Medical Affairs Operations Specialist

Primary Duties

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

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.

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.