Medical Writing Manager

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 on the East Coast US. The position could be home-based or located at our North Wales, PA, offices.

In this role you will have the following responsibilities:

Participate alongside 4 other Medical Writing Managers in the management of aspects of the Medical Writing department including, but not limited to:

•     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:

o   Working with internal study teams and clients to determine/clarify project requirements and obtaining necessary information.

o   Understanding of contractual documentation and pricing tools.

o   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.

o   Attendance at internal and external projects meetings either face-to-face or (usually) via teleconference/Webex.

o   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.

o   Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments.

o   Liaison with Publishing colleagues on the creation on submission-ready versions.

o   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.
•          General operational assistance to the Medical Writing team.
•          Assistance in work scheduling.
•          Active participation in all meetings.
•          Reporting of department metrics relating to quality, timeliness and productivity.
•          Achievement of individual utilization (billability) target.
•          Any other task deemed reasonable by department senior management.

Skills & experience required:

Essential:

•          Bachelor’s degree in a life science.
•          At least 7 years’ 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.
•          Able to assimilate and summarize large volumes of scientific data accurately, clearly and concisely.
•          Wider oversight/coordination responsibilities beyond writing individual documents, e.g., managing large programs of work or client oversight.
•          Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook. Able to rapidly learn to use bespoke in-house and client toolbars.
•          Excellent verbal English.
•          Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting.
•          Excellent attention to detail.

Preferred:

•          Advanced (post-graduate) degree.
•          At least 1 year’s line management.
•          Experience of working for a large CRO.
•          Familiarity with Veeva Vault, Salesforce and Box.

Competencies:

•          Able to recognize, exemplify and promote ICON's OwnIt culture and values of Accountability and Delivery, Integrity, Collaboration and Partnership.
•          Able to promote a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
•          Leadership skills.
•          Proactive, gracious and collaborative communication skills.
•          Able to work in a fast-paced, results-driven environment.
•          Culturally aware and able to work comfortably within a global team.

Other:

•        Travel (approximately 10%) domestic and/or international.

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.