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Manager Phase IV m/f

MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg

For Us, It’s A Mission

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in approximately 140 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 35,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a ‘doer’ and have a passion for serving others, we want to talk to you.

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.

Job Duties and Core Responsibilities

  • Support project setup, oversight and control for national and international observational studies after registration
  • Implementation and maintenance of study structure
  • Elaboration of required study documents (observational plan, CRF templates, patient information, safety management plan etc.)
  • Supporting and overseeing performance of involved company affiliates (e.g. organisational support of local regulatory processes, supporting selection of local CRO, etc.)
  • Coordination of set-up and implementation of electronic study systems (eCRF, study management system, automated reports systems etc.)
  • Definition and setup of the further study structure
  • Organisation and conduct of adequate study training
  • Coordination of reporting and communicating of study results under involvement of required functions (medical affairs, clinical affairs, statistics, pharmacovigilance, etc.)
  • Setup, maintenance and archiving of central study master file
  • Supervising involved CROs and other vendors
  • Ensure adequate time management

Job Requirements

  • Master’s degree or equivalent in life science
  • Experience or special training in clinical research / project management (in particular observational studies)
  • Excellent organisational skills
  • Strong communication (written and verbal) skills
  • Team player and ability to motivate others
  • Fluent English (oral and written)
  • Strong knowledge of MS office (Word/Power Point/Excel), IT affinity

Klingt das nach einer Perspektive? Dann bewerben Sie sich!

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