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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.
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Title: Associate I/II
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02094
Position Summary:
Responsible for the collection, evaluation, preparation and assembly of nonclinical, clinical and CMC documentation required for international (ex-US) marketing applications for vaccine products. Proactively identifies potential issues and recommends solutions to supervisor.
Major Duties and Responsibilities (including supervising others):
1. Prepares submissions to Rest of World (ROW) regulatory authorities to support international vaccine licensing initiatives, including identification and compilation of documentation, preparation of regulatory components (cover letter, forms, etc) and coordination of review, approval and submission of final dossiers.
2. Assists senior regulatory staff in reviewing submission documentation for consistency and compliance with applicable regulations and guidelines.
3. Interacts with project team members, including Project Management, Clinical Development and Operations, Quality, Research and Development as appropriate in the coordination of submission assembly, review, and approval.
4. Demonstrates a strong attention to detail and skill in preparation and review of submission to ensure high-quality. Must have the ability to manage multiple documents simultaneously; address problems of diverse scope; and work comfortably with all levels of scientific and other staff members. Understanding of international submissions processes and documentation requirements is preferred.
5. Reviews and determines the applicability, accuracy, and completeness of supporting documentation for inclusion in global regulatory submissions.
6. Remains current with all regulatory requirements and standards necessary to obtain and maintain international licensure for company products.
7. Ensure corporate and partner compliance with established company quality policies, practices, SOPs, and applicable US, EU and ROW regulations.
8. Responsible for the maintenance of regulatory documentation.
9. Must have excellent oral and written communication skills. |
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Special Skills/Abilities:
1. Able to multi-task
2. Act quickly in response to management objectives and changing project priorities
3. Self-motivated and proactive worker
4. Possess professional ethics
5. Excellent planning and organizational skills
6. Proficiency in the use of Microsoft Word and other software programs
7. Strong interpersonal /group skills with ability to direct, motivate and influence others
8. Capable of working collaboratively with colleagues in all functions
9. Ability to interpret, understand and comply with international regulatory requirements
10. Attention to detail and accuracy
Job Complexity:
Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.
Supervision:
Coordinates regulatory projects and initiatives under general supervision. |
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Requirements/Qualifications:
Education:
Undergraduate degree in a scientific discipline or equivalent experience.
Experience:
Minimum of 3 years of relevant experience in the pharmaceutical/biotech industry. Knowledge and understanding laws, regulations, and guidelines pertaining to international product registration and experience in vaccine product development and registration is highly desirable.
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| None Specified |
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