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Medical Director

Employer
Parexel
Location
Serbia
Salary
Competitive
Start date
2 Jan 2023
Closing date
1 Feb 2023

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.

Key Duties Include:-

Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role

Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness

Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and 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, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, sponsor, investigator, and FDA

Review documents written by various Parexel divisions for safety issues

Review coding of adverse events and concomitant medications for accuracy and consistency

Provide medical expertise / leadership in Proposal Development Teams for client bid pursuit meetings

Provide medical expertise to client across multiple channels and interactions such as:

Consultancy on protocol development or drug development program

Medical review of various documents, which might be audited by clients and regulatory agencies

Provide medical expertise and training to other Parexel colleagues

As appropriate, write clear, concise medical documents and provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors or in conjunction with clients/sponsors and in conjunction with other Parexel divisions.

Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications, conference attendance, etc

Support Business Development as needed

Qualifications :

Successful applicants will be medically qualified based on successful completion of training at an accredited medical school and be Board-certified in Neurology w/ experience in Pediatric clinical patient care. Consideration will also be given to exceptional Adult Neurologists who possess the flexibility to serve as a medical monitor on both adult or pediatric trials. Past experience as a Physician in Industry or as a clinical trial investigator is preferred; however, strong candidates with an interest in clinical trials will also be considered.

Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts

Excellent time management skills

Excellent verbal and written medical communication skills

Excellent standard of written and spoken English

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.

@20% travel is required

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Find Us
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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