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Patient Reported Outcomes Project Leader (m/f) in Berlin

Berlin | Bundesland Berlin | Marketing Stellenangebote | Karrierestarter

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Jobbeschreibung

Your tasks and responsibilities
  • Lead the development and execution of a global, comprehensive and scientifically rigorous Patient Reported Outcomes (PRO) strategy incl. gap identification that is aligned with the clinical, regulatory, commercial and market access strategies for development assets
  • Design and lead the generation of PRO evidence (qualitative/quantitative methods) in line with the international scientific standards and Health Authority regulations, in the context of PRO tool development and validation to achieve "fitness for use" to inform the endpoint model of pivotal clinical trials
  • Coordinate a common global strategy and compile PRO evidence package for submissions to Health Authorities and Health Technology Assessment (HTA) agencies in securing marketing authorization, label enhancement and/or reimbursement as well as prepare, participate and post proceeding of interactions with these authorities
  • Collaborate with Clinical Operations on licensing/translation/linguistic validation and ePRO transfer of PRO and for approval of final language versions
  • Manage study design and execution of contracted research projects (budget negotiations, quality assurance of work conducted by vendors) and provide technical expertise in analysis and dissemination of clinical outcome assessment data
  • Represent the PRO expert function and manage effective communications with various internal global/regional team(s), as well as appropriate external forums and meetings
  • Maintain awareness, education on and implementation of new methods, tools and data sources to ensure study methods represent current state of science, as well as assessment and interpretation of relevant literature, scientific disseminations in line with internal communication
Who you are

WHO YOU ARE

 

  • Doctoral degree (PhD, DRPH, ScD) in psychometric research, health pharmacoeconomics or in a clinical discipline (medicine, pharmacy) with PRO orientation preferred or master’s degree (MSc, MPH) in health services research, public health or health/pharmacoeconomics along with several years of professional experience in the PRO area
  • Several years of experience in a pharmaceutical company and/or related consultancy company
  • Technical competency in the use of ePRO/e-clinical outcome assessment and linguistic validation of clinical outcome assessments as well as in psychometrics or statistics
  • Expert knowledge in scientific writing of psychometric analysis plans, study concepts, protocols, reports and regulatory documentation
  • In-depth knowledge of global health care systems and of clinical research, especially clinical drug studies and drug development strategies
  • Excellent process and project management skills
  • Very good interpersonal and communication skills along with ability to understand and respond to multiple internal and external customer demands as well as competency to manage and handle conflict constructively with limited supervisory support
  • Cross-functional team leadership experience desirable
  • Excellent oral and written English communication skills
Your application
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.

Mehr Informationen

Standort
Berlin
Jobart
Karrierestarter
Veröffentlicht am
14-08-2018
Tätigkeitsbereich
Marketing / Kommunikation / PR / Werbung
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