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Associate Medical Director, Medical Affairs

San Francisco Bay Area, CA

Posted: 11/02/2018 Job Category: Clinical: Medical Affairs Job Number: 2210

The Associate Medical Director, Medical Affairs is responsible for supporting Global Medical Sciences activities for an assigned product from pipeline through post approval status to support, and in alignment with Medical Sciences Global Medical Product Lead (GML) and Product Global Medical Plan. Key product responsibilities include, but are not limited to, alignment with commercial business partners, Global Medical plan development, product launch execution, promotional or scientific materials review and approval, KOL relationship management and medical monitoring of post-approval commitments.

RESPONSIBILITIES INCLUDE:
  • Product Strategy & Planning
    • Support the develop and implementation of the Global Medical Plans and medical activities in coordination with the Global Medical Lead (GML), Medical Affairs, Commercial and Regulatory colleagues
    • Ensure adherence to regulatory and clinical practice guidelines in supporting development and marketing of compounds
    • Act as a point of contact and product and disease area expert for all product or disease area related issues
  • Scientific Messaging and product marketing materials
    • Contribution in the creation of a scientific messaging platform and related promotional materials, response letters
    • Drive relevant publications on diagnostics, disease management and treatment guidelines and attend quarterly publication meetings
    • Review Medical Information request fulfillment, standard response documents and FAQs with sign-off responsibility where regulations require
    • Conduct medical review of promotional material to ensure maximum effectiveness while adhering to the company' s ethical standards and relevant Codes of Practice for the region
    • Participate in, and contribute perspectives to scientific messaging discussions 
  • Local Market key relationship and access development
    • Communicate with commercial teams on a regular basis to ensure appropriate medical/scientific support for marketing and sales initiatives
    • Participate in develop, management and maintenance of  KOL relationships in close collaboration with other MDs or MSL teams
    • Organize, attend, and if required, chair advisory boards
  • Product Launch
    • Develop launch plans in collaboration with Medical Affairs and Commercial colleagues and execute on the GMAF tactical launch activities in support of global product launch
  • Post Marketing – Registries, IR, observational
    • Support PMC/PMRs and studies falling under the GMAF scope in collaboration with the GML, study management lead when required; Assist study management team in medical review and input in Medical Affairs-run studies as assigned. Act as Medical Monitor for PMC/PMRs as needed.
    • Attend investigator meetings, as needed in alignment with Global Medical Plan objectives
    • Participate in Independent Research Program reviews as assigned
  • Product and Disease Training and Education
    • Assist in the training of new medical affairs and commercial recruits by presenting the scientific disease and product related data and present at sales conferences, meetings, etc. to develop high level of medical knowledge within sales force

REQUIREMENTS / QUALIFICATIONS:
  • MD with county licensure or fellowship required; BS in life or health sciences
  • 2 or more years of relevant experience in clinical science, medical affairs, and/or drug development
  • Advanced communication and collaboration competency, as well as advanced skills in strategic thinking and planning, medical and scientific knowledge and external stakeholder engagement.
  • Effective presentation skills with ability to distill complex issues and topics into simple terms to drive dissemination up and down the organization and with external parties
  • Must show interest in the needs, expectations and circumstances of external partners and internal stakeholders to deepen relationships
  • Ability to lead the development and implementation of strategic plans that link task to strategy achievement
  • Demonstrated comprehensive knowledge of relevant therapeutic areas and disease conditions

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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