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. ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment. Reference: 052743
Salary Range: NA
Minimum Qualification
8 - 10 years

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