Execute the strategic FMA training plan supporting the therapeutic area Business Unit and new product launch initiatives.
Develop and refine the GMA new hire FMA learning curriculum for their therapeutic area (i.e., Nephrology/Immunology).
Lead virtual classrooms, competency assessments & certifications (live and virtual) and serve as a key presenter and co-author of the Peak Performers series.
Otsuka is a global healthcare company committed to developing and commercializing innovative products in neuroscience, nephrology, and digital medicine. The company employs 34,400 people worldwide, including 2,200 in the U.S., and is dedicated to defying limitations for patients and earning recognition as a Great Place to Work.
Lead strategic planning and execution of Medical Affairs initiatives aligned with corporate objectives.
Drive operational excellence through process improvement, change management, and performance tracking.
Partner with cross-functional stakeholders to ensure seamless integration of medical strategies.
Kardigan is a heart health company working to make cardiovascular disease preventable and curable. They're driven by patients and their families, deeply committed to improving lives and prioritizing patient needs, authentic, always learning, winning as a team, and enabling the impossible.
Own the end-to-end promotional medical education function.
Establish an integrated promotional education roadmap aligned to company objectives and customer needs.
Deliver high-quality educational experiences through live, virtual, and hybrid formats.
Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. They are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of their investigational COMP360 synthetic psilocybin treatment.
Focuses on training sales professionals operating in Immunology
Develops and manages training programs that support the promotion of a product
Assesses capability and training needs for customer-facing teams
Keenova pairs quality therapeutics with human support to help patients find comfort and confidence. They bring expertise to therapeutic areas including immunology, urology, and men’s health. Keenova's dynamic work environment provides unique experiences for employees to grow and develop.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
Provide leadership for overall Medical Affairs and Clinical Affairs teams.
Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required.
Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory bodies.
Waters Corporation is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. Through a shared culture of relentless innovation, their passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Serves as a dedicated strategic partner to assigned operational or functional business areas.
Translates business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions.
Accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness.
Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They employ scientists, business professionals, and researchers united around a common goal–to discover, develop, and deliver innovative medicines.
Owns the strategy, execution, and evolution of how learning happens across the organization.
Leads a fully remote national training team while remaining deeply embedded in the field.
Actively facilitates training, co-creates content with subject matter experts, pilot new programs.
They are the fastest growing garage door platform in the industry. They consistently develop leaders, technicians, sales professionals, and support teams across dozens of brands which directly drives performance, retention, and culture.
Engage with KOLs and external experts to discuss clinical data, emerging research, and disease-state insights
Support investigator-initiated and company-sponsored studies and represent the company at scientific meetings and congresses
Deliver clear, balanced scientific presentations and communicate field insights to internal stakeholders
Deciphera is committed to fair and equitable compensation practices. Deciphera believes in providing a competitive compensation and benefits package to all employees and values diversity.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.