Associate Director Medical Affairs Indonesia
Takeda · Jakarta
Job Description
Objective / Purpose: The Associate Director Medical Affairs Indonesia serves as the primary point of contact for all medical and regulatory matters related to BioLife plasma operations in Indonesia.
This role provides expert medical oversight, ensures compliance with national health and plasma collection regulations, and offers strategic medical guidance to support BioLife’s market entry and expansion. The Associate Director Medical Affairs Indonesia acts as the local medical authority, responsible for ensuring the safety of donors, the quality of plasma collected, and adherence to Takeda’s global medical, ethical, and quality standards.
While not directly involved in routine clinical donor care, the Associate Director Medical Affairs Indonesia provides leadership, consultation, and governance for all medical aspects of BioLife's Indonesian plasma centers and supports the development of local medical teams and processes as the operation scales. During the pilot phase and subject to local regulatory requirements, the role may also support plasma center operations by serving as the designated center physician when required.
Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified.
1. Medical Governance & Oversight (≈30%)
- Serve as the local medical authority for all BioLife plasma centers in Indonesia.
- Ensure medical operations comply with Indonesian healthcare regulations, plasma collection standards, and Takeda/BioLife global SOPs.
- Oversee donor health and safety policies, medical protocols, and adverse event management.
- Maintain medical accountability for the quality and safety of plasma collected in Indonesia.
- During the pilot phase and subject to local regulatory requirements, provide medical oversight and support as the designated center physician for plasma center operations when required.
2. Regulatory & Compliance Leadership (≈25%)
- Act as BioLife’s main medical liaison with Indonesian health authorities and relevant government agencies.
- Lead the preparation and submission of required medical and regulatory documentation for licensing and inspections.
- Ensure compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and all applicable biosafety regulations.
- Support audit readiness and regulatory inspections in collaboration with Quality Assurance and Compliance functions.
3. Medical Consulting & Advisory (≈20%)
- Provide medical expertise and consultation to the Country Head, operational leadership, and functional teams.
- Advise on the medical implications of operational changes, new processes, or regulatory updates.
- Contribute to donor and plasma-related risk assessments, medical policy decisions, and process optimizations.
- Support medical input into expansion planning and new site set-up activities.
4. Training, Development & Support (≈10%)
- Provide training, coaching, and medical guidance to center physicians and other medical staff.
- Oversee qualification and continuous education of local medical personnel, ensuring compliance with both Takeda and Indonesian standards.
- Support implementation of medical SOPs and ongoing medical competence assessments.
5. Pharmacovigilance & Hemovigilance (≈10%)
- Oversee the collection and reporting of adverse donor events and post-donation information in line with global Takeda and local regulatory requirements.
- Ensure appropriate follow-up and documentation of donor-related safety incidents.
- Analyze medical and epidemiological data trends to support continuous improvement.
6. Representation & Collaboration (≈5%)
- Represent BioLife Indonesia in professional, regulatory, and medical forums.
- Collaborate with regional and global BioLife medical teams to ensure consistent medical standards and knowledge sharing.
- Support cross-functional collaboration with Legal, Quality, HR, and Public Affairs teams.
Education & Competencies (Technical and Behavioral): List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.
Minimum Education:
- Medical degree (MD or equivalent) with full license to practice medicine in Indonesia.
- Board certification or specialization in Transfusion Medicine, Hematology, or related discipline preferred.
Professional Experience:
- Minimum 8-10 years of medical experience, including at least 3-5 years in a leadership or advisory role within healthcare, plasma collection, or the pharmaceutical industry.
- Strong knowledge of Indonesian health regulations and familiarity with plasma collection or biologics manufacturing.
- Experience working with regulatory authorities and managing medical compliance matters.
- Prior experience in international or multinational healthcare organizations preferred.
Key Skills and Competencies
- Medical & Regulatory Expertise: Deep understanding of plasma collection standards, donor health, and medical compliance.
- Strategic Advisory Capability: Ability to provide expert guidance balancing medical, regulatory, and operational perspectives.
- Leadership & Influence: Builds credibility and trust with internal stakeholders and external authorities.
- Ethical & Patient-Centered Mindset: Ensures all medical decisions prioritize donor safety and ethical standards.
- Analytical & Decision-Making Skills: Strong medical judgment and ability to act decisively in complex situations.
- Communication & Representation: Excellent interpersonal and communication skills in English and Bahasa Indonesia.
- Cross-Functional Collaboration: Works effectively across regional and global functions to ensure alignment and compliance.
Other Requirements
- Willingness to travel across Indonesia to support plasma center training and audits.
- Commitment to Takeda’s values of Integrity, Fairness, Honesty, and Perseverance.
- Adherence to Takeda’s Code of Conduct and EHS and Quality standards.
- Willingness to travel internationally, including to the United States and Europe, for training, capability building, and knowledge transfer activities.