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: Senior Medical Writer
Job Description:
The 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
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Write clinical documents for submission to 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, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
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Act in the capacity of project manager/lead 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.
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Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership 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 leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
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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.
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Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
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Coordinate and conduct interdepartmental 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.
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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.
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Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.
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Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
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Initiate and participate in departmental or interdepartmental process improvement and training initiatives.
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Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
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Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.
Skills
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Excellent interpersonal, verbal and written communication skills.
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A flexible attitude with respect to work assignments and new learning.
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Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
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Extensive clinical/scientific writing skills.
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Advanced word processing skills, expertise in Word for Windows, ability to understand and adapt to various IT systems.
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Education
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Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
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Language Skills
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Fluent in written and spoken English.
Candidate Profile
Extensive experience in clinical research/medical writing mandatory: independent writing experience with CTD documents and submissions for marketing authorisation. Phase III experience in writing multiple clinical study reports, protocols and other advanced and complex regulatory documents.
Additional Information:
Location: India
Functional Area: Other
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 20th March, 2015
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