Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Regulatory Medical Writer

Company: PAREXEL
Location: Uxbridge, England,United Kingdom
Reference: 38976BR
Closing Date: 15 Feb 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

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. ...

Requirements:

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. 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. 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. 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.
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.


Qualifications

  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
  • Clinical research/medical writing experience: experience, including phase III, in writing multiple clinical study reports, and either CTD documents or similar, or study protocols.

Apply for this job: Senior Regulatory Medical Writer

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
Advertisement

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.