Partner Companies

Bayer HealthCare

Bayer HealthCare Website
100 Bayer Blvd, Whippany, NJ 07981

Fellowship Duration

2 years

Fellowship Positions Available

Bayer HealthCare Pharmaceuticals

Business Development and Licensing

Clinical Operations

Corporate and Government Customers/US Managed Markets

Early Pipeline Strategic Marketing

Global Market Access/Health Economics and Outcomes Research

Global Regulatory Affairs

Medical Communications

Global Medical Affairs - Oncology

Bayer HealthCare Consumer Care

Global Pharmacovigilance and Product Quality & Safety

Global Medical Affairs and Clinical Development

Global Product Development and Innovation

Innovation, Research and Development Category Leadership

Rx-to-OTC Switch

US Regulatory Affairs

Company Information

Pharma

Medical Communications

  • Provide balanced, written, and verbal scientific responses to inquiries from consumers and health care professionals in a compliant manner
  • Identify, document, and process adverse events and product complaints
  • Research medical literature and evaluate scientific data to develop evidence based medical content for responses
  • Review advertising and promotional materials to ensure medical accuracy
  • Collaborate with cross-functional team members to ensure advertising and promotional materials meet legal, medical, regulatory and commercial objectives
  • Provide medical information booth support at medical conferences
  • Develop medical educational materials and present lectures to sales training groups and other company employees

Medical Science Liaison | Oncology

  • The Fellow will work with the US Medical Affairs Oncology Department during their tenure in the Fellowship Program
  • Engage in the exchange of data and knowledge in a scientific and balanced manner as they relate to clinical research, disease state awareness, pipeline assets, and therapeutic trends
  • Gain an understanding of thought leader (TL) engagement, mapping, and territory management by developing and fostering relationships with critical stakeholders, TLs, Health Care Professionals (HCPs) and institutions
  • Attend and actively participate in relevant scientific and professional meetings, including major medical meetings and Bayer Advisory Boards
  • Participate in the review process and discussion strategy for Investigator Initiated Research (IIR) as well as Company Sponsored Studies (CSS).
  • Evaluate funding requests for Continuing Medical Education and Grants (as needed).

Brand Marketing, U.S. Managed Markets 

  • Gain hands-on experience within Corporate & Government Customers (CGC), Bayer HealthCare’s U.S. Managed Markets Department
  • Serve as US Managed Markets Brand Managers, rotating through Bayer’s therapeutic areas (i.e. Women’s Healthcare, Oncology, Neurology, and Rare Diseases) directly supporting Managed Markets Brand Directors
  • Gain a deeper understanding of all managed markets segments and customers (i.e. health plans/PBMs, specialty pharmacy, trade, integrated delivery networks, group purchasing organization, and government) 
  • Provide patients with access to Bayer’s product portfolio by collaborating with in-house and field-based managed markets colleagues, cross-functional teams, key customers, and market access agencies to drive forward business and serve customers by:
  • Supporting creation of product value propositions to managed markets customers by working with market research, health economics and outcomes research, medical affairs, and the business unit
  • Developing promotional materials for our products and training field-based account executives on appropriate use of pieces
  • Managing strategic relationships and projects with agency partners
  • Supporting review of marketing materials through the promotional review process with legal, medical, and regulatory colleagues

Global Regulatory Affairs

  • Provide regulatory expertise and guidance in all aspects of the drug development process to ensure the production of quality submissions during pre and post-marketing phases
  • Ensure compliance with Corporate and Regulatory standards allowing for expeditious review and approvals
  • Maintain marketed products including all promotional activities in compliance with regulatory requirements
  • Understand and apply the principles of regulatory affairs
  • Gain working knowledge of regulations, guidelines and standard practices
  • Develop the operational proficiency of effective regulatory professional
  • Areas of Opportunity: Global Regulatory Strategy (US & International), US Advertising and Promotion, Global Labeling, Regulatory Intelligence & Analytics, Global CMC management (drugs & biologics), Submission Planning and Management, Consumer Health Regulatory Affairs

Clinical Operations

  • Understand the management of phase I clinical trials from study concept to clinical study report.
  • Support and lead the study team by managing all activities as defined per SOPs/OI and ensure regular study team meetings
  • Understand budgeting, payments, accruals, and forecasting
  • Ensure all relevant IT-systems are updated with current and accurate information
  • Train and oversee CROs/vendors: kickoff meetings, study start-up, conduct, and closeout
  • Interact with all members of the clinical development team (regulatory affairs, statistics, data management, medical writing, drug supply, etc)
  • Develop protocol/amendment in collaboration with other study team members
  • Gather and assess patient data review and safety reports

Global Pharmacovigilance and Product and Quality Safety (Pharma)

  • Critically evaluate and communicate scientific information regarding Bayer and competitor products
  • Prepare safety assessments for new and existing products including pharmaceuticals, medical devices and combination products
  • Work in a global safety environment applying skills and knowledge across different geographies and cultures
  • Collaborate with colleagues in a multi-disciplinary setting to conduct benefit:risk assessments and risk minimization plans for existing and new products. These disciplines include medical affairs, clinical development, regulatory affairs and etc. Rotations in other functional areas can be arranged
  • Draft scientific and regulatory documents including Common Technical Documents, Periodic Benefit-Risk Evaluation Reports, and labeling justification documents

New Product Commercialization

  • Contribute to the execution of commercial activities in the US commercialization/launch readiness plans to ensure cross-functional alignment and achieve launch preparedness and excellence
    • Participate in new product teams to help establish commercialization plans for later stage assets
    • Support brand planning/launch planning process and collaborate with cross-functional teams (including Medical Affairs, Regulatory, Corporate & Government Customers, Global)
  • Compile competitive intelligence and provide data analyses/reports
  • Engage in market research activities
  • Assist in preparing US commercial assumptions and recommendations into US business cases

Consumer

Global Medical Affairs & Clinical Development

  • Propel the Consumer Health business through medical and product insights and innovations in clinical research
  • Develop new claims, indications, and dosage forms for OTC products
  • Design, conduct, and support clinical research activities using vigorous scientific methodologies and Good Clinical Practice (GCP)
  • Maintain scientific and clinical expertise to support currently marketed products, participate in the review of advertising and promotional material, and provide medical support to marketing initiatives
  • Collect, review, assess, and disseminate scientific and clinical information as it relates to the company products or competitive products
  • Interact regularly with all members of the global and/or US clinical development teams, as well as other functions, particularly Regulatory Affairs and Project Management
  • Provide support for the strategy, coordination, and implementation of advisory board meetings and FDA advisory committee meetings
  • Collaborate with key opinion leaders

Global Product Development & Innovation

  • Develop innovative OTC/nutritional supplement products for Bayer Consumer Health
  • Design and implement pre-formulation, formulation, process, project timelines and basic analytical activities for new products using Quality by Design principles
  • Perform experiments in the laboratory to formulate and test prototypes, develop a manufacturing process, and scale-up the product
  • Actively engage in literature and patent searches related to products
  • Participate in consumer insights based new product ideation and product design sessions
  • Help design and refine prototypes with the consideration of product stability, regulatory and medical acceptability
  • Interact regularly with all members of the Global Innovation and Development Teams and cross-functional members of the Core Team
  • Assist with managing the product development process from concept phase to the post-launch analysis phase
  • Write development plans, reports, and CMC technical regulatory documents for projects and share scientific work with other functions
  • Author and review chemistry, manufacturing, and controls (CMC) sections (Module 3) of Global Dossiers, variations of currently registered products, and quality overall summaries of dossiers
  • Interact with manufacturing sites, Global and Local Regulatory colleagues to gain alignment on CMC documentation

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