Associate Director Medical Affairs Indonesia

IDN - 2710 PT Takeda Life Sciences; Pluit; On-site; IDR 3,000,000,000 - 6,000,000,000; Full time

Job summary

Takeda Life Sciences Indonesia seeks an Associate Director Medical Affairs to lead medical governance, regulatory compliance, and clinical oversight for BioLife plasma centers in Indonesia, including donor safety and center physician oversight during pilots.

MD with Indonesian license and 8–10 years in healthcare/pharma are required, with leadership experience and strong English/Bahasa Indonesia communication. Travel across Indonesia and international capability building may be required.

Qualifications

• MD or equivalent with full license to practice medicine in Indonesia.
• Board certification or specialization in Transfusion Medicine, Hematology, or related discipline preferred.
• 8-10 years medical experience, including 3-5 years in leadership/advisory role within healthcare, plasma collection, or 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.

Responsibilities

• Medical Governance & Oversight: Serve as local medical authority for all BioLife plasma centers in Indonesia and ensure donor safety and plasma quality.
• Regulatory & Compliance Leadership: Lead medical documentation for licensing and inspections, ensure GMP/GCP compliance, support audits and inspections.
• Medical Consulting & Advisory: Provide medical input to Country Head and operational teams; advise on policy and process changes.
• Training, Development & Support: Train and mentor center physicians and medical staff; oversee education and SOP implementation.
• Pharmacovigilance & Hemovigilance: Oversee adverse donor events reporting and follow-up.
• Representation & Collaboration: Represent BioLife Indonesia in medical forums; align with regional/global teams.

Skills

Medical & Regulatory Expertise

Strategic Advisory

Leadership

Ethical Practice

Analytical Thinking

Communication

Collaboration

Education

Medical degree (MD or equivalent) with full license to practice medicine in Indonesia

Job description

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:

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):

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.

Locations Jakarta, Indonesia

Worker Type Employee Worker

Sub-Type Regular Time Type Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.