works with 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.

In working with the Country Business Practice Leader, the Primary Activities and Responsibilities include but are not limited to:

Implementation of Key Processes and Systems  

• Working with BPL to coordinate the Country Compliance Committee Meetings and processes;

• Attend global and regional team meetings to ensure on the latest development and the updates and changes of policy development ie. AP BPO meeting and the monthly Global BPM  meetings.

• Responsible for the overall Patient Program system administration and process;

• Working with BPL to conduct 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;

• Timely renewal and monitoring of local SOPs renewal;

• Review 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 support for relevant Company or other Audit programs;

• Support global/regional system implementation as data source liaison (e.g. GO Verify, Empower BI and Aravo;

• Conduct or oversee the Compliance team in their day to day management of Compliance Business Support Activities (e.g. Veeva event reviews; ABC activities, etc.).

Tracking and Monitoring

• Support Compliance Scorecard achievement through monitoring and follow up of KPIs;

• Assist and conduct monitoring and perform regular self-audits of systems and processes (e.g. Empower BI, Go Verify, Aravo, Whatsapp Backup, Privacy Inventory, etc.) to identify gaps, and ensure follow up with the business of required actions and documentation;

• Prepare regular monitoring reports and minutes for Country Compliance Committee Meetings;

• Support audit and Privacy Annual Certification remediation follow-up to ensure audit findings are resolved in a timely way and effective controls established;

• Assist with the collection of data for HQ reports.

Training and Communication

• Support and execute effective compliance training and communication programs, including classroom based train-the-trainer programs (e.g. new manager hires, new SOPs), GCTO, COI certification and other country-specific training requirements (e.g. new systems, audit remediation, Compliance refresher training and onboarding training for new hires).

Business support & feedback

• Provide advice and directing local request for policies and ensuring stakeholders equipped with the knowledge to look up on our company policies and procedures;

• Work together with BPL for consultation on regular business activities and programs with stakeholders;

• Ensure consistent implementation of global / regional compliance policies;

• Ensure documentation is complete and kept properly at subsidiary level. 

• Having a sense and health-check the Country’s compliance culture in consultation with the country BPL,

• Report and discuss with BPL and Legal & Compliance for any significant compliance concerns or issues for appropriate corrective actions to be taken.

Knowledge of Regulations and Compliance

Understands and applies knowledge of international, federal, and organizational or corporate policies, regulations, procedures, laws and processes to achieve results.

• Internal policies, procedures, etc.

  • Knows where to go to find various forms of information/guidance;

  • Demonstrates in depth understanding of policies/procedures relevant to different parts of the business;

  • Can interpret the letter and spirit of policies, etc., into 'practice' for business partners;

  • Uses knowledge and displays confidence in effectively helping business partners comply with policies/procedures.

Effective Communication

Effectively presents information and concepts, in both written and oral formats.  Actively listens and openly receives feedback to ensure understanding.

• Listens effectively and gathers appropriate input to understand different situations and views to define and dissect complex issues, to achieve resolution or define a clear path forward, by:

  • Demonstrates to business partners an understanding of what has been heard from them (e.g., through summarizing the details, what the objectives are, etc.), and what the intent is (in spirit and letter) of new business initiatives that are being proposed;

  • Asking clarifying questions as needed;

  • Clearly demonstrates that there are no 'pre-conceived' opinions, but are listening to the input from the business;

  • Clearly articulates rationale to help stakeholders understand recommendations.

Monitoring

• Periodically review local monitoring/control processes for risk areas;

• Coordinate pre-audit and audit activity; follow up remediation actions post-audit;

• Coordinate Medicines reporting & audit activities; follow up remediation actions post-audit;

• Conduct or oversee due diligence evaluation on individuals in accordance with anti-bribery/FCPA requirements;

• Conduct or oversee documentation for other programs/activities (e.g grants/ donations/ sponsorships).

WHAT YOU MUST HAVE

PERSON SPECIFICATIONS

Essential

Education

University Degree in Science or Business preferred

Training and Certification

Business experience

Communication & Compliance background

Experience

• Compliance background

• Experience in business or training departments

• Strong Collaboration skills

Language Requirements

Excellent Oral, Written & Presentation Skills in English

What we look for…

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us — and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:10/13/2024

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:R313060