SpringWorks Therapeutics

👥 251-500💰 $275,000,000 Post-IPO Equity over 1 year agoBiotechnologyTherapeuticsBiopharma📈 Public Company
Website LinkedIn Email Twitter

SpringWorks Therapeutics is a clinical-stage biopharmaceutical company at the forefront of precision medicine, developing life-changing medicines for patients with severe rare diseases and cancer. We are actively building our portfolio of targeted oncology drugs and are currently advancing two lead product candidates into late-stage clinical trials. Our strategic approach involves partnerships with industry and academia to unlock the full potential of our portfolio and create more solutions for patients with cancer. Our tech stack supports a collaborative and data-driven approach. We utilize technologies like Google Analytics, Google Tag Manager, and WordPress for our website presence, ensuring we have the tools for effective communication, data collection, and content management. Our engineering culture fosters collaboration and innovation to tackle complex challenges. We encourage cross-functional team work and expect our teams to contribute to the evolution of the company. We prioritize a culture that fosters growth, ownership, and community. SpringWorks Therapeutics is a rapidly growing company with between 251 and 500 employees. We offer a supportive, remote-friendly work environment, allowing our employees to work from home within the United States. As a public company listed on NASDAQ (SWTX), we have multiple funding rounds, and we are excited about our continued growth trajectory. Our commitment to DE&I and providing best-in-class benefits demonstrates our commitment to our SpringWorkers.

Related companies:

Jobs at this company:

Apply

📍 United States

🧭 Full-Time

💸 167375.0 - 220000.0 USD per year

🔍 Biopharmaceutical

  • Bachelor’s Degree in life sciences or related science degree; Advanced degree preferred.
  • 9+ years of related experience within regulatory affairs with a bachelor’s degree; or 7+ years of related experience within regulatory affairs with a master’s degree; or a PhD with 4+ years’ of related experience within regulatory affairs with; or equivalent experience
  • Oncology, rare disease, and/or other relevant therapeutic area experience is desirable.
  • Experience representing Regulatory Affairs Labeling on cross functional teams
  • Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others
  • Experience in interpreting regulations, guidelines, and policy statements relevant to labeling
  • Comprehensive knowledge of labeling regulations in the U.S. and Europe
  • Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
  • Create and maintain labeling content for marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork
  • Liaise with external partners or distributors in international markets, as applicable
  • Conduct research on competitor and other relevant labeling precedents to support high quality, commercially viable labels
  • Develop project timelines and manage labeling projects from initiation to completion
  • Lead Core Label Working group meetings and provide strategic regulatory guidance, as appropriate
  • Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork)
  • Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling
  • Help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and external partners
  • Perform other duties and responsibilities as assigned

LeadershipProject ManagementCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationWritten communicationComplianceInterpersonal skillsTeam managementStrategic thinkingData management

Posted 4 months ago
Apply