Kelly Services Regulatory Affairs Therapeutic Area Associate in Plainsboro, New Jersey
Kelly Services is seeking a Regulatory Affairs Therapeutic Area Associate for our client in Plainsboro, NJ . This is a six-month assignment covering for a maternity leave with possibility of extension. The target start date is late June. In general, responsibilities include completing forms, drafting cover letters, submitting investigations for clinical trials, electronic submissions to FDA. The hiring manager is looking for those experienced with Regulatory Affairs and clinical trials, candidates MUST have a science background
Details of job duties include:
As requested, find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.
Assist in preparation of regulatory documents.
Assist Manager/Director in review of labeling for marketed products and new products as assigned.
Assist more senior personnel in managing projects.
Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.
Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance.
Coordinate document submission in accordance with supervisor’s requirements & guidance.
Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions.
Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable. Use of templated correspondence as appropriate, ensuring that all new information is correct.
Prepare drafts of routine correspondence and ROCs for routine FDA contacts.
Review documents and information from local & NNAS contributing departments and provide comments to assure that documents are accurate and complete and comply with FDA regulations.
Bachelor's Degree required; Life Science preferred
Minimum of 3 years’ experience required (pharmaceutical industry, laboratory, or clinical research position)
Commitment to regulatory affairs profession
Effective personal time management
Excellent written skills
High commitment to quality of all assigned projects
Intermediate proficiency in Microsoft Office Suite required
Strong detail orientation.
Strong interest in continuous improvement and professional development
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
*perks to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
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With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.