Rotations

The Three Rotations

The programme is structured around three main activities within the development of new drugs split in 3 different functional units:

  • Global Development,?where trial protocols and development plans for new potential drug candidates are made and communication with the authorities concerning approval of trials and drugs is conducted.
  • Global Medical Affairs,?where input is given to the clinical development plans and product strategies. Publication planning, medical communication and data presentation are also anchored in the Medical Affairs rotation.
  • Global Safety,?where adverse events are assessed, safety reports are submitted to competent authorities and trial protocols are reviewed.

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Global Development

(By Azadeh Houshmand-?regaard and Eskil Brandt Kreiner, team 2016)

In Global Development, we as medical doctors are responsible for providing medical and scientific input to the clinical trials that are being run in our department.

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First of all, we are involved in the preparation phase of trials, where we give input to the trial outline which is a detailed summary of the rationale, objectives and overall design of the trial. We are also involved in the trial execution phase, where we present and share knowledge with doctors and nurses from various international sites where the trials are conducted, provide input regarding trial adherence, and answer any questions the sites may have regarding trial-related medical and safety issues. Upon completion of the trial, we add medical input towards analysis of results and drafting of conclusions.

At the trial initiation and finalisation phase, we provide medical input to health authorities in order for them to either approve the trial design or to approve our products for sale and marketing, respectively. On the side, we are involved in a wide range of academic and scientific settings where we interact with medical experts, and we provide internal input (within the company) regarding the design of clinical trials to be conducted in the development phase of a new product.

Global Medical Affairs

(By Mikkel Agersnap and Joshua Bilbie, team 2016)

In Global Medical Affairs, we as medical doctors are responsible for scientific communication, both internally in the company and to the scientific community.?

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We provide medical education and guidance and do so by developing online learning tools and preparing presentations for visiting physicians, affiliates (company departments in other countries), product launch presentations, and internal management presentations.

In this process we focus on how to communicate the data clearly and we provide input to and review slide decks and presentations. Furthermore, we have interactions with global scientific and clinical experts at Advisory board meetings where experts give their unbiased opinion regarding different aspects related to our products, at Investigator Meetings for people involved in running our trials, e.g. doctors and nurses, and at Result Meetings where trial results are presented.

In addition we interact with them at different congresses or symposia (e.g. American Diabetes Association and Global Diabetes Summit). We provide guidance on investigator sponsored studies (ISS) and are part of the publication planning group meetings and hence responsible for abstracts, papers and posters submitted to congresses and journals. In addition we have cross-sectional collaboration where we provide clinical and strategic input as needed e.g. for clinical trials and promotional materials.?

Global Safety:

(By Melissa Voigt Hansen and Cristina Parrino, team 2015, Parminderjit Kaur Jayia, team 2016)?

In Global Safety, we as medical doctors are involved in activities ensuring that Novo Nordisk products are of the highest quality and lowest risk to patients.?

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This includes preparation of reports, both internal and external (as Authorities request) that aggregate safety information (e.g. adverse reactions to drugs) regarding a specific product (e.g. Insulin Aspart). Our medical competencies are used to analyse, evaluate and conclude on the drug’s safety profile.?

We participate in meetings with colleagues from different departments regarding the clinical trials, providing feedback on protocol designs and informed consent forms prior to the initiation of clinical trials. We also attend Investigator Meetings where we inform the investigators participating in our trials about the specifics of the trial prior to its initiation. While the trial is on-going we present and evaluate blinded safety data to the study group (a group of people from different departments who meet at regular intervals regarding the specific trial). In addition we participate and contribute with input for e.g. Safety Committee meetings and meetings with Data Monitoring Committees.

We perform monthly literature surveillance and monitor recently published scientific articles regarding competitors and our products. In the market application process, we are involved in answering requests from authorities and preparing for advisory committees (panel of experts convened by authorities) if needed.

Prerequisite:

  • Medical doctor university degree
  • Passed post-graduate internship
  • 2-5 years of clinical experience (more experience,?click here)
  • No prior industry experience

With three rotations over two years, the PMP offers medical doctors a spring board to a life-changing career.?

What is the PMP?

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