The Medical Communications Therapeutic Area Specialist-Ophthalmology and Gene Therapy reports into the Global Medical Communications Leader, Global Medical Affairs. The Medical Communications Therapeutic Area Specialist is an integral member of the Medical Communications team and is responsible for developing high-impact asset specific strategic Scientific Communications for Gene therapy and Ophthalmology, including integrated Medical Communication Plan which comprises but is not limited to the Scientific Communication Platform/Scientific Narrative, asset publication plan, congress strategy with HCP-directed educational symposia, HCP medical education, and Medical Affairs scientific booths. The ideal candidate will have at least 2 years’ experience in Medical Communications, either within the pharmaceutical industry or in a Scientific Communications agency or relevant Medical Affairs experience (i.e. Medical Affairs Fellowship).
The candidate will engage with cross-functional partners including Asset Team, Research & Discovery, Clinical Development, Commercial Development, Patient Advocacy and Medical Affairs, and oversee the conceptualizing, development and evolution of asset-specific strategic scientific narrative to be incorporated consistently across multiple platforms, including publications, congresses, and internal/external scientific educational resources. This role will require the ability to interpret scientific/clinical data, an understanding of the scientific research and healthcare landscape, an ability to interact and develop professional relationships with KOLs and external faculty and will help develop and communicate a compelling Scientific Platform and narrative for identified Spark products.
This person is accountable for writing/directing the development of slides and other scientific documents containing data from company-sponsored clinical and preclinical programs with minimal supervision. Internal documents may include scientific platforms, dossiers, and presentations. The scope also includes developing and executing a strategic publication plan, and strategic insight into the congress sponsorship plan in collaboration with the Medical Affairs Therapeutic Area Specialist. He/she will work on cross-functional teams and manage external vendors and associated budgets when appropriate to support the activities mentioned above.
% of Time Job Function and Description
40% • Collaborate with R&D, Medical and Commercial partners on developing a Medical Communications plan that is supportive of strategic medical objectives.
• Develop Scientific Communications for Gene therapy and Ophthalmology, including integrated Medical Communication Plan which comprises but is not limited to the Scientific Communication Platform/Scientific Narrative,
• Develop congress strategy and execute medical education programs, scientific congress activities, and medical society outreach to educate the medical community and build advocacy for Spark development and launch activities.
40% • Lead and facilitate cross-functional publication planning meetings and serve as the point person for the development and execution of the strategic publication plans.
o Lead the appropriate review and approval of publications/projects, including abstracts, posters, oral presentations, and manuscripts from company-sponsored clinical trials, medical and/or therapeutic area congress assets for the assigned TA
o Ensure all assigned company-sponsored publications are developed according to company publication policy and good publication practice, including published guidelines (e.g., GPP3, ICMJE, CONSORT).
• Develop and maintain effective working relationships with internal and external partners and authors
20% • Plan, track, and manage budget for assigned therapeutic area’s Med Comms projects
• Develop forums and processes to communicate results and accomplishments to key stakeholders and to senior management
Education and Experience Requirements
• Advanced degree (PhD/PharmD) with minimum 2 years of experience in pharmaceutical medical communications / publications, or at a medical communications agency preferred, but relevant medical affairs experience accepted.
• 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
Key Skills, Abilities, and Competencies
• Proficiency with Veeva Vault and Pubs Hub 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
• 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 activities around external scientific presentations
• Excellent written and oral communication skills and the ability to take complex information and ideas and present it in a 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
• 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
• 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
Internal and External Contacts
• Medical Affairs Lead-Ophthalmology
• Medical Communications Lead-Scientific Content & Training
• Meeting Services Specialist, Medical Communications
• R&D Operations
• R&D leadership and other internal subject matter experts
• Development and Product Strategy
• Corporate Compliance
• Corporate Communication
• Third Party Scientific Communications Consultants and Companies
• External Scientific Conference Coordinator
Other Job Requirements
Travel: Up to 20%
• Physical Abilities: Ability to sit and stand for extended periods and utilize computer equipment.
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.
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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.