Regulatory Operations Associate job in Foster City, USA

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Officer /Associate, Operations, RA Intelligence

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a REMOTE Regulatory Operations Associate with a pharmaceutical company.

Job Responsibilities:

Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
Registration of new clinical trials on CTgov & ENCePP
Regular updates to protocol records on CTgov & ENCePP
Results posting for clinical trials on CTgov, EU-CTR, & ENCePP
Performs QC/editing of training manuals, business practices, checklist documents.
Supports continual improvements by evaluating disclosure business process and providing suggestions to enhance compliance and efficiency.
Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.
Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.
Has excellent verbal and written communication skills and interpersonal skills.
Has well developed computer skills including proficiency in Word, Adobe and Excel.

Skills and Requirements:

3+ years of relevant experience and a BS degree
Clinical R&D experience (e.g. Clinical Operations)
Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP)

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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