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Manager of Medical Writing

Exciting medical writer leadership position in an innovative biopharmaceutical company 

 

As Manager of Medical Writing at Orphazyme you will lead a team of 3 experienced Senior Medical Writers. You will be responsible for managing the current team members and for continuing developing the Medical Writer team’s strategy and processes. Furthermore, you must support the medical writing activities and provide medical writing insights to the development projects in close collaboration with the Medical Writing team.

With direct report to Head of Global Development Operations.

Your main tasks are:

  • Set and align the strategy for the Medical Writing function at Orphazyme to ensure its fit for supporting Clinical Development
  • Provide support to other functional areas with medical writing expertise
  • Support ad hoc on abstract and publication writing
  • Lead the daily operation of the function
  • Be part of the Global Development Operations leadership team
  • People management: Lead and support the employees in their daily operations in alignment with the Medical Writing strategy and company goals. Ensure knowledge sharing and collaboration within the Medical Writing team
  • Resource management for medical writing tasks
  • Coordination and preparation of medical writing tasks
  • Provide input to authority interactions and support regulatory submissions in collaboration with the Medical Writing team
  • Preparation and/or oversight of regulatory clinical documents
  • Review of relevant clinical trial documents
  • Participate in vendor selection
  • Involvement in data posting on registries or QC of data postings
  • Comply with Orphazyme’s policies, procedures and applicable external regulations
  • Provide input and support to SOPs, procedures, improvement initiatives, vendor governance and operational excellence

Your qualifications are minimum 8-10 years of experience as a Medical Writer within the pharmaceutical industry and preferably experience with writing clinical dossiers and briefing packages. You must have experience and insight into regulatory framework and requirements within medical writing and communication and be interested in driving Orphazyme’s responsibilities within e.g. transparency obligations, registries, lay man summaries and IB updates.

It is crucial that you can drive, manage and write concise and targeted regulatory, scientific documents in collaboration with many stakeholders. Experience with managing CROs is an advantage. Moreover, you must have good analytical skills and the ability to work with large amounts of information. Finally, you must possess excellent communication, presentation, negotiation and collaborative skills.

You have a Master’s Degree within science including skills within scientific research methods.

You are self-driven and able to take responsibility for your own projects. It is crucial that you are proactive and can work independently. You must work in a structured way with an eye for details and be able to motivate others and set the direction. You must be systematic/organized and set high quality standards. Furthermore, you must be flexible and open to challenges. It is important that you thrive in a dynamic and entrepreneurial research environment and are passionate about working in a novel therapeutic area.

Orphazyme offers a unique opportunity in a company with an exciting pipeline and a positive and informal environment. Orphazyme is growing rapidly and the rate of change is high and hence the opportunities to contribute and influence are many.

Travelling: Limited.

Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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