Job Details
Location:
Jalan Selangor, Section 52, PJ State, Petaling Jaya, Petaling, Selangor, 46200, Malaysia
Posted:
Jul 26, 2024
Job Description
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Job Description
JOB SUMMARY
Responsible for providing overall strategic and managerial leadership for the Medical Affairs function for the LOC, including strategic prioritization on projects and tasks in partnership with Takeda’s business stakeholders. He/she will contribute to the achievement of business success by putting the patient’s needs and safety into primary focus.
The Head of Medical Affairs will drive alignment across the Medical Affairs team, provide supervision for team members, and collaborate with key cross-functional stakeholders (e.g. compliance, marketing, commercial, and regulatory) across all Therapeutic Areas.
This position is responsible for planning and implementing medical strategies and tactics, to increase the understanding of Takeda products amongst healthcare professionals in the region.
This position will represent Takeda’s medical / scientific image among industry and health care practitioners and entities.
This position is a corporate office based position with people management responsibilities.
PRINCIPLE ACCOUNTABILITIES
Overall
- Responsible for the overall medical function in the Local Operating Company (LOC) including strategic planning, resourcing, and budgeting
- Provide medical expertise, governance and leadership to the Medical Affairs team
- Leverage strong science to create compelling strategies that fulfill unmet medical needs, support successful product registration, and increase availability of Takeda’s medicine to patients
- Represent the Medical Affairs function to senior cross- functional leadership as well as external stake-holder
Corporate Governance
- Oversee and ensure compliance of all responsible activities to relevant laws and regulations as well as internal standards and SOPs
- Serves as final signatory for medical approval of promotional materials for scientific meetings, symposia and other Medical Education activities, in accordance with applicable Codes of Practice and regulations as well as Takeda policies, within defined timelines
- Ensure patients have access to life saving products whilst strictly complying with Takeda SOP’s and code of conduct as well as MYSG Pharmaceutical Code of Ethics and applications, with an aim to comply with whichever code is stricter.
- Actively participate in local pharmaceutical industries association / societies committee meetings and analyze regular industry correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues
- Enhance the company reputation and profile through an external focus, by representing the company on cross- company boards
External Stakeholder Management
- Responsible for representing Takeda by providing an expert medical voice with external stakeholders as needed
- Establish ongoing relationship with key opinion leaders (KOLs), government officials, healthcare organizations and ensure that significant developments in the field are identified and monitored
Cross Functional Collaboration
- Ensure that string working relationships are fostered between Medical Affairs and other departments.
- Provide updates to senior management on Medical Affairs activities including status of clinical programs
- Collaborate with local senior management to develop strategic product plans to ensure timely entry of new products to the market and the ongoing market success of existing products
- Enable and support a positive team environment both within the medical team and with cross-functional stakeholders and drive employee engagement.
Clinical Research
- Collaborate with clinical development teams and provide medical expertise to development as needed
- Provide leadership and medical expertise in the development of clinical research programs in line with global strategies to support local product registration and marketing
- Develop and support local data generation programs to support product registration and marketing
- Proactively and reactively collaborate with clinical operations to ensure local patients are included in global trials as well as patient recruitment targets are met
Patient Centricity
- Responsible for medical leadership in planning and implementing patient access programs as needed, as per local regulatory requirements, and in line with Takeda policies
- Provide medical expertise in the review of adverse events locally and contribute to global pharmacovigilance activities as needed
- Ensure patient safety is prioritized and that adequate QA and PV systems are installed and implemented
- Coordinate QA- and PV-activities and ensure QA- and PV- SOPs are in place and are strictly followed. This includes managing product related medical safety issues and provide input on product-related quality issues and incidents to the global PV-team
Structural Organization
- Responsible for the financial management of the R&D program and medical plans, including budget planning, resource allocation and preparation of monthly / quarterly reports
- Ensure effective team communication and alignment throughout the Medical Affairs team
EDUCATION, EXPERIENCE, AND SKILLS
Education
- A medical degree is preferred.
Required Experience
- 10 years of Clinical or Medical Affairs experience in pharmaceutical industry
- Preferred experience supporting Vaccines TA / Portfolio.
- 5 years+ experience in people management
Preferred Experience
- High reputation in industry with established network
- within the Medical Affairs community that will attract high- calibre professionals into the organization
- In depth experience of Medical Affairs with quality achievements in life cycle management of medicines.
- In depth experience in clinical development and data generation including real world evidence, regulatory, market access and drug reimbursement process where applicable.
- Business Development experience from Medical Affairs perspective.
Skills & personal characteristics
- Excellent leadership, managerial, interpersonal and relationship building skills
- Solid people management skills and a desire to develop team members
- Highly collaborative, confident and strong executive presence
- Strategic thinker, innovative, able to drive multiple- simultaneous initiatives, able to work under pressure
- Able to drive consensus across diverse stakeholders to achieve goals
- Ability to identify and proactively addresses issues before they reach crisis points
- Goal oriented, focused, energetic, and enthusiastic
- Passionate and committed in all undertakings
- Excellent verbal and written communication skills in English; fluency in other languages is a plus
- Excellent presentation skills
- IT savvy and process orientated
- Good knowledge of healthcare systems
- A high level of knowledge of regulatory environment including key regulatory agencies and approval processes relevant to the country
Travel requirements
- Ability to drive or fly to various meeting sites
- Frequent overnight travel, including weekend commitments
Locations
Selangor, Malaysia
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time