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
Job Description:
Essential Function
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.
Relationships
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
Key Accountabilities
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.
Project management
* 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.
General management
* 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.
Line management
* 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.
Process improvement
* 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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Training
* Present details of technical courses attended or new knowledge acquired. Provide in-house training courses as required.
* Produce training material for and present external training courses.
* Keep abreast of new advances in medical writing and regulatory issues.
Client liaison/service
* Strive to ensure clients (internal and external) receive a quality product on time, all of the time.
* Be aware of client expectations for self and line reports. Respond appropriately to incidents of dissatisfaction, and feed back to MWS management if necessary.
* Provide support as appropriate to Account Management and MWS Management in their efforts to win new business.
* Attend business development meetings and prepare and make sales presentations to clients.
Resource planning
* Monitor resource utilization on MWS projects and compare projections to resource available.
* Maintain an ongoing understanding of departmental workload and resource availability. Use this knowledge both to identify potential resourcing problems with sufficient time to allow implementation of solutions and to indicate availability / ability to handle upcoming work to potential clients.
Proposals
* Provide input into assigned full-service client proposals. Attend proposal meetings. Estimate the hours required to complete each task. Provide a description of the medical writing services to be performed. Liaise with the proposal team and/or client to ensure that the proposal covers all services required.
* As required, co-ordinate the development of assigned standalone proposal documents, bringing together information from other departments. Estimate the hours required to complete each task. Provide a description of the medical writing services to be performed. Provide draft proposal to MWS Operational Management for review. Liaise with the client to ensure that the proposal covers all services required.
General
* Perform other tasks appropriate to a more senior position as required, with adequate support and under supervision.
* Other roles may be allocated in exceptional circumstances.
* Be able to provide short-term `basic* cover for absence of other MWS management.
* Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
* Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
Skills:
* Excellent interpersonal, negotiating, verbal and written communication skills.
* Professional attitude.
* Client focused approach to work.
* Client liaison.
* A flexible attitude with respect to work assignments and new learning.
* Logical thinking.
* Attention to detail.
* Self-motivated to work consistently in a fast-paced, rapidly changing environment.
* Able to work independently.
* Able 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.
* Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company.
* Supervision/ demonstrated understanding of people management.
* Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
* Project management (planning and monitoring).
* Business awareness/ business development.
* Knowledge of resource management and productivity metric management.
* Advanced word processing skills, expertise in Word for Windows, ability to understand and adapt to various IT systems.
* Ability to travel.
Education: Bachelor's degree in Life Sciences/ Health Related Sciences or equivalent.
Language Skills: Fluent in written and spoken English.
Minimum Work Experience: Broad experience in management of complex medical writing projects, including phase III. Previous line management experience, or equivalent, preferably in a billable service industry.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 28th Feb, 2013
Req Number: pare-10024363
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