21 days old

[MA] I&I MA Lead Japan

Pfizer
Tokyo
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**About Pfizer**

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people.



Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Right now, we are seeking highly qualified candidates to fill the following position in Tokyo, Japan



Inflammation and Immunology Medical Affairs Lead Japan (m/f)



This is what you can look forward to:



+ In this position you provide leadership to dedicated medical affairs team

+ You will be responsible for development of the Medical Plan and Strategy for inflammation and immunology

+ You will be a member of the Country Medical and the Inflammation and Immunology cross-functional Leadership Team

+ You ensure compliance of medical team with country Code of Practice and relevant procedures, regulations and guidelines

+ In addition, you will work closely with internal and key external stakeholders including Japan PMDA supporting

+ Pfizer strategy and bringing medical insights as well as support for media, government and patient group activities, including policy development, corporate initiatives and issues management

+ You will take accountability for reviewing and certificating promotional and non-Promotional materials

+ Giving input into HEOR submissions, HTA dossiers, clinical guideline consultations andregional formularies

+ Closely collaborating with Development Japan by providing input on development and regulatory strategies

+ Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals

+ You will collaborate closely with the Country Medical Director as well as the relevant platform functions such as Regulatory Affairs, Drug Safety, MQO, Medical Operation, Medical Information, Medical Grant Management, , Compliance, Legal and Product quality to ensure adequate external representation



What you offer:



+ A Medical Doctor degree, with knowledge in inflammation and immunology (gastro, derma or rheuma specialty preferred)

+ You have significant pharmaceutical industry experience and excellent understanding of the local healthcare environment. Significant management experience in other health care industry also valued

+ You are qualified to act as in country signature, or have qualifications and potential to become a medical signatory

+ Additionally, you have a good knowledge of pharmacovigilance, regulatory legislation and drug development

+ You have a strong people management and leadership skills and excellent business acumen

+ Furthermore you have fluent language skills in Japanese and English



In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.



ROLE PURPOSE



+ To lead a medical affairs team who:

+ Support the development programs and life-cycle clinical plans for Pfizer medicines

+ Communicate the safe and appropriate use and the value of Pfizer medicines in order to improve patient outcomes, enhance clinical practice and support business needs at the national, regional and corporate level

+ Work with key external stakeholders during the life-cycle of Pfizer medicines, bringing their insights to the organization to shape strategy and providing focused, relevant information in response to their needs

+ Ensure promotional and non-promotional activities and materials are in full compliance with country codes and related Standard Operating Procedures and Guidelines



KEY ACCOUNTABILITIES



+ Leadership of medical team, including setting business objectives, performance management and team development

+ Responsibility for development of the Medical Plan/Strategy for relevant therapeutic areas

+ Recruitment, development and retention of talented colleague

+ Coaching and guidance of colleagues to support them achieving their maximal potential

+ Membership of Medical and Commercial Leadership Teams

+ Resource allocation to ensure appropriate resources to fulfil medical objectives and business needs

+ Ensure compliance of medical team with country Code of Practice andrelevant SOPs,regulations and guidelines

+ Collaboration with internal stakeholders to ensure timely receipt of information on brand strategy, clinical plan, new clinical data, new regulatory and safety information and accurate, balanced and up to date materials to use in medical to medical communications

+ Work with key external stakeholders during the life-cycle of Pfizer medicines, supporting Pfizer strategy and bringing external insights to the organisation to shape strategy and providing focused, relevant information in response to their needs

+ Review and certification of promotional and non-promotional materials and activities and approval of customer engagement programs

+ Ensure that product materials and related activities reflect the most up to date regulatorylabelling and risk management plans and regulatory commitments

+ Input into regulatory submissions, clinical overviews, licence variations and CDS updates as required

+ Input into HEOR submissions, HTA dossiers, clinical guideline consultations and regional formularies as required

+ Input into assessment and due diligence of business development initiatives

+ Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals related to portfolio

+ Support for in country clinical research programs, including protocol and site feasibilities related to portfolio

+ Protocol approval and oversight of in country non-interventional studies related to portfolio

+ Support for investigator initiated research (ISR) studies to ensure that appropriate records are kept and progress is monitored

+ Support for media, government and patient group activities, including policy development, corporate initiatives and issues management

+ Participate in local, regional and global cross-functional project teams to ensure that ongoing improvements in processes and performance are delivered

+ Accountable for medical team and headcount/expenses budgets

+ Represent the country and countries interests to regional and Global teams



SKILLS, QUALIFICATIONS, EXPERIENCE, COMPETENCIES:



+ Medical Doctor,, preference Board Certified

+ Qualifications to act as in country signature, or have qualifications and potential to become a medical signatory is mandatory

+ Significant pharmaceutical industry experience or management in health care industry

+ Excellent communication and presentation skills in English and Japanese

+ Ability to intercat at peer level with medical and scientific external community

+ Line management experience desirable

+ Experience in Inflammation and Immunology desirable

+ Excellent understanding of the local healthcare environment

+ Good knowledge of pharmaco-vigilance and regulatory legislation and how it impacts the product portfolio

+ Good knowledge of drug development

+ Business acumen

+ Ability to prioritize resources in line with brand and customer strategy

+ Team player

+ High degree of cross-functional leadership and collaboration

+ Communication and influencing skills

+ Role modelling, upholding values, adhering to standards, visibility

+ Leadership skill



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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Posted: 2021-03-29 Expires: 2021-04-29
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[MA] I&I MA Lead Japan

Pfizer
Tokyo

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