Medical Affairs Operations Associate

Employer
Spark Therapeutics
Location
San Francisco, California
Salary
Salary not provided
Closing date
May 24, 2022

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Summary

The Medical Affairs Operations Associate supports the implementation, integration, and management of Operations strategies, programs, services and tactics or key initiatives in collaboration with other members of the medical affairs team and relevant internal stakeholders.

As part of the medical affairs team, this role will share responsibility for achieving department objectives. In delivering against assigned objectives, the role collaborates and integrates extensively with other members of the medical affairs team and multiple other internal functions. The role also requires flexibility to respond to requests from leadership to support various key projects and initiatives that may arise.

Core responsibilities align to MA Operations areas of focus: Project Management, Process Management, and Technology:
  • Overseeing the MAT process for all submitted materials including those developed by other internal stakeholders (eg, R&D, regulatory). Includes management of Veeva Vault and coordination with CAT stakeholders to ensure consistent stakeholder expectations.
  • Manage comprehensive Medical Affairs calendar of scientific congresses and internal meetings and offsite retreats
  • Accountable for the ongoing functioning of Spark’s scientific literature delivery service and subscription base
  • Serve as IME and IIR/IIT coordinator as needed by Medical Affairs Project Managers and Therapeutic Area Leaders
  • With the Medical Affairs Operations Leader, develop and maintain comprehensive new employee onboarding program for clinical-medical organization
  • Lead internal and external MA department communication initiatives using appropriate channels (eg, Spark Space)
  • Develops and maintains the medical material approval team (“MAT”) process and system knowledge (e.g., routing, approval and production). Works closely with cross-functional stakeholders to facilitate review and approval of all MAT materials, including but not necessarily limited to those generated by team members among medical affairs, regulatory, R&D, legal, corporate communications, and product development strategy. Serves as a liaison for all individuals within the approval process, routing projects through the approval process, establishing timelines, and facilitating meetings. Provides solutions and contingency plans through comprehensive review of alternatives. Utilizes the quality control process (eg, agency copy editing) per established standards (eg, corporate and scientific branding, compliance guidelines). Maintains and applies knowledge of internal guidelines (eg, corporate and scientific branding, corporate and medical affairs operations compliance)
  • Supports Operations Leader in development and implementation of new-hire onboarding process for Medical Affairs. Organizes learning documents, meets with new team members regularly to provide organizational guidance, enables access to MA systems, and develops an outstanding knowledge of MA working relationships and activities to facilitate new-employee networking
  • Owns Spark’s scientific literature service, ensuring functionality of document delivery, maintenance of subscription base, and partnership with and/or direction of a scientific librarian contractor
  • Other responsibilities reflecting steady growth of medical affairs and the company


HYBRID WORK SCHEDULE

Education and Experience Requirements

  • B.A. or B.S. required
  • Minimum 2 years of relevant working experience across:
  • Project management
  • Medical affairs, marketing or commercial operations
  • Medical communications agency


Key Skills Abilities and Competencies

  • Self-starter who functions well independently or within a team
  • Demonstrates the ability to prioritize and multitask to enhance productivity and manage workload in a fast-paced, rapidly changing environment.
  • Project management skills and process orientation
  • Demonstrates critical, creative thinking and problem-solving skills, and the ability to produce clear and concise written and verbal communications.
  • Works with a sense of urgency, efficiency, and attention to detail.


Complexity and Problem Solving

  • Internal coordination and leadership of MAT, resolving conflicts/comments as they arise
  • Management of competing priorities and resources in managing project-management systems and dashboards

#LI-JL1

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.

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.

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