Clinical Leadership Role for Medical Writing and Clinical Reporting

3 days ago


Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

Leadership Opportunity in Global Clinical Reporting

You will lead a team of 7 dedicated employees as Director for Clinical Reporting, overseeing the global medical writing and clinical reporting function.

Your Responsibilities Will Include:

  • Management of the Clinical Reporting team, ensuring alignment with key stakeholders and optimal resource allocation to projects and tasks.
  • Coaching and developing employees towards successful task execution.
  • Ensuring employee goal setting, professional development, and training plans are met.
  • Coordinating activities with Global Clinical Development, Global Regulatory Affairs, Safety and Pharmacovigilance, Global Medical Affairs, and affiliate companies as appropriate.
  • Executing approved Clinical Development Plans and Regulatory Submission Plans according to timelines.
  • Ensuring global public disclosure activities for trials in ALK are executed according to requirements.
  • Participating in publication planning activities and supporting development of publication plans.

About You

  • A relevant educational background (MSc or PhD).
  • Broad experience within medical writing (at least 8 years).
  • Proven experience in people management, with the ability to inspire, mentor, and develop your team.
  • Thorough knowledge and experience with regulatory interactions (e.g. EMA, US FDA, CA HC, CN CDE or JP PMDA).
  • Knowledge about clinical disclosure requirements.
  • Developed collaboration and stakeholder management skills.
  • Fluency in spoken and written English and exceptional communication and writing skills.
  • Experienced IT-user skills.

Career Advancement and Benefits

ALK-Abello offers an attractive working environment for individuals looking for both personal and professional development.

Salary Range

We estimate a salary range between $80,000 - $120,000 per year, depending on location and experience.



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