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Medical Affairs Operations Specialist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Jun 7, 2023

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Discipline
Health Sciences, Medicine
Organization Type
Pharma

Job Details

Primary Duties

The Medical Affairs & Patient Engagement Operations Specialist has the following three key areas of responsibility (not all-inclusive):

  1. Manage all Medical Affairs & Patient Engagement vendor selection and contracting acting as primary liaison with Procurement, Legal and external contacts. This is accomplished by partnering with Procurement and MA&PE subject matter experts in identifying and qualifying suitable vendors; managing contractor/consultant and vendor contract execution; processing and tracking invoicing and payments; and performing quarterly accrual tracking.
  2. Serve as MA&PE Fair Market Value (FMV) Business Owner for activities requiring HCP consultants at all HCP congresses, Advisory Boards, Scientific Education Programs (SEPs), and any relevant Patient Advocacy Group activities.
  • Responsible for calculating FMV for the engagement of HCPs in fee-for-service arrangements or engagement of vendors and other professionals in healthcare-related activities
  • Consults with Corporate Compliance and provides FMV rates to internal stakeholders related to HCP engagements
  • Facilitates background screening of HCP consultants by Compliance
  • Maintain documentation in a central department repository
  • Serve as International Coordinator in (1) the Roche iHCP portal for Development & Product Strategy to request and obtain approval for ex-US interactions involving transfer of value with HCPs when Spark engages HCPs practicing in countries outside the US (OUS); and (2) the Roche OUS Grants, Sponsorships, and Donations (GSD) portal
    • Responsible for entering engagement details in iHCP portal on behalf of the event engagement owner (EEO)
    • Review local affiliate guidance to ensure activities are compliantly executed in accordance with all laws, regulations, and policies
    • Calculate FMV for HCPs participating OUS
    • Coordinate engagement reviews with local affiliates
    • Enter all required close-out documentation, including transfers of value on behalf of the EEO
    • Maintain documentation in a central department repository
    • Partner with Compliance and the Medical Affairs Meetings Specialist to appropriately capture GSD in the Roche ex-US portal.
    The incumbent must be flexible, a team player, and an independent decision maker and problem solver capable of working in a fast-paced environment.

    Responsibilities

    Manage all Medical Affairs & Patient Engagement contracting

    Serve as Medical Affairs & Patient Engagement FMV Business Owner

    Serve as International Coordinator in the Roche iHCP portal for Development & Product Strategy

    Education and Experience Requirements

    Associate’s or Bachelor’s Degree

    5 years’ experience in biopharma industry (or relevant practice setting) providing contracting, finance operations, and/or administrative support

    Key Skills, Abilities, and Competencies

    • Ability to coordinate projects from initiation through design and delivery with minimal oversight
    • Self-starter – identifies areas for process improvement and implements
    • Proficient in Microsoft Office applications required
    • Ability to perform multiple tasks in a fast-paced, team environment
    • Solid verbal and written communication skills
    • Excellent organizational skills: ability to organize and maintain accurate, orderly files and records
    • Excellent attention to detail; ability to accurately proofread documents
    • Ability to maintain confidentiality
    • Knowledge of proper English usage, grammar, vocabulary, spelling

    Complexity and Problem Solving

    • Works on projects that may be complex in nature and confidential where judgment, initiative, and discretion are required in resolving problems and making routine recommendations (contracting, FMV, iHCP).
    • When unable to resolve problems reaches out appropriately to Medical Affairs and Patient Engagement personnel, Operations Leader, Compliance, and/or Legal as appropriate.
    • Has the ability to make independent and advise on FMV.
    #LI-hybrid

    Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

    Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.


    Nearest Major Market: Philadelphia



    Join the Spark Team

    We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

    We don't follow footsteps. We create the path.

    Learn more about Spark Therapeutics and view other openings.

    Company

    At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

    Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

    Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

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