Medical Writing Manager

Medical Writing Manager

UK or US - home based or office based

This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON’s Clinical Research Services group. Our remit is to produce high quality clinical/regulatory documents supporting Phase II-IIIb studies and regulatory submissions.

Our key department values are:

• Passionate about partnership
• Quality without compromise
• Flexibility in a dynamic environment

We have an opening for a Medical Writing Manager to join us in Europe. The position could be home-based or office based.

In this role you will have the following responsibilities:

• Preparation and QC of clinical and regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Aggregate Reports, and Manuscripts. This includes:
• Working with internal study teams and clients to determine/clarify project requirements and obtaining necessary information.
• Understanding of contractual documentation and pricing tools.
• Tracking and recording progress against contracted hours/budget using financial tracking tools and the department’s project database. Early flagging to management of projects not on track and facilitation of the Change Order process.
• Attendance at internal and external projects meetings either face-to-face or (usually) via teleconference/Webex.
• Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance.
• Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments.
• Liaison with publishing colleagues on the creation on submission-ready versions.
• Perform QC of documents written by other writers.
• Line management of ~5 Medical Writers.
• Oversight of a portfolio of clients including ensuring that assigned writers deliver projects to a high quality, and within timelines and contractual obligations.
• Review of the quality of documents written by other writers with appropriate feedback/training that facilitates development of the writer’s competencies.
• Liaison with sponsors and ICON colleagues, e.g., Project Managers, Business Development and Contracts colleagues, with regard to new business proposals, costings and awards, including attendance at Bid Defense Meetings.
• To keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
• To lead department initiatives, as required, e.g., development of a new business area, implementation of process improvements, training.
• Assistance in achieving the department's strategic business targets, e.g., sales, revenue, utilization, growth, outward-facing leadership and talent development

Skills & experience required:

• Bachelor’s degree in a life science.
• Experience as a clinical/regulatory Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Aggregate Reports, and Manuscripts.
• Wider oversight/coordination responsibilities beyond writing individual documents, e.g., managing large programs of work or client oversight.
• Excellent verbal & written English.

Benefits of Working in ICON

Other than working with a phenomenal team of passionate and ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

Would you like to find out more before applying? If so, please contact one of our Talent Acquisition Specialists who will be very happy to speak with you.

ICON is an equal opportunity employer – M/F/D/V and committed to providing a workplace free of any discrimination or harassment