Medical Writing Manager (remote-based)

Hobson Prior are currently looking for a Medical Writing Manager to work remotely for a pioneering CRO who provides outsourced development and commercialisation services to the pharmaceutical, biotech and medical device industries. This is a permanent position to be remote based either in Europe or the US.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to supervise Medical Writers and provide general assistance to the medical writing team.
• Communicate with sponsors, Clinical Project Managers, and new business personnel with regard to the availability of medical writing resources and the establishment of project timelines.
• Organise and maintain the medical writing work schedule.
• Assign suitably experienced Medical Writers to projects.
• Conduct performance reviews and discussions with line reports.
• Obtain project progress reports from the Senior Medical Writers and use this information to ensure the maintenance of document quality and project timelines.
• Write, perform internal reviews, and QC regulatory documents (eg, CSRs, protocols, IBs, periodic safety reports, INDs, eCTD/NDA clinical summaries) prepared by the medical writing team.
• Communicate with the cross-functional team to ensure the maintenance of document quality and project timelines.
• Inform the medical writing senior management team, when required, of the status of projects and, in particular, any issues that affect document quality and project budget.
• Any other assigned duties.

Key Skills:

• Excellent attention to detail and strong problem-solving skills.
• Demonstrated ability to work effectively and efficiently in a fast-paced environment.
• Strong communication skills.

Requirements:

• This position requires a BS in a scientific or medical discipline with relevant writing experience (advanced degree (MS/PhD) is ideal).
• You will have an in-depth understanding of regulatory/ICH guidelines and GCPs.
• 5 years medical writing experience (CSR's, Protocols, Aggregate Reports, Patient Consent Forms and IND)
• 1 years medical writing management experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.