Senior Medical Writer
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Key Accountabilities
• 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.
• 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.
• 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.
• 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/EMA/PMDA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
• 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.
• 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 and mock statistical output 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 Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
• Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
• Assist management as needed in reviewing requests 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 interdepartmental 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 ensure the appropriate transfer of that information to the department.
*LI-RN1

Qualifications:
Education
• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
Language Skills
• Fluent in written and spoken English and Japanese.

Minimum Work Experience
• Clinical research/medical writing experience: experience, including phase III, in writing multiple clinical study reports, and either CTD documents or similar, or study protocols.

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 clinical research, the drug development process, and applicable regulatory guidelines.
• Extensive clinical/scientific writing skills.
• Advanced word processing skills, expertise in Word for Windows, ability to understand and adapt to various IT systems.
 
Additional Information
Location | | | Kobe Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013


Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided
 

       

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