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Clinical Trial Application Coordinator
Ref No.: 18-02044
Location: Waltham, Massachusetts
Position Type:Full Time/Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:Medical Insurance
Clinical Trial Application Coordinator
Waltham, MA
Contract Duration:  Through end of year

This regulatory affairs job is responsible for coordinating the regulatory clinical trial applications (CTA) submission activities for assigned clinical trials.
This role is 100% onsite

Candidate must have experience in global regulatory CTA submission regulations, requirements and will be responsible for the global CTA submission strategy, as well as managing Contract Research Organization.

Job Responsibilities:
• The Regulatory Clinical Trial Application Coordinator will represent Regulatory Affairs in the study management teams. This will include providing regulatory strategy and overseeing activities conducted by the contract Research Organization

• Will facilitate the gathering of or author documents to be included in the clinical trial application

• The Regulatory Clinical Trial Application Coordinator role will be the primary contact point between Regulatory and the CRO for the management of submissions of CTAs.

• The Regulatory Clinical Trial Application Coordinator will ensure that the submission and approval events are tracked and the Master File is maintained.

Education, Skills and Experience:
• Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is preferred

• Proven experience in preparing and making clinical trial applications outside of the U.S.

• Familiar with the Clinical Trial Directive in the European Union

• Knowledgeable with scientific terminology.

• Ideal candidate would possess proven experience within regulatory affairs in the pharmaceutical industry.

• An understanding of drug development, clinical trial authorization applications, Regulatory Affairs, and associated regional and national requirements for conducting Rest of World clinical Trials

• Must have strong communication skills (written and verbal)

• Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).

• Ability to lead complex projects and a high degree of problem solving capability required.

• Must be able to work independently, strong initiative.

APPLY NOW!  
To Apply for consideration please apply through this job board or send your resume to Regina Jarrell at Regina.Jarrell@onboardusa.com  and reference job #558122 in the Subject Line.  If you meet the requirements above then I will likely contact you to assist you in becoming a candidate.

Disclaimers
You cannot be begin a job with our client without successfully passing their standard pre-employment drug screen and background checks
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
 
If this position is not quite for you, please still email your resume to onboardusa@jobdivaemail.com and your resume will be captured by our recruiting team and you will be contacted for future similar openings with our clients that might be a better fit for you. We look forward to helping you in your professional career!