| Company |
Mylan Pharmaceuticals Inc. |
|
| Location |
Morgantown, WV |
| Department |
Regulatory Affairs |
| Position Reference Code |
MPI_11_001663 |
|
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products
to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and
highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active
pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric
therapies. For more information, please visit www.mylan.com.
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Opportunity Profile:
The Regulatory Affairs intern will work under the direct supervision of Regulatory Affairs Labeling to perform all Regulatory functions pertaining to preparation/maintenance of the various types of drug product labeling.
Duties may include but are not limited to:
Creation and population of project database, electronic training manual and labeling components.
Maintenance of the labeling files, maintenance of the product labeling filing system, assistance with the preparation/compilation of various FDA labeling submissions.
Perform documentation development, assist with the preparation of labeling memos of various types and will help to gather the labeling requested by other departments.
Other labeling projects are assigned and completed as necessary.
The successful candidate will be responsible for handling components of electronic submissions to regulatory agencies. This position works under the supervision of Regulatory Affairs personnel to ensure the creation of quality submissions.
Duties may include but are not limited to:
Follow electronic documentation requirements defined for the submission process and create hyperlinks and bookmarks.
Perform documentation development, formatting and finishing, including publishing to Adobe Acrobat PDF or other established submission standards.
Scan, import or otherwise process submission content from various departments.
Work under the direct supervision of management to ensure the application of all related standards and policies.
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Reporting
Structure:
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Qualifications:
The qualified candidate will currently be enrolled in a degree seeking program at an accredited university, pharmacy or nursing programs are preferred. Prior pharmaceutical experience preferred but not required.
Must be detail oriented; possess strong organizational and multi-tasking skills. Basic analytical and problem solving skills are required.
Qualified candidates will possess strong working knowledge of Adobe Acrobat, Microsoft Word, Excel or Access.
Must be able to work flexible daytime hours between 8:00 A.M.-5:00 P.M. Monday –Friday.
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Educational
Requirements:
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Background
Requirements:
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At Mylan, we are not satisfied with anything less than being the best. As one of the world's leading
generics and specialty pharmaceutical companies, the key to our success starts with a relentless drive
to set the highest industry standards in everything we do. It takes exceptional people working together
to achieve excellence. As a team, we earn our customers’ trust and loyalty by placing a high premium
on always doing the right things in the right way.
Mylan offers competitive salary,
excellent benefits and an environment conducive to professional growth and advancement. Mylan is an
Equal Opportunity Employer, M/F/D/V.
Opening Up a World of Opportunities
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