Sr. Medical Writer

Job Category: Editorial/Writing Career Level: Experienced (Non-Manager) Location: Waltham, MA 02451           Job Description: PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 employees. For more information about PAREXEL International visit www.PAREXEL.com Essential FunctionThe Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other PAREXEL departments and clients to set and meet internal and external deliverable timelines, leadership, training and support of junior medical writing staff.Key Accountabilities' Write clinical documents for submission to North American and European regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, CTD clinical overviews and summaries, safety updates, integrated summaries of safety and efficacy.' Act in the capacity of project manager for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.' Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Management for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project manager including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.' Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.' Ensure document content and style adheres to FDA/EMEA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.' Coordinate and conduct interdivisional team review and sign-off of document deliverables according to PAREXEL guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.' Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.' Perform literature searches/reviews as necessary to obtain background information and training for development of documents.' Review statistical analysis plans to assist in determining appropriateness of content/format for clinical writing.' Attend internal technical team and client team meetings as required.' Provide training and guidance and act as a mentor to less experienced departmental members.' Supervise collection of materials by the medical writing administrative assistant or associate medical writer for assembly of client deliverables and for filing appropriately in Central Files, department project files and medical writing archives. ' Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.' Assist management as needed in reviewing request for proposal packages sent by clients to determine content and appropriateness of materials required for development of clinical documents.' Initiate and participate in departmental or interdivisional process improvement and training initiatives.' Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.' Keep abreast of professional information and technology through workshops and conferences, and assure the appropriate transfer of that information to the department.Skills' Excellent interpersonal, verbal and written communication skills' Client focused approach to work' A flexible attitude with respect to work assignments and new learning ' Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail' Willingness to work in a matrix environment and to value the importance of teamwork.' Team leadership skills. ' Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines. ' Extensive clinical/scientific writing skills.' Sound clinical foundation (e.g. knowledge of immunology, oncology, cardiology, etc.) is essential. ' Advanced word processing skills, familiarity with Word for Windows. Education' Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.Language Skills' Fluent in written and spoken English.Minimum Work Experience' Clinical research/medical writing experience: experience in writing multiple clinical study reports, and either CTD documents or similar, or study protocols. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2215198&boardid=749