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Medical Manager

応募 後で応募 求人ID R0007391 掲載日 02/26/2019 Location:Manila, Philippines

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Job Description

Job Title: Medical Manager

Reports to: Medical Director

Department: Medical Affairs

Overall Job Description: 

The Medical Manager provides medical expertise and support on matters relating to Therapeutic Area(s)/ Takeda products of responsibility to Marketing, Sales and other internal stakeholders. The role supports the Medical Director in establishing the local Medical Strategy Plan and its implementation for the TA of responsibility and ensures the correct interpretation and communication of scientific data on the Company's products. The Medical Manager also advocates patients' needs and safety.

Primary Duties and Responsibilities

Medical/ Scientific Affairs

  • Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate
  • Present the clinical evidence to internal and external stakeholders in a non-promotional way 
  • Assess scientific accuracy and validity of non-promotion material and its compliance with Takeda standards, SOPs and national laws
  • Communicate and align with Regional and Global Medical Affairs functions
  • Develop local strategic medical plans in line with product Life Cycle Management plans and oversee execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.)
  • Establish and maintain strong relationships with Key Opinion Leaders (KOLs)
  • Act as communication link to authors of scientific publications about Takeda products
  • Provide extensive, clear and structured briefing to external presenters/speakers at Takeda sponsored medical events, e.g. local Advisory Boards, doctors’ meetings
  • Identify gaps in the local clinical study program which are a hurdle for successful regulatory and/or clinical acceptance of the product and propose studies to address these issues
  • Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance/LOC Market Access
  • Evaluate and support local investigator initiated research proposals in alignment with global strategy and Takeda standards and SOPs
  • Budget responsibility for medical affairs activities related to TA/product
  • Other medical and scientific support duties as assigned
  • Provide medical training for allocated therapeutic area / products to Marketing & Sales
  • Provide scientific input into Marketing strategy and tactics
  • Provide medical input for development of promotion material
  • Assess scientific accuracy and validity of promotion material and its compliance with Takeda standards, SOPs and national laws and regulations

Medical Information

  • Responsible for the Medical Information System of Takeda Healthcare Philippines, Inc.
  • Responsible for responding to unsolicited requests
  • Screens all inquiries received for potential adverse events or product complaints, and documents according to local MIS procedure, including confirmation that the request was unsolicited.
  • Responds in a timely fashion (targeting 5 business days), avoiding medical opinions or treatment recommendations not in the label, and consistent with local regulations and laws.
  • Escalates queries to regional and/or global MIS as needed

Clinical Development

  • Develop study outline and protocol for local post-authorization (phase 4) studies sponsored by Takeda; coordinate/oversee study conduct, data analysis and disclosure, reporting/publication
  • Liaise with CROs and other vendors for Takeda sponsored global studies as appropriate
  • Collaborate with Global Development Operations functions (e.g. LOC Support)

Pharmacovigilance

  • Assist in the conduct of Pharmacovigilance activities
  • Keep up-to-date on local drug safety legislation

Other Tasks in Job

  • Share knowledge within the therapeutic area
  • Active participation in cross functional/organizational projects
  • Ensure up-to-date knowledge through participation in relevant courses and meetings and through reading of relevant literature, regulatory guidelines and news media
  • Ensure that responsibilities are carried out in compliance with SOPs and GCP
  • To perform other tasks and duties which may be assigned by immediate supervisor

Qualifications, Competencies and Attributes

  • Medical Doctor
  • At least 2 years of relevant clinical practice, research, academic and/or

    pharmaceutical industry experience

  • Medical expertise across a broad spectrum portfolio would be appreciated
  • GCP- certified
  • Experience with clinical research, publication activities, congress

    presentations, and public speaking

  • In-depth understanding on Philippine Regulations
  • Ability to liaise with KOLs and establish relationships
  • Ability to proactively seek solutions in collaboration with Marketing teams
  • Good knowledge of the international and local health care market, able

    to identify healthcare trends

  • Proficient communication skills

  • Strategic thinking and decision- making acuity

  • Excellent collaboration skills; a team player

  • Strong conflict- management/ problem-solving insight

  • Unquestionable personal and business integrity

Locations

Manila, Philippines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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