May 19, 2021
Oyster Point Pharma
Princeton, New Jersey
Oyster Point Pharma, Inc. (OYST: Nasdaq) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Headquartered in Princeton, New Jersey, with an anticipated satellite office in Boston, Massachusetts, Oyster Point filed its first New Drug Application in Q4’ 2020 with an anticipated product launch in Q4’ 2021. This is an exciting time to join Oyster Point as it prepares to transition from a clinical stage company to a commercial enterprise.
Develop medical Information standard response documents (primary responsibility)
Serve as focal point of medical information vendor/ call center and other medical affairs processes.
Develop, review, and provide medical responses to triage escalated questions incoming from medical information vendor/call center.
Self-maintains an in-depth understanding of the medical strategy and broader therapeutic area strategy to ensure activities are coordinated and aligned.
Works to the highest ethical compliance, ethics, and safety standards
Creation and optimized implementation of processes related to medical information/call center operations, field operations, insight gathering and processing, and external medical communications.
Ensure all interactions and activities adhere to compliance guidance in all activities, including those related to scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
Ensure Eye Care Provider needs/issues with Oyster Point products are resolved with the ultimate goal of ensuring patients receive the best care.
Evaluate and work with external medical information partner/call center to improve workflow and quality-related processes, methods, and policies by developing key performance indicators (KPIs)
Identify, on a continuous basis, areas of improvement for call center operations (e.g., compliance, efficiency, quality) and work closely with internal stakeholders and external vendor partner to prepare solutions.
Participate in training of call center partner staff.
Manage vendor partner budget.
Lead medical affairs insight gathering process in order to collate intelligence gathered through Oyster Point Medical Directors and call center and provide insights to internal stakeholders on unmet needs/data gaps and work collaboratively towards innovative solutions.
Review promotional and educational materials for scientific accuracy on Medical Legal Regulatory Committee (primary responsibility)
Serve as medical expert on product and disease state on Medical Legal Regulatory Committee
Assist publications with coordination of Publications review and approval process, integration of reviewer comments of assigned external-facing publications and scientific presentations.
Develop and maintain, in a self-driven manner, outstanding knowledge of competitor products, and other therapeutic options within therapeutic area.
Collaborate with cross functional team to ensure the best patient care.
Contribute to the development of core scientific content (disease state and product-specific)
Understand US regulatory landscape and apply expertise to development of scientific resources.
Drive and/or support strategy and scientific content development for scientific meetings, including execution of congress deliverables, disease state education programs, and developing/adapting scientific content for digital platforms.
BSc, preferably master´s degree in Life Science.
3-5 years’ experience managing global cross-functional project management, incl. process improvement / change projects in a pharmaceutical or biotech company is required.
Working knowledge of standard Project Management tools (MS Project, Excel, Visio, SharePoint)
PMP or Project Management certification is desirable.
MD, OD, PhD, or PharmD (Ophthalmology-focused background strongly preferred)
Ophthalmic clinical background or previous similar ophthalmic industry Medical Affairs experience preferred.
Project management capabilities and deadline focused expertise
Analytical capabilities (data analysis, statistical concepts).
Demonstrated knowledge and understanding of pharmaceutical development and commercialization process.
Excellent verbal & written communication skills
Strong leadership and team building
Ability to work and collaborate with all levels and groups and lead without authority.