Job Summary:

• Draft and approve study-specific medical monitoring plans
• Assume role as the main point of contact for protocol-specific medical queries including subject eligibility, evaluation and reporting of adverse events with follow-up
• Study data review on an ongoing basis
• Collaborate with the internal pharmacovigilance team to process serious adverse events
• Contribute medical input into the design of clinical development programs, study protocols, research papers, client-focused white papers etc.
• Provision of therapeutic and protocol-specific training to the project teams. 
• Supporting Business Development by participation in proposal generation, feasibility assessments, review of proposals for medical services and attending sponsor meetings
• Collaboration with Medical Writing teams and sponsors in reviewing and/or assisting in the preparation of final study reports or other study documentation. 
• Develop and execute global medical strategy for assigned brands
• Partner with Commercial & Marketing teams on brand strategy and planning

Skills on Resume: 

• Medical Monitoring (Hard Skills)
• Adverse Event Reporting (Hard Skills)
• Data Review (Hard Skills)
• Pharmacovigilance Collaboration (Hard Skills)
• Protocol Design (Hard Skills)
• Therapeutic Training (Hard Skills)
• Business Development (Soft Skills)
• Strategy Planning (Soft Skills)

Job Summary:

• Implementing and executing the global medical affairs strategy for insomnia and driving activities that will lead to successful launches
• Build and develop peer-to-peer relationships with the relevant Key Opinion Leaders while collaborating with Global Clinical Development on interactions with investigators participating in clinical trials, investigator meetings and advisory boards
• Manage innovative insomnia-related real-world evidence (RWE) generation programs & investigator-sponsored studies with centers of excellence
• Closely collaborate with Global Clinical Development to provide input in the design of Phase IIIb and IV trials
• Develop and implement a novel scientific communication plan and contribute to the medical/scientific review of manuscripts
• Accountable for the medical/scientific review of scientific communication platforms, medical information resources, medical education materials & marketing materials
• Develop product-specific training for Medical teams in the countries to deepen the product and scientific knowledge within insomnia and create informative medical decks for external use
• Communicate in a compelling manner the medical value of the asset, inside and outside the company, such that it generates excitement and enthusiasm
• Ensure on all levels cross-functional collaboration with Marketing, Regulatory, Drug Safety, Market Access, and Research & Development
• Enable access to medicines through a clear understanding and education of treatment value in partnership with cross-functional team members

Skills on Resume: 

• Global Strategy (Hard Skills)
• Peer Relationships (Soft Skills)
• Real-World Evidence (Hard Skills)
• Trial Design (Hard Skills)
• Scientific Communication (Hard Skills)
• Medical Review (Hard Skills)
• Product Training (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)

Job Summary:

• Lead the Otezla Global Medical Affairs Team
• Serve as Global Medical Affairs lead on Product Team
• Serve as a core member of the Evidence Generation Team
• Lead the RWE team, ensuring the RWE Evidence Generation Plan addresses key regional/local needs
• Gather clinical insights across all key markets and translate them into practical strategies
• Develop medical strategic plans, ensuring alignment throughout Medical Affairs Teams/Functions
• Establish and oversee the implementation of the medical communications strategy and related activities, e.g., product narrative, scientific platform, core content, publications, medical education, and congresses
• Facilitate scientific engagement across a broad range of collaborators in order to strengthen external understanding of the unmet need and medical value.
• Contribute to Amgen's Safety and Benefit/Risk profile of a molecule and ensure communication of the implications to external partners, support investigator-sponsored studies (ISS), and approve competitive grants, if applicable
• Provide strategic direction for study design and execution for medical affairs studies

Skills on Resume: 

• Team Leadership (Soft Skills)
• Medical Strategy (Hard Skills)
• Evidence Generation (Hard Skills)
• Clinical Insights (Hard Skills)
• Medical Communication (Hard Skills)
• Scientific Engagement (Soft Skills)
• Benefit/Risk Communication (Hard Skills)
• Study Design (Hard Skills)

Job Summary:

• Lead development and maintenance of scientific strategies for Established Products in Santen’s portfolio
• Conduct data analyses, identifying data gaps in Santen data and in the literature and formulate plans to fill data gaps
• Work with the publication lead to develop the publication and congress strategy for Established products
• Conduct cross-functional data summits to further Santen’s understanding of clinical data and data in the literature
• Manage repositories of available Santen data, making data and study-related information accessible to the Global Medical Affairs team
• Design appropriate post-marketing studies for Established products
• Understand the level of scientific expertise across multiple departments and proactively provide audience-appropriate internal scientific education
• Facilitate advisory boards, identifying needs for external input, selecting appropriate advisors, and ensuring external input reaches all appropriate Santen stakeholders
• Support dossier development with scientific, editorial or other support.
• Participate in regulatory filing teams

Skills on Resume: 

• Scientific Strategy (Hard Skills)
• Data Analysis (Hard Skills)
• Publication Strategy (Hard Skills)
• Data Summits (Soft Skills)
• Data Management (Hard Skills)
• Post-Marketing Studies (Hard Skills)
• Scientific Education (Soft Skills)
• Advisory Boards (Soft Skills)

Job Summary:

• Serve as a scientific subject matter expert on external podium presentations
• Establish and maintain strong peer-to-peer relationships with key medical thought leaders in the fields where Santen offers Established products
• Liaise closely with Data Sciences and Clinical Operations departments to ensure Global Medical Affairs has access to current and accurate data and clinical trails
• Provide rigorous scientific review of medical and promotional materials as well as of Grant requests such as Independent Medical Education and investigator-initiated studies
• Generate audience-appropriate scientific and medical insights to cross-functional teams at various levels within the Santen organization
• Work in close partnership with the Field Medical Team to collect valuable Field Insights and apply to the medical strategy
• Contribute Medical knowledge and expertise to Training activities targeted at internal and external audiences (e.g., Commercial teams and Speakers, respectively)
• Devise an external engagement strategy and maintain relationships with top-tier KOLs
• Ensure materials and educational activities are compliant and of the highest scientific quality

Skills on Resume: 

• Scientific Expertise (Hard Skills)
• Peer Relationships (Soft Skills)
• Data Liaison (Hard Skills)
• Scientific Review (Hard Skills)
• Medical Insights (Hard Skills)
• Field Insights (Soft Skills)
• Training Contribution (Hard Skills)
• External Engagement (Soft Skills)

Job Summary:

• Develop and deliver the Brand Medical Plan(s) aligned to the TA Medical Strategy
• Leveraging relationships with external customers to ensure robust physician and patient’s insights is what drives successful product launches
• Interfacing with internal and external stakeholders in conjunction with the local medical teams to enhance the scientific and clinical understanding of drugs in the therapeutic area
• Managing and developing both existing and new medical activities supporting the delivery of commercial success, along with high ethical standards and full compliance with ethics and regulatory requirements. 
• Interact with external stakeholders in alignment with customer needs and medical strategy
• Maintain the Knowledge Base and Competitive Intelligence
• Maintaining company standards
• Provide scientific leadership and expertise to other business functions 
• Develop data generation and real-world evidence plans
• Oversee ongoing and proposed IITs

Skills on Resume: 

• Brand Medical (Hard Skills)
• Customer Relationships (Soft Skills)
• Stakeholder Interface (Soft Skills)
• Medical Activities (Hard Skills)
• External Alignment (Soft Skills)
• Competitive Intelligence (Hard Skills)
• Scientific Leadership (Soft Skills)
• Data Generation (Hard Skills)