HEAD OF MEDICAL WRITING
BRIEF COMPANY PROFILE
Our client is a global, research-driven pharmaceutical company focusing on the development of prescription-only-medicines, and they are a global market-leader within their therapeutic area. The company headquarter is in Greater Copenhagen, Denmark with subsidiaries, production facilities and distributors worldwide.
The Head of Medical Writing will lead a team of five Medical Writers and will be overall responsible for the Global Medical Writing function. Moreover, the role will take a seat on the GCD leadership team and will be responsible for ensuring the fulfilment of medical writing commitments as well as contributing to a positive working environment, including high employee satisfaction. A key task of the role will be to take leadership of the team, ensure alignment with key stakeholders and provide optimal allocation of medical writing resources to projects and tasks while coaching and developing employees toward successful task execution.
Head of Medical Writing
Senior Director, GCD
Limited (10-20 days per year)
Responsibilities & Tasks:
• Part of the GCD leadership team.
• Ensuring effective allocation of medical writing resources to projects and tasks.
• Responsible for managing, coaching and developing the team of Medical Writers – hereunder:
o Yearly appraisal/performance goals.
o In collaboration with the employees, planning of their training (courses and congresses).
o Ensuring personnel files are maintained and updated.
• Participating in publication teams and supporting planning of publication plans.
• Participating in PubRC activities, and when needed, giving input to publications prepared by investigators and CROs.
• Ensuring continued collaboration across functional areas.
• Taking overall leadership of various medical writing activities:
o Integrated Clinical Trial Report:
o Driving and preparing Clinical Trial Reports
o Reviewing of the Statistical Analysis Plan (SAP).
o Ensuring effective collaboration with CRO's with respect
to preparation and review of outsourced ICTR's.
o Clinical regulatory documents:
o Driving and preparing clinical summary documentation
i.e. Clinical Summary, Clinical Overview, PIP’s, briefing
documents and otherdocuments used for regulatory
submissions, other communication with regulatory
authorities and other documents/communication to be
used for regulatory purposes.
o Ensuring consistency between ICTR’s and the final
o Investigator’s Brochure (IB) and Investigational Medicinal Product
o Driving and preparing/updating the IB and sections of the
o Ensuring consistency between the various clinical documents,
the IB and the IMPD.
o Quality Control (QC):
o Contributing to ensuring timely QC of all relevant mentioned
documents prepared by a Medical Writer, Principal Medical
Writer or a Senior Medical Writer employee.
o Ensuring that updated SOPs related to Medical Writing e.g.,
ICTR and IB SOPs are in place.
o Contributing to training of Medical Writers, Principal Medical
Writers and Senior Medical Writers in these SOPs.
o Informing other relevant functions in-/outside GCD about the
o High-priority documents with clinical relevance:
o Preparing misc. high-priority documents in collaboration with
internal and external stakeholders/customers, input to stock
exchange messages, input to press releases etc.
• Sharing of relevant knowledge within GCD and other of our client's stakeholders.
• Coordinating and ensuring public disclosure activities for
clinical trials at our client's company.
Key success criteria:
• Ensuring optimal allocation of medical writing resources to
projects and tasks while securing high quality team output.
• Ensuring a high level of employee satisfaction.
• Ensuring effective collaboration with external stakeholders
(e.g. CRO’s) and internal stakeholders (e.g. Medical &
Science, Clinical Project Management, Biometrics and Regulatory Affairs).
• Successfully driving a high-performance culture open to
feedback within the MW team.
Preferably degree at Ph.D. or M.Sc. level within Pharma, Biology,
Chemistry, Medical Engineering or equivalent.
English – fluent, verbally and written.
Ideal experience and competencies:
• +5 years of experience within Medical Writing from a
Pharma/Biopharma/Biotech/CRO setting, or similar.
• Experience with regulatory interactions (e.g., EMA & FDA)
• Experience with project leadership and/or people
• Solid knowledge of GCP/ICH and other relevant
• Good knowledge about the Clinical Development process.
• Well-versed in project management.
• Experience in use of computers and relevant programs.
Possesses the courage to make decisions while making sure
employees and co-workers have a clear understanding of the
direction of the tasks. Takes action, organizes resources and
direct others toward successful execution. Drives projects
forward to reach pivotal objectives, makes things happen and
Possesses excellent medical writing skills with a high level of
proficiency in English. Produces written material that is clear,
fluent and appropriate for regulatory submissions or similar.
Works systematically, organizes work and effort, is methodical in
one's performance and holds on to commenced tasks/projects.
Plans a focused course of action for self and others, ensures
appropriate project management and schedules an optimal use
of available resources.
Inspiration and motivation
Inspires others and encourages the achievement of set goals by
promoting a sense of purpose. Provides inspiration for a
positive work attitude and prompts a strong wish to succeed in
Is agile and handles multiple priorities while being conscious of
time in relation to work and effort. Plans tasks in relation to time
spend and meets deadlines.
Builds bridges and works well with others with a view to obtain
common objectives. Shares information, resolves issues and
improves efficiency through strong stakeholder focus and
management. Supports others and acts in a highly professional
manner – seeing solutions rather than limitations.