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Regulatory Associate I
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Regulatory Associate I : MedImmune, LLC.
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| Job Number |
02187 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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| Description |
Description
Title: Regulatory Associate I
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02187
Position Summary: The Regulatory Affairs Associate is responsible for collecting, preparing and assembling documentation required for DDMAC/APLB promotional submissions, in addition to completing final reviews of promotional labeling to ensure all edits are included. The RA associate will interact with other MedImmune functions, including Marketing Operations and Regulatory Operations on a regular basis in the coordination of submissions. Proof reading skills and attention to detail are key components of this position.
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
Major Duties and Responsibilities (including supervising others):
-Review all final promotional pieces to ensure accuracy
-Prepare appropriate documentation for regulatory submissions to DDMAC/APLB and work collaboratively with submissions publishing team for submissions to DDMAC/APLB
-Maintain Regulatory Files/Documents
-Assist with other Regulatory activities as required (e.g. assist with Warehouse Audit)
Special Skills/Abilities:
1. Attention to detail and accuracy
2. Able to multi-task
3. Proficiency in the use of Microsoft Word, Excel, Outlook
4. Self-motivated
5. Adaptability to changing regulatory environment
6. Team Player
Job Complexity: Receives minimal instructions on routine work and more specific instructions on new assignment.
Educational Requirements
Requirements/Qualifications:
Education: Undergraduate degree in English, Communications or related field
Experience: Documented experience in a regulated environment (e.g. regulatory affairs, quality assurance) preferably in promotion/labeling area. Work experience in a bio/pharmaceutical arena is highly desirable
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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