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Medical Communications Lead-Scientific Content & Training

Date: Apr 19, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

 

Summary

 

The Medical Communications Lead-Scientific Content & Training reports into the Head of Medical Communications, Global Medical Affairs.  The Medical Communications Lead-Scientific Content & Training is an integral member of the Medical Communications team and has responsibility over the development of high-quality scientific content and educational resources to support the educational and scientific training needs of Medical Affairs, including Medical Science Liaisons (MSLs), Therapeutic Area Leads (TA), and Clinical Development personnel.

The individual will collaborate/align cross-functionally with stakeholders in Research & Discovery, Clinical Development, and Medical Affairs, as well as liaise with external therapeutic area and gene therapy experts to build Medical Affairs scientific content across therapeutic areas.

The Medical Communications Lead-Scientific Content & Training is also responsible for leading needs analysis and gap assessments to design a scientific training curriculum and content for internal training, as well as for external HCP education, inclusive of reactive and proactive slide decks, QAs, and other scientific resources.

 

  • Strategize and develop high-quality scientific content related to Spark’s investigational gene therapy, as well as TA specific disease state training materials inclusive of reactive/proactive slide decks, QAs, e-learning modules to support the educational and scientific training needs of Medical Affairs, including MSLs, TA leads and on-boarding Medical Affairs colleagues
  • Design an effective course curriculum that meets the scientific training needs of Spark Medical Affairs and identify and develop new scientific resources in support of those needs
  • Collaborate with Heads of Field Medical and Medical Communications to proactively build strategies to address and develop HCP educational resources, in alignment with asset specific strategic imperatives
  • Develop scientific slide decks related to Sparks investigational gene therapy and related content for external HCP education delivered via Field Medical Affairs Scientific Education Programs (SEPs
  • Conduct baseline and periodic evaluation of current MSL/Medical Affairs resources utilizing gap analysis and other evaluation tools, and proactively identify needs for new scientific content/update existing content
  • Develop a proactive tactical plan for the management of MSL/Medical Affairs resources
  • Identify and engage external experts as needed as consultants for scientific content development
  • Develop product and disease state expertise and keep abreast of the changing drug development environment, as well as provide support as a content expert on the development of pipeline resources
  • Collaborate with the TA Medical Communications Leads and Publications Lead to ensure strategic alignment with asset specific integrated Medical Communication and Publications Plans, including  alignment with the Scientific Communication Platform 
  • Manage the Medical/Legal/Regulatory/Compliance review and approval process for all scientific content to ensure alignment among stakeholders and compliance with Spark SOPs
  • Ensure that all developed materials are reviewed and appropriately signed off according to Spark Policies and SOPs and maintain archive of approved materials within the appropriate management system
  • Manages external Medical Communications vendors for the development of scientific content, sets expectations for timely delivery of materials and manages budgets
  • Collaborate with the Head of Medical Communications and contribute to the development of the strategic vision for the Medical Communications function and core capabilities in support of adding value to the organization
  • Assess resourcing needs for the function and present recommendations to expand/build the scientific content team
  • As needed, contribute to other ongoing projects within the Medical Communications group, including development of congress materials and congress planning
  • Contribute to preparation of SOWs and agreements with Medical Communications vendors
  • Maintain and update trackers of Medical Communications deliverables across therapeutic areas
  • Education and Experience Requirements

  • Advanced degree (MD/PhD/PharmD) with a generally 10 years of experience in pharmaceutical medical communications / publications, or at a medical communications agency in a medical director role
  • Extensive experience creating scientific content, including disease state and investigational/approved product-related slide presentations, is required.
  • Track record of exhibiting leadership behaviors related to collaborating cross-functionally to build consensus, and executing simultaneous projects in a timely manner, is required
  • Knowledge of FDA regulations regarding the dissemination of scientific content is required
  • Experience in rare disease and/or gene therapy, is preferred.
  • Management or commensurate experience such as team leadership is preferred to enable future growth of this capability
  • Experience within the pharmaceutical industry is preferred, communications agency experience will be considered
  • Occasional travel may be required (<10%)

Key Skills, Abilities, and Competencies

  • Proficiency with Veeva Vault strongly desired
  • Excellent interpersonal skills and ability to build effective partnerships and work collaboratively with internal/external stakeholders in various functions, at various levels of seniority, and with a diversity of working styles
  • Demonstrates advanced core competence in leadership and communication
  • Experience with managing budgets including review of annual budget, tracking monthly projections, and accruals
  • Develops and implements new processes, SOPs and policies to facilitate Scientific and Professional Training, including identified areas for improvement and recommended changes as needed.
  • Experience teaming with congress planning and activities around external scientific presentations
  • Excellent written and oral communication skills and the ability to take complex information and ideas and presentation in a clear and concise way
  • Demonstrated understanding of the drug development process from drug discovery to preclinical development to clinical development to regulatory approval, strong scientific acumen and experience with compilation, presentation and review of scientific data
  • Excellent time management and organizational skills; able to prioritize tasks and work simultaneously on multiple projects
  • Strong knowledge of current good publication practices and guidelines and medical writing guidelines (e.g., GPP3, ICMJE, CONSORT)
  • Experience managing external agencies preferred
  • Proficiency with computer programs such as MS Word, Excel, and PowerPoint,
  • Commitment to quality and continuous improvement

 

Complexity and Problem Solving

  • Ability to work effectively, collaboratively and independently in a fast-paced, small-team environment that is growing and evolving. This position requires regular reprioritization of projects while adhering to timelines and achievement of deliverables.
  • Ability to navigate the medical-legal review process and resolve comments appropriately and compliantly, while building working and trustful relationships with key stakeholders
  • Problem solving, negotiation and interpersonal skills, ability to work across diverse groups and senior leaders and with external key opinion leaders and researchers
  • Ability to innovate and present cutting-edge/creative solutions in the context of delivering scientific content and maintaining a high profile for the Medical Communications and Medical Affairs function by delivering exceptional value
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  • Ability to critically evaluate scientific literature and evolving competitive landscape
  • High degree of emotional intelligence and experience with working in a matrix environment and with cross-functional teams
  • Superior project management skills, ability to track progress and adjust timelines as needed
  • Ability to multi-task numerous projects at one time, prioritize projects based on Spark goals and objectives


Nearest Major Market: Philadelphia