Inserat online seit: 10 Juni
Aufgaben der Stelle
PpAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is nolonger a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives ofthose around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you'rehungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. /p h3Senior HEOR Manager Patient-Reported Outcome (12 months contract) m/f/d /h3 pAs a Senior HEOR Manager COAs/PROs, you are at the forefront of clinical outcome assessment (COA) activities and projects across various therapeutic areas within our organization, always prioritizing a 'patient-first' mindset. Your role is pivotal in COA strategic planning and execution, ensuring high impact and scientific integrity. You will collaborate and lead internal cross-functional teams and external vendors to successfully implement COA initiatives, including patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), and other COA assessments for clinical programs. Your mission is to enhance the patient experience from trial design to final reporting, ensuring commercial and regulatory success of products that include COAs in their endpoint measurement strategy across clinical lifecycles. /p pbYOUR TASKS AND RESPONSIBILITIES: /b /p ul liLead the development and execution of strategic COA plans for products across therapeutic areas, owning the COA Strategy Document for each program; /li liGuide internal teams in selecting appropriate COAs for clinical trials and provide input into clinical documents throughout the trial lifecycle; /li liLead the scientific execution of COA projects with external vendors and internal stakeholders; /li liProvide guidance to project teams, ensuring adherence to COA regulatory requirements and best practices; /li liOversee COA validation and interpretation, ensuring psychometric evidence meets regulatory and HTA criteria; /li liCollaborate on COA data analysis and reporting, preparing regulatory or scientific documents as needed; /li liPrepare COA-related regulatory and scientific submissions, leading relevant sections for regulatory agencies; /li liStay current with COA-related scientific organizations and methodologies, incorporating advances into programs. /li /ul pbWHO YOU ARE: /b /p ul liAt least a master's degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related field. A Ph.D. is preferred; /li li5+ years of applied experience in health outcomes research, with demonstrated leadership and expertise in COA/PRO methodology and regulatory requirements; /li liStrong ability to analyze and validate COA data, apply COA validation methodologies, and derive regulatory-ready insights; /li liAbility to develop strategies and implement tactics for optimal clinical outcome strategy addressing market access or regulatory needs globally; /li liExcellent leadership skills with experience leading cross-functional teams and managing external vendors; /li liUnderstanding of electronic COA migrations and latest eCOA implementation standards; /li liProven ability to interact effectively with internal and external stakeholders, navigating competing priorities; /li liHigh degree of empathy and inclusive mindset to work with diverse external stakeholder groups. /li /ul pWe are looking forward to receiving your application by 15th June. Thank you! /p /p #J-18808-Ljbffr