Offers “Gsk”

Expires soon Gsk

Global Medical Affairs Manager, Zoster

  • Rockville (Montgomery County)
  • Personal services

Job description

Details:
Support the development and implementation of the Global Medical Affairs Strategies in preparation for launch of a candidate subunit adjuvant vaccine for herpes zoster in the US and Canada, by providing medical support and compose cross-functional teams within the organization.

Accountability:

• Knowledge and application of the GSK Code of Practice, Scientific Engagement and applicable Policies and SOPs in all areas of Medical Affairs

Strategy:

• Help implement the Global and Local Medical Plans (MPs), offering input from global gap analyses, key LOCs (Local operating companies) and/or regional input, as well as stakeholder and customer input (external and internal)
• Integration and alignment of relevant global and local Regulatory, Clinical, Epidemiology and Health Outcome activities and provides medical support / advice in collaboration with the Global Medical Affairs team to these plans
• Support integration and alignment of the medical affairs strategy and plan with the Launch Excellence Process in the US and other key countries under his/her accountability
• Participates and provides medical input to various meetings including: Vaccine Developments/Commercialization Teams, Internal medical training/ updates, Commercial meetings, Business and Development Intelligence meeting/activities etc.
• Contributes to the interpretation of the clinical / R&D / H-E / Epi data to provide medical input to development, scientific communication and commercial strategy and materials
• Helps driving harmonization of key wordings / vocabulary used (e.g. on safety) across different projects

Scientific Communications:

• Under the supervision of the GMAL and GMAD, deploys the medical communication strategy for the product including long term communication / publication planning
• Co-development and implementation of the integrated medical communication plan, including medical leadership of the secondary publication plan
• Ensures that medical/ scientific communications are scientifically sound and aligned with strategy from a medical perspective
• Critically appraises, review and recommends changes to publications, commercial and clinical documents for alignment to strategy, clarity of messages and scientific accuracy

External:

• Support the implementation of the External Expert Engagement Plan within the MP and implements the activities assigned in alignment with Scientific Engagement principles and relevant GSK policies and principles; external activities could include Advisory boards, External Speakers Programmes, Medical education, Medical round tables, HCP meetings
• Be an additional medical voice of GSK, able to represent the medical affairs team externally according to the level of experience and audience
• Demonstrates professional and ethical attitudes in External Experts (EEs) interaction and in EE development activities
• Contributes actively to the success of congresses by fulfilling identified roles, including interpreting scientific information related to the field of responsibility, active contribution in delivering the congress report, active representation of GSK and of the product at the congress and pre-symposia planning activities. Assist in the preparation of presentation of GSK data during GSK satellite congress symposia or scientific sessions
• Help implement the agreed elements of the EE Plans, works in collaboration with the medical operations team, LOC medical teams and related stakeholders to fulfill strategic needs
• Assists in the maintenance of professional relationships with External Experts in full respect of Scientific Engagement Principles
• Under the orientation of the GMAL or GMAD, manages agency partners, including setting agency brief, as appropriate - this activity may be managed in part by Medical Operation Managers directly, depending on the service being provided and who is driving the content

Internal:

• Provides medical insights and collaborates with cross-functional teams working on the assigned GSK product
• Provides medical training at internal meetings for the relevant product and therapy area to GSK Regional/ LOC medical teams
• Robust knowledge of data and literature related to the product/project; identification of important publications for communication to medical network and project team, preparation of position papers, rebuttals, feed-back on literature selection
• Actively contributes to the development of Medical Affairs processes and harmonization activities
• Accountable for providing medical advice to commercial partners in the development of Key Claims and promotional material, ensuring in particular, balanced and proportional content, appropriately referenced, and aligned with product strategy
• Conducts medical review and approval of promotional material in line with the Code of Practice and other relevant SOPs

Problem Solving:

• Ability to analyze scientific data (clinical, HE, Epi) and draw critical insights to understand how these address existing data gaps
• Where critical gaps exist, help defining these gaps in a manner that clinical, epidemiology and health outcomes partners can design appropriate studies to address
• Ability to communicate complex technical data to a wide variety of audiences, including vaccine implementers, prescribers and global experts
• Ability to identify the most appropriate paths of scientific communications that meet audience needs, and are consistent with GSK principles of Scientific Engagement

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
•Advanced Degree in life sciences, immunology, vaccinology, infectious diseases, public health and/or epidemiology
• 3+ years recognized experience and expertise in medical affairs and teamwork. Ideally includes experience managing external experts and interacting with EE's and organizing activities involving EEs
• Good communication and public-speaking skills are a must

Preferred qualifications:
• PhD, MD Degree, or PharmaD
• Understanding of the ethical, regulatory, compliance and legal framework which and knowledge of the issues that face Pharma Industry with respect to interactions with External Experts are an asset
• Knowledge of the Pharmaceutical and/or Vaccine Industry; understanding of the different disciplines involved, with knowledge of life sciences & vaccination: vaccines, infectious diseases, immunology, preventive medicine and public health is highly desirable
• Local affiliate experience (LOC)
• Specialty in immunology, infectious medicine, epidemiology or other relevant specialty is considered an asset
• Scientific and medical knowledge/expertise in designated disease/product area acquired through education, readings, daily work, attendance to meetings (internal and/or external), and attendance to congresses
• Basic knowledge of budget and account management
• Proficient in using a PC and common software packages (Word, Excel, Powerpoint).

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