Regulatory Affairs - Labeling - ClinicalPosted: November 5, 2009
Jobs Clinical Maryland Regulatory Affairs - Labeling Regulatory Affairs - Labeling Company: Aerotek Scientific Location: Gaithersburg, Maryland Category: Clinical Jobs Rate: Based on experience. Job Type: Contract Posting ID: 1995759 Posting Date: 11/3/2009 Allegis Group Family of Hiring Companies Apply Online for this Job Today Already a Member? If youre currently a thingamajob.com member? Please apply here. Apply with Your Account Not a Member? Were hiring. Create an account and you can apply for some of the most desirable Clinicaljob opportunities in the country. Apply with a New Account Regulatory Affairs - Labeling Job Description: Aeroteks client located in Gaithersburg, MD is looking for a candidate who will be responsible for the following: Major Duties and Responsibilities: 1. Provide support to RA-Labeling to ensure regional submission timelines are met, ie, support the creation, approval and implementation of labeling content and/or printed labeling in collaboration with various functions for assigned products 2. Interact with appropriate functional groups to obtain labeling annotations and supporting documentation 3. Ensure proper version control and labeling document integrity 4. Originate precedent searches and assist in analysis of competitive labeling 5. Provide operational support including but not limited to proofreading, translations, preparation and review of annual reports, SPL, final printed labeling. 6. Assist Regulatory Affairs-Labeling staff in resolution of all labeling issues as needed 7. Help ensure corporate quality standards for prescribing information are met 8. Represent RA-Labeling on relevant functional teams under direction of supervisor 9. Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function 10. Assist in other labeling initiatives and/or regulatory activities as required Required Skills for Regulatory Affairs - Labeling Job: * GMP * FDA * PRODUCT LABELING 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, were 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 its more than just your day-to-day responsibilities that can make or break a job. Its the support you get. Thats the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Dont 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. Contact Information Greg R. Greenberg Apply Now! Begin by filling out the "Apply Online for this Job" section at the top of the page Need Directions? Get office driving directions with Google Maps ggreenbe@aerotek.com Aerotek Scientific - Rockville, MD 2400 Research Boulevard Suite 120 Rockville, MD 20850 TEL: (301) 315-1822 FAX: (301) 315-1890 Please refer to job code 1995759 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
|
> Regulatory Affairs
| | Location: | Gaithersburg, MD | | County: | Montgomery County | | ZIP Code: | 20877 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | Aerotek | | Phone: | email only please | | Fax: | email only please |
|
