Medical Writing Manager

  • Salary: 40,000 - 50,000
  • REF Number: 00034725
  • Consultant: Hendre Moolman
  • Contact: 01438 842 970
  • Date Published: 05.01.2016
  • Closed Date: 12.05.2016
  • Sector:
  • Location: Surrey,
  • Discipline:

Hendre Moolman at CK Clinical is recruiting for a Medical Writing Manager on behalf of our client, a Medical Writing Consultancy based in Surrey. Role is office based and permanent.

Main duties and responsibilities: Responsible for the day-to-day management of the medical writing team, including provision of support for the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Addenda to Clinical Overviews, Risk Management Plans (RMPs), SAE narratives, ad-hoc safety reviews/summaries, Benefit-Risk Assessments, as well as other safety and regulatory documents. Support the Managing Director in business development activities.

Job Description:

  • Manage day-to-day workflow of the medical writing team.
  • Lead the medical writing team in the production of regulatory and safety documents.
  • Provide scientific and strategic direction to support existing clients.
  • Provide scientific and strategic direction to support business development activities.
  • Function as the medical writing lead on a variety of projects.
  • Provide oversight for the medical writing team's adherence to SOPs and quality control processes.
  • Estimate writing hours for new projects.
  • Manage the medical writing team's workload and resource allocation for new projects.
  • Interact and liaise directly with clients and other industry professionals.
  • Monitor for changes in regulatory guidelines and ensure SOPs are updated accordingly.
  • Provide training on regulatory updates and SOP updates.
  • Support with the creation of report templates, review forms and guidance documents.

Key Requirements:

  • Science degree or higher (MSc or PhD preferred).
  • Extensive experience in medical writing, including the preparation of safety documents.
  • Ability to undertake quality review of documents to ensure medical writing standards and regulatory compliance.
  • Good training and mentoring skills.
  • Ability to think strategically.
  • Flexible attitude to handle constantly changing timelines and priorities.

For more information or to apply for this role, please contact Hendre Moolman on 01438 842 970 or email hmoolman@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34725 in all correspondence.

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