Work as Manager, Medical Writing Services in Parexel
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Manager, Medical Writing Services
The Manager, Medical Writing Services, will research, create, and edit documents associated with the clinical sections of regulatory submissions and other clinical documents. This is a billable position (65%). The Manager is also responsible for all line management of assigned medical writing staff, either at the local site or remotely. The Manager inputs to medical writing resources for proposals. The Manager provides project management of the medical writing aspect for their projects and those of their line reports.
Reports To Departmental Line Management
Directly Supervises Medical Writers
Provides Work Direction to Medical Writers
Works Closely with WW Senior Director, Head of WW Operations MWS, HR, Account Management, Proposals/Contracts, CRS Quality Management, MWS QM Specialist, RRC, Trainers, line managers in Biostatistics, Data Management, Medical Services, PAREXEL Consulting, Project Leaders, and Portfolio Directors
External Relationships Clients/potential clients, external consultants
Writing and consultancy
* Prepare, review, and edit key documents for regulatory submissions without the need for any supervision or formal training. Train self to prepare any type of medical writing deliverable.
* Provide technical leadership to ensure that clinical data presented in summary documents are in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
* Advise on medical writing regulatory issues and submissions as detailed in current ICH, FDA, EMA and other applicable guidelines.
* In line with client requirements, devise and prepare medical writing deliverables for which little or no regulatory or other guidance is available, e.g., risk benefit assessment reports.
* 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.
* Be the person ultimately responsible for Medical Writing aspects of assigned projects, without supervision.
* Set clear objectives for all Medical Writing team members and monitor performance against these objectives in an ongoing way. Provide leadership and strategic re-planning, delegation of responsibilities and tasks to team members. Monitor the progress of each individual project task and assess the overall program. Monitor overall project performance in an ongoing way and if necessary identify ways to ensure that the project is completed on-time and within budget. Keep client and project team informed of study status.
* Track actual versus planned project budget for entire Medical Writing portion of project. Determine the cause of cost over-runs and out-of-scope activities and recommend corrective action to medical writing management. Identify changes in scope as and when they arise.
* Provide updates for each project to MWS manager, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements.
* Attend managers meetings, and chair as invited.
* Sign off expenses/invoices/purchase orders/cheque requisitions for expenses for direct line reports, as authorised by line manager.
* Supervise and mentor assigned MWS staff, including all aspects of MWS personnel management, including hiring, training, professional development, performance development plans and annual evaluations, compensation recommendations, promotions, team building, morale, motivation, supervision of adherence to departmental QC procedures and health authority guidance and regulations, performance improvement plans, termination.
* Undertake the full range of duties relevant to the leadership, management and development of assigned staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
* Be familiar with all MWS Department SOPs and guidelines. Input into regular review of departmental SOPs and guidelines.
* Analyse efficiency of work and discuss improvement ideas with colleagues. Provide guidance to other members of the department on current medical writing issues and acceptable procedures.
* Attend external audits; respond to audit reports and follow-up on any issues highlighted.
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