Lead Medical Writer

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:Reporting to the Head of Medical Writing, the Lead Medical Writer will be responsible for leading the medical writing activities for multiple projects or a business unit. Responsible for timely preparation of investigators? brochures, study reports, integrated summaries, clinical overviews, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents, ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Supports the clinical project team(s) as the Medical Writing representative and oversees/coordinates work of other writers (internal or contractors). Leads efforts for establishing departmental guidelines and cross-functional initiatives. Responsible for resource assessments within assigned projects/business unit. Must be able to work with a high level of independence and effectively in a team environment, and must have strong scientific interpretive, organizational, and project management skills.? Responsible for all medical writing activities within assigned projects / business unit.? Actively support clinical project team(s), representing Medical Writing and bearing responsibility for timely and accurate MW deliverables, negotiating timelines and procuring resources as necessary.? With a high level of independence, write, edit, or otherwise facilitate completion of clinical documents (all document types).? Manage writing, editing, QC, and publishing activities for programs within assigned project/ business unit.? Delegate and manage clinical project writing activities assigned to contract medical writers? Proactively prepare writing plans for projects, including contingency plans and issue resolution strategies? Provide strategic direction to the clinical project team relative to consistency of key messages across documents within a project and regulatory requirements/guidance for submission documents.? Mentor supporting medical writers, and ensure the quality and timeliness of their deliverables.? Lead departmental and cross-functional process improvement initiatives.? Contribute to departmental strategic planning.Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? PhD or equivalent degree in a relevant scientific/clinical/regulatory field preferred? At least 7 years of broad range experience in clinical/pharmaceutical development? Global regulatory submission experience? Excellent writing skills. ? Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team. ? Strong oral and written presentation skills.? Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution).? Knowledge of current regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.? Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.? Working knowledge of template use for document creation. ? Ability to work with different template styles and types. ? Ability to prioritize multiple projects.? Document coauthors, reviewers, approvers; Leadership within CR&D; other functional areas including Pharmacovigilance, Medical Affairs, Marketing; contract writers and other functional area representatives from CROs.? Broad scope of clinical development, and comprehension of factors that could impact current plans? Ability to quickly adapt to changes in project plans to ensure writing activities are not negatively impactedApply to Shire