Medical Writing Manager

Full Time in Consulting
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Job Detail

  • Remote Work Yes

Job Description

I am representing a leading CRO who are looking for a self motivated, talented medical writer manager.

Why work with them?

If you are looking to be a part of a fun, personable company, where teams work closely with each other, enabling you to learn from some of the best minds in the business, ensuring opportunities for professional growth.

Contracted Hours.- 37.5 hours working week. Monday to Friday 9am to 5:30pm

They offer a competitive salary & holiday plus they have other flexible benefits which you can opt into.

The role:

The Manager, Medical Writing Services is responsible for line management of assigned medical writing staff, including development and retention, either at the local site or remotely. The Manager may research, create, and edit documents associated with the clinical sections of regulatory submissions and other clinical documents. The Manager provides project management of the medical writing aspect for their projects and those of their line reports.

You will be required to:

  • Supervise and mentor line reports, including all aspects of MWS personnel management: hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, team-building, morale, motivation, and supervision of adherence to departmental procedures and health authority guidance and regulations
  • Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working relationships that promote satisfaction and confidence
  • In the proposal generation process, provide strategic and project planning intelligence to MWS management for standalone through full-service medical writing activities.
  • Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall program.
  • Fulfill Subject Matter Expertise role for various topics, depending on interest and experience.
  • Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated.
  • Analyze efficiency of work: collect and evaluate metrics to identify need for improvement efforts in processes, staff educational activities, or to better meet client needs.

You will need:

  • Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.
  • Previous CRO or Pharma (CRO is strongly preferred) Medical Writing experience of writing, authoring, owning Clinical and Regulatory documents (Clinical Protocols, Clinical Study Reports, Safety Aggregate Reports, Informed Consents, Safety Narratives etc
  • PMW we would need at least 5-8 +years of demonstrable working experience as a MW
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
  • Broad experience in management of complex medical writing projects.
  • Understanding of people management: previous line management experience, or equivalent, preferably in a billable service industry.

We welcome applications from medical writers with any disease background experience.