Acelrx

  • Medical Affairs Associate

    Job Locations US-CA-Redwood City
    Posted Date 3 months ago(5/30/2018 5:47 PM)
    ID
    2018-1166
    # of Openings
    1
    Category
    Medical Affairs
  • Overview

    As part of Medical Affairs team and reporting to the Executive Director, Medical Affairs, this individual would work with Medical, Commercial and Regulatory team members in planning, implementing and executing projects related to the development and management of a commercially-ready risk management program, in accordance with company SOPs, FDA and ICH guidelines and regulations.  Additionally, this role will provide support for Medical Review Committee (“MRC”) activities, including coordination of the review of medical and scientific materials intended for use in non-promotional settings with healthcare providers, presentations to Managed Care, Market Access Pharmacy and Therapeutics (P&T) Committees, and Medical Affairs training.

     

    This individual will play a pivotal role in managing timelines and deliverables for key risk management and MRC milestones for the company. He/she will need to apply project management related support to teams and team leaders to meet overall corporate objectives in building a compliant REMS program and MRC process.  This individual must work collaboratively with all levels of internal and field staff in addition to maintaining professional demeanor with outside contacts.

    Responsibilities

    • Responsible for managing overall project timelines and deliverables for assigned projects.
    • Responsible for the management of REMS database, certifications, fulfillment requirements, and reporting timelines.
    • Serves as the REMS point person for the AcelRx Contact Center, Medical Science Liaisons, Commercial field staff, Wholesalers and Authorized Representatives.
    • Manages the day to-day administration of the MRC, including reviewing MRC submissions for completeness and quality, distributing materials to the MRC for review, monitoring timeline adherence, scheduling MRC meetings, ensuring required archive and documentation occurs, and liaising with the MRC Chair and Medical Affairs as needed to ensure process effectiveness.
    • Joint responsibility for management of external vendors and drafting annual REMS report to FDA, including the compilation of data from several internal and external sources.
    • Is accountable for routine and Ad Hoc reports to the senior leadership team as to the status and, when necessary, corrective action necessary to meet project timeline and deliverable objectives.
    • Designs, implements and assesses the effectiveness of standardized project management processes and procedures. This includes standardized project tracking and reporting procedures.
    • Assists, as needed, with other responsibilities of the Medical Affairs Department, including compliant processing of Advertising and Promotional material, preparation of support materials for publications and presentations as well as serving as a resource for clinical and scientific information.

    Qualifications

    • BS or higher in a Biological/Medical discipline or comparable field of study from an accredited college or university.
    • Relevant experience in clinical or other research, medical device or drug delivery, which routinely required influencing in a multidisciplinary environment.
    • Experience working on the successful implementation of complex projects with multiple internal and external stakeholders. 
    • Excellent verbal and written communication skills with the ability to interface effectively with senior management, interdisciplinary project teams and external vendors. 
    • Experience working with cross-functional project teams is required. 
    • Superior computer skills required.  Must be experienced with word processing, spreadsheet and database applications, including MS Project and MS Office (Word, Excel, PowerPoint, Outlook), used to support medical affairs initiatives including REMS administration and management.
    • Experience with and working knowledge of the risk management, REMS and related regulatory process is a plus.

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