MDea, Inc.

  • Senior Manager, Medical Information

    Job ID 2018-1254
    Job Locations
    US-NY-New York
    Category
    Medical Information
  • Overview

    Candidate should reside on the East Coast, ideally located in the Northeast

    We are current seeking a seasoned Sr. Manager, Medical Information (MI) to support our EMEA Medical Affairs department. The successful candidate for this role will have a proven track record of developing documentation frameworks for Medical Affairs groups in varied industries, including Policy and SOP creation, drafting compliant standard response letters (SRPs), and developing a repository for relevant literature, studies and SRPs. In addition, the Medical Information Scientist will be responsible for ensuring that MI requests are answered in a timely and compliant manner,  and determining when a question or request should be escalated. To be a star in this role, you should also have the ability to create and maintain a registry of KOLs, their relevant manuscripts, studies (including ISRs), and speaking presentations, and be available for advisory board participation.

    Responsibilities

    Overall Role Competencies

    • Help map and shape a paradigm that explores potential for alternatives to cigarette smoking including mitigation and cessation.
    • Demonstrate fundamental therapeutic area and product knowledge to effectively contribute and support CLIENT’s Medical Affairs strategies and objectives.
    • Engage in scientific exchange about CLIENT’s products and ensure appropriate dissemination of clinical and scientific information.
    • Maintain clinical and technical expertise in specific therapeutic areas
    • Maintain cross-functional collaboration with internal teams: Business Planning, Patient Advocacy, Clinical, Regulatory, Legal, etc.
    • Contribute to the development and implementation of medical education strategies and initiatives, publication planning, development of medical education material, internal training, etc.
    • Perform and complete administrative responsibilities and internal projects timely, activity reports, KOL contact documentation, expense reports, etc.
    • Achieve all metrics as assigned
    • Fully comply with all laws, regulations and Client Policies, Code of Conduct, all privacy and data guidelines, relevant state and federal laws and regulations.
    • Perform special projects and assignments as directed

    Responsibilities

    • Provide complete, accurate, balanced and referenced responses to medical information inquiries from healthcare professionals and patients, both verbally and in writing
    • Create, revise and update Policies and SOPs related to Medical Affairs
    • Create, revise, update and review standard response documents
    • Research relevant meetings and congresses across the EU, Far East and Africa and prepare a strategic plan for attendance
    • Liase with the EU MSL team to advise on upcoming relevant meetings and spearhead obtaining information and planning of the conference agenda including session and poster planning
    • Staff the medical affairs booth at major scientific meetings
    • Conduct product trainings and tailoring the content to the needs of diverse audiences (e.g. Call Center personnel, field-based representatives, etc.) Provide verbal and written clinical and technical responses to internal customers
    • Create and maintain a repository for company studies, publications, white papers, slide decks and other relevant medically related materials
    • Create and maintain a KOL registry
    • Facilitate intake and triage of adverse events and product complaints as they relate to CLIENTs products
    • Conduct literature reviews and provide written summaries of the literature to the medical affairs and clinical teams
    • Assist in creating pre-and post-meeting data summaries
    • Perform other relevant tasks as requested

    Qualifications

    PERSONAL AND PROFESSIONAL QUALIFICATIONS:

    EDUCATION:  clinical or advanced doctoral degree (MD, PhD or PharmD) required

    • 5+ years biotechnology or pharmaceutical experience is required, particularly encompassing the areas of psychiatry, oncology and cardiovascular/pulmonary. Experience working in a new department  or start-up and the requisite infrastructure a must. Experience with devices a plus. 
    • A demonstrated ability to work cross-functionally
    • Excellent verbal and written communication skills
    • Proficient in MS Office and Google Suite applications
    • Thorough knowledge of drug, pharmaceutical, and/or medical devices, treatment guidelines, medical practice groups, clinical research processes, customer strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is preferred.
    • Up to 20% international travel may be required, some domestic travel may be required as well
    • Must be a strong team player and effectively interface with other internal departments
    • A valid US Driver’s License and a good driving record are required.
    • Candidate should reside on the East Coast, ideally located in the Northeast

    CLIENT PERKS & BENEFITS:

    • A place to grow your career. We’ll help you set big goals - and exceed them
    • Work with talented, committed and supportive teammates
    • Equity and performance bonuses. Every employee is a stakeholder in our success
    • Cell phone and internet subsidy, transporation benefits and discounts on CLIENT products
    • Excellent medical, dental and vision benefits

    Client is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. Client also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have the authorization to work for Client in the US.

     

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