Job Listing: Senior Regulatory Affairs Specialist

WE are looking for:

Position Summary:

A Quality Assurance/Regulatory Specialist provides administrative and technical review, editing, assembly, and filing of both hardcopy and electronic documentation and reports supporting new and on-going clinical trials. S/He assures that submitted information conforms to national regulatory guidelines. S/He may be requested to provide training based upon areas of expertise and to prepare documentation for and attend client/Agency meetings. S/He develops and maintains a current knowledge of domestic and international regulatory requirements. As a team member, s/he contributes to developing and implementing ideas to improve documentation processes, including the establishment of templates, standard operating procedures, and guidelines.


Qualifications:

Education:

Bachelor’s or graduate degree with a life science, biotechnology, or pharmacy focus, RAC certification highly desirable.

Experience:

At least three years experience working in the technical writing, clinical research, drug development, or pharmaceutical industry. Familiarity with regulatory guidelines associated with drug development. Experience performing or responding to or providing training in; audit preparedness and response (GLP, GCP), human subject protection guidelines, or other specialized regulatory areas (CMC, Pharm/Tox, preclinical, clinical protocol).

Skills:

Experience with the technical and administrative review of chemistry and manufacturing control, preclinical data, pharmacological/toxicological data, or clinical protocol sections of regulatory submissions
Fluency in English, strong grammar, syntax and technical writing skills
Familiar with biomedical, clinical, and analytical scientific terminology
Demonstrated problem-solving and data-interpretation skills
Proficiency in computer programs including Microsoft Office and Adobe Acrobat
Experience performing literature and database searches
Maintenance of professional standards in a service oriented environment
Good organizational and time management skills
Ability to pay attention to detail, strive for consistency and perfection.
Ability to meet tight timelines while maintaining accuracy
Ability to work within a variety of client-driven specifications

Required Skills for Senior Regulatory Affairs Specialist Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.