Pfizer
Medical Affairs Manager
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More information about this job


Location
Saint Paul, MN
Employment type
Full-Time
Pay
TBD/year
Job description

Department:      Research, Development and Medical, Upjohn (Established Medicine Business)

Position:               Medical Manager                

Reports to:         Upjohn Medical Lead, Thailand

Supervises / oRGANIZATION RELATIONSHIP

     

Upjohn Medical Lead, Country Medical Director

Responsible Business Unit team and Country Lead

Responsible regional team including Country Brand Lead

Clinical Trial Support and Compliance

Drug Safety Unit

Medical Information Unit

Regulatory Affairs team

Medical Quality Oversight Manager

Quality Assurance team

Outcomes Research Manager

Key Responsibilities

1.  Medical Affairs Function

  • Provides medical and scientific inputs for the development of launch plans, plans of action (POAs), and activities of responsible products
  • Provides scientific advices in the organization of major symposia and medical advisory board meetings
  • Provide medical supports for any medical issues related to responsible products
  • Provides medical comments/advices to concerned BU colleagues in developing relevant promotional materials and product advertising activities according to relevant SOPs
  • Provides medical inputs, including relevant document for the development of hospital formulary listing packages
  • Provide appropriate training on medical part of responsible products and related diseases
  • Continually updates sales staff on medical/scientific aspects of responsible products
  • Ensures consistent, balanced, and accurate responses to internal/external medical

information queries.

  • Provide scientific comments for submitted Investigator Initiated Research (IIR) from health care professionals, as per relevant Pfizer SOP and local processes.
  • Responsible for preparing study protocol, study budget,  executing study and completing the study report as a study leader for local clinical study.
  • Provides medical input on program/protocol feasibility surveys.
  • Provides medical input in completing Adverse Event report.
  • Provides medical input to local Outcome Research Manager on products and diseases within responsible therapeutic areas
  • Scientific discussion with investigator-author in preparing IIR study publication.
  • Reviews translated Local Package Documents (LPDs)/Patient Information Leaflets (PILs) to ensure accuracy and optimal medical standard of practice.
  • Reviews submission packages for unconditional approval by Thai FDA

2.  Functional Administration

  • Develops and initiates working system pertaining to responsible medical affairs activities in order to improve and enhance work efficiency
  • Handle correspondences-related with responsible medical affairs activities with overseas and local both internal and external parties
  • Ensures the maintenance of relevant medical affairs-related information/document/correspondence etc. in confidentiality, accuracy and easy retrieval system.

3.  Standard Operating Procedures (SOPs) and Company Compliance Regulation

  • Ensures and monitors the scientific parts of company educational activities such as Pfizer symposium/local educational program/speaker training program to be compliance with relevant SOPs and company regulation
  • Ensures the medical and scientific parts of promotional materials and product advertising activities of responsible products to be compliance with relevant SOPs and company regulation

4.  Medical Support/Advice and External Partnership

  • Develops and enhances partnership with relevant Medical Associations and Royal Thai Medical College
  • Liaises with key opinion-leaders to build rapport, when applicable
  • Provides guidance on Pfizer’s position against adverse drug publicity and issues
  • Assists Regulatory Affairs team in answering queries form local FDA staff and medical experts on registration dossier/labeling/safety/efficacy of responsible products.
  • Provides medical information, comments, advices, and recommendations to overseas

and local both internal and external colleagues.

  • Keep abreast of local medical regulation changes and ensures the company policy is aligned with those changes, if relevant
  • Maintains awareness of competitor intelligence and provides information to relevant BU colleagues

Education and Qualification

Education & Experience

  • Medical Doctor Degree or Advanced health sciences degree
  • At least 3 years clinical experience in a Thai medical practice, experience which
  • involves an understanding of marketing and business practices
  • Experiences in pharmaceutical industry will be useful (clinical development processes, project management experience in the clinical development or medical affairs area)

Desired technical and behavioral skills:

  • Clinical and regulatory processes
  • Training delivery
  • Project and processs managment
  • Presentation and influencing skills
  • Understands stakeholder needs
  • Strategic thinker
  • Innovation
  • Influencing
  • Networking
  • Courage with decisiveness to act
  • Costumer focus
  • Decision making

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

About Pfizer
At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.
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Medical Affairs Manager