Medical Director, Neurology, Clinical Trials (remote work arrangements may be possible)
PAREXEL International - MA, US
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- Company
- PAREXEL International... PAREXEL International
- Location
MA, US
- Job Type
- Regular
- Job Classification
- not provided
- Experience
- not provided
- Education
- not provided
- Company Ref #
- 299513299513
- AJE Ref #
- 554710170
- [+] More
Job Description
Medical Director, Neurology, Clinical Trials (remote work arrangements may be possible)
Join an industry leader where you will provide medical leadership & guidance/consulting to assist in the development of new drugs. Provide medical & scientific support to manage clinical trials, assess medical drug safety, & act as the physician lead on projects.
Overall responsibilities of the Medical Director are to:
Provide medical monitoring for assigned projects; function as medical representative on the project team; provide medical consultation as required or requested to client/sponsor or to other PAREXEL service groups; & assume the role of Senior Technical Lead in selected circumstances.
Specific responsibilities include:
- Review all individual adverse experience reports for accuracy & clinical importance, & characterize their relationship to the study drug, severity & seriousness.
- Provide reports to FDA or other regulatory agencies & the sponsor on a periodic & regular basis, summarizing adverse experiences as required by FDA or the sponsor, depending on the contract.
- Review data listings of safety data, including adverse experiences, laboratory data, & vital signs data, to establish the presence or absence of abnormal trends, & if noted, follow up as appropriate with the project team, sponsor, investigator, & FDA.
- Review documents written by various PAREXEL divisions for safety issues.
- Review coding of adverse events & concomitant medications for accuracy & consistency.
- Provide support for the preparation of clinical protocols, integrated clinical & statistical summary reports, journal articles, & other documents for clients/sponsors or in conjunction with clients/sponsors & in conjunction with other PAREXEL divisions.
- Attend & present material, as requested, at meetings within PAREXEL as well as extra-company meetings (such as investigator meetings).
- Maintain up-to-date knowledge of projects by attending Professional Society Meetings.
- Provide support for Marketing activities as requested.
- Assume the role of Senior Technical Lead in selected circumstances.
- Provide medical consultation as required or requested to client/sponsor or to other PAREXEL divisions.
GROWTH:
While most companies were busy downsizing, PAREXEL added over 2100 employees in 2009 alone!!
PROMOTION:
In 2009, more than 1200 PAREXEL employees received career promotions!!
EXPERTISE:
PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best selling drugs that are on the market today.
AWARDS:
Scrip Award for Best CRO 2008,
BioSingapore Award for Best Performing CRO 2009, Good Clinical Practice Journal, Most Innovative Patient Recruitment Strategy 2008, Globe 100 - Top 10 Best-Performing Massachusetts-Based Public Company 2009 (including Top Employer Ranking by number of world wide employees)
Keywords: MD, physician, clinical, clinical trial, clinical trail, Internal Medicine, neurology
