Job Title: Head of Medical and Regulatory Affairs
Report to: Country Head, Taiwan
Our client in this search is a global biopharma company
Purpose of This Role
The Head of Medical and Regulatory Affairs provides medical and regulatory input, guidance and coordination to support to sales, marketing, clinical, and medical affairs departments in responsible countries in order to contribute to the achievement of strategic business objectives. He/she is accountable for leading and managing medical/regulatory team and new medical, scientific, and clinical trial and communication initiatives that will support and help deliver medium and long-term profitable business growth, maintaining and optimizing existing registrations for all assigned Company product licenses and to have in depth knowledge of national regulatory regulations and legislation, within the strategic framework of the Company Group and ethics and compliance requirements.
Ensure optimal Medical affairs for Company products
- Plan, develop and implement cross-functionally aligned medical affairs and regulatory plans in order to ensure that the company achieves strategic business objectives and financial goals of Company
- Manage, guide, animate and inspire Taiwan medical and regulatory team by setting and delivering ambitious and challenging objectives to support the strategic business intent.
- Create and nurture professional relationships with key local opinion leaders, scientific decision makers (including institutional bodies) and develop and assist in the implementation of Taiwan KOL management program. This will include be out in the field frequently
- Provide medically and scientifically accurate, current and timely information on all Company products to internal and external requesters, and provide strategic input to product plans
- Ensure the delivery of timely and accurate medical training to internal staff to ensure a high level of medical knowledge and understanding within Taiwan that is aligned with Company requirements and relevant standards
- Ensure that Company medical, pharmacovigilance and quality SOPs and all corporate policies are received, understood and followed by Taiwan medical team
- Support Market Access providing relevant clinical and HEOR data to support optimal access and reimbursement conditions for Company products in Taiwan
- Partner sales and marketing objectives at clinical visits, congresses and other meetings and provide active input into account plans
- Supervise regulatory activities under the responsibilities of regulatory officer (quality assurance and control, registrations affairs, promotional material validation, etc.)
Supervise and successfully manage execution of clinical studies
- Propose clinical centers for participation International studies
- Ensure appropriate design, monitoring and reporting of local clinical & epidemiological studies
- Act as key contact person for the HQ Clinical Operations and/or for the contracted CRO companies
- Lead and supervise proper execution of Grants and Externally Sponsored Studies
Demonstrate ethical behavior
- Comply with Company SOPs, guidelines and country/industry standards
- Lead compliance strategy and execution
- Lead and master implementation of the Company and local association ethical codes
- Verify and approve all promotional materials where appropriate
- Ensure that clinical studies and pharmacovigilance/complaints monitoring and reporting is provided in compliance with Company SOPs and national regulations for all actual and future Company products in close collaboration with regulatory
- Stay fully updated on applicable regulatory requirements such as GCP, ICH, GPvP, GPP3 Company SOPs, company policies and Industry Codes of Practice
Organization and people development
- Design and lead optimal medical & regulatory affairs organization, ensure continuous Business model adaptation to changing market and environment
- Ensure recruitment, motivation and development of staff
- Assess and reward performance based on clear objectives (IPAP)
- Align and energize team around common objectives.
- Develop Leadership and Change capacities of the management team.
- Ensure retention of key people
Required Education and experience:
- Medical degree, (specialization in oncology/specialty care preferred). At least 3 years’ experience in the pharmaceutical industry and at least 5 years’ experience in hospital practice
- Excellent verbal and written English.
- Oncology/ Urology/ Endocrinology KOLs knowledge would be a plus
- Knowledge of, and current training in, international/ local studies and GxP (GCP, GPvP, GMP, GDP, and other applicable Instruments and Regulations governing clinical research.
- An understanding of the drug development process and a good knowledge of the therapeutic area would be a strong advantage.
- Demonstrated experience in successfully influencing a cross functional team of people ( a mix of experience, skills sets and roles) in Taiwan or International setting
- Ability and willingness to undertake regular travel for field visits across Taiwan, Asia and other countries as required
- Strong leadership, organization, communication and influencing skills
- Strategic thinking (e.g. understand KOL needs, identify issues and opportunities, develop targeted multifaceted solutions, find ways to operate differently by focusing on high added value tasks)
- Demonstrated capacity to build strong relationships across functions and to work closely with all people across the business
- Knowledge of Taiwan legislation related to given area of responsibility and industry ethical codes
Qualified and interested Parties please apply with your CV in Word format to firstname.lastname@example.org. You can also reach Patty at +886-2-2757-7268#222
Please note, that while Morgan Philips welcomes and appreciates all candidate response, volume of replies allows us to respond to short-listed candidates only. Resumes are collected for recruitment purposes only.