Medical Affairs

2 days ago

คลองเตย กรงเทพมหานคร, Thailand PRTR Full time

PRTR is working with a company in the Pharmaceutical industry. They are now looking for a Medical Affairs & Compliance Assistant to join their team.

**Job description**:

- Being a single point of contact (SPOC) for Compliance, providing support on compliance consulting, and proper pharma policy/SOP to both local Medical and Commercial teams who interact with the relevant stake holders.
- Managing the implementation of the local initiatives to ensure all initiatives serve solely for the purpose of compliance with applicable laws, codes, rules, regulations and ordinances, and collaborating with regional and other country COs (compliance officers) to handle compliance queries and concerns from both local Medical and Commercial teams.
- Being a Quantum Connect (QC) super user, performing Quantum Connect (QC) data quality checks to ensure data entered by both local Medical and Commercial Quantum Connect (QC) team members/users is consistent, accurate, and ready-for-use, and, conducting Quantum Connect (QC) system training for local team members/users.
- Being a Creator for the Quantum Connect (QC) approval process for medical initiatives, collaborating with, and supporting medical teams with implementing medical initiatives such as: Medical Advisory Boards and educational events, etc.
- Being a Local Data Steward (Thailand) for Healthcare Organization (HCO), Healthcare Professionals (HCP), Patient Organization (PO) etc. profiles in the MDG system.
- Being a PDCS Program Lead - Company TH webpage, PSP Saizen, PSP Rebif, and PSP Mavenclad.
- In collaboration with the Regional Compliance Officer and Country Medical Director, being responsible for developing and managing a self-development plan according to responsible area goals and objectives.
- Ensuring Quantum Connect (QC) operational excellence by sharing best practices.
- Conducting Code of Conduct and Biopharma policy and compliance training for new hires.
- Recognizing and reporting on adverse events (AE), special situations, or other pharma related information and ensuring the necessary information is forwarded according to the company procedures.
- Obtaining and compiling information regarding the receiving of complaints, and transferring to the Quality Manager.

**Qualifications**:

- Bachelor degree in any field.
- English ability to communicate within the organization.
- Good presentation skills.
- Interpersonal skills - ability to communicate in a precise, reliable, unambiguous, and timely manner.
- Time management skills - ability to complete tasks in an accurate and timely manner, and to effectively manage multiple tasks.
- Problem solving skills - proven ability to perform under pressure and remain positive and motivated.
- Ability to set priorities, and identify and mitigate risks.
- Accountability for all assigned tasks.

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