Group Lead, Medical Review Expert Group (Sr. Manger)

Position Purpose
This role is a key Line Manager of the Medical Review Excellence (MRE) Group by acting as a key partner to in-country Medical Affairs, Marketing and Regulatory colleagues. This role aims to minimize compliance risks by ensuring review and approval of promotional and non-promotional materials as well as Medical to Medical content in conformity with all applicable country law, regulation and industry code. As an active thought leader and medical processes partner, this role will also draw upon best practices to identify new ways of working and drive continuous improvement that generates value for medical colleagues in-country.
Execute the quality management and compliance for the promotion/non-promotion materials
• Provide critical scientific input to required review documents with predicting future medical needs from the perspective of actual clinical practice and understanding the status of competing products and other treatment
• Ensure that all the materials are compliant with the global and local regulation and internal SOP through reviewing scientific perspective in promotional and GVP materials by Pfizer are created in a right way in accordance with the internal policy, REG08, and external regulatory rules, such as JPMA's rule (codes of practice), MHLW GL, Pharmaceuticals and Medical devices law.
• To work in collaboration with cross-functional team(s) on preparation, review and approval of training materials for colleagues
• Collaborate with Global MRE and Medical Affairs colleagues
• Align basic concept, local activities and input local considerations to Global MRE
• Establish local supporting documents, Local Procedure based on aligned/collaboration with Global MRE
• Lead to resolve local issues as 1 global direction by close communication/ negotiation with Global MRE Leaders
• Contribute global common matters as local lead in the Global MRE leadership team
Cooperation with internal and external stakeholders for the promotion/non-promotion material preparation
• Play a leading role in close communication with senior Leaders across BU (looks like SLT, MLT and MALF governance) and/or the product teams to share information about promotion materials related issues in an appropriate manner and to resolve critical level of violations/ deviations as a company issue
• Lead internal stakeholders to resolve an Audit findings /compliance/quality matters regarding to the science and medical and also be an internal medical consultant for medical related issues
Collection of latest scientific knowledge and contribution for the material review based on the knowledge
Collaborate with the product team and check/improve the review process
Lead/Management role
• Mentor/oversee the mentorship of staff, ensuring they achieve competency standards and are provided with appropriate career development opportunities.
• Provide administrative and technical oversight of the group.
• Implement organizational design and develop succession planning for the group.
Organizational Relationships
Global MRE/MEI, Medical Affairs, MI, MQO, Legal, Compliance, Safety, Development Japan and Business Units, other functions.
Resource Managed
Direct Report 7-10
REQUIRED SKILL SET
• Technical
• Have a motivation to contribute a product/disease from medical and regulatory science and compliance
• Excellent scientific thinking and judgment skills based on basic medical knowledge and experience of the disease area.
• Ability to understand,analysis an impact through reading peer-reviewed medical papers (in Japanese and English).
• Advanced knowledge of Statistics, Study Design and Operational procedure for Clinical research
• Understand compliance and related various regulations and/or experience
• Excellent communication, negotiation, proactivity, cooperativeness, and influence skills
• Excellent planning, discussion and presentation using project management skills
• Ability to make and implement proposals based on strategic thinking, logical thinking, and creative/innovative thinking.
• Managerial
• Strong leadership capabilities including the ability to drive strong followership in reporting line
• Skilled negotiator and influencer, comfortable with implementing change
• Effective communication skills in relating to colleagues and associates both inside and outside the organization
• Ownership: keep having strong ownership to achieve goals. Leads changes and acts decisively
• Decisive decision making, cooperativeness, good influence, well-organized, coping with difficulties with strong will/brief
• Flexibility and implementing change: Respond positively and constructively to changing situations and manages change by identifying opportunities and coaching self and others through the change
• Understand the challenges on the business environment internal/external company, and strategically enhance and improve the quality of processes and deliverables.
• Education
• Level at which s/he can discuss, debate, negotiate with global colleagues or external customers (More than TOEIC 730 at least)
• 4 year university undergraduate degree AND master's degree in life science, or
• Pharmacists
o 4-year university graduates with pharmacist license and master's degree or equivalent life science research experience, or
o 6-year university graduates with pharmacist license, or
• Nurses with master's degree, or
• Veterinarians, or
• Dentists, or
• MDs
Preferred
In addition to those who meet the minimum requirements above, the qualifications below are preferred:
• MD (clinical experience, board certification preferred)
• PhD in Life Science
• Experience
• Experience as a line manager
Preferred
• MA/DJ experience and / or research experience
• At least 10-year experience in the pharmaceutical fields (medical is preferable) or equivalent.
• Experience as a decision maker to matters under regulatory requirement
• Experience of project management in cross functional tasks
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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