Regulatory Information Associate

Description 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.



Title: Regulatory Information Associate
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02090

Position Summary:

The Regulatory Information Associate oversees the daily operation and maintenance of the electronic regulatory repository or EDMS, and ensures that official paper regulatory files are maintained, according to regional agency requirements. Ensure the appropriate indexing of all documents, including relationships and document lifecycle management, to insure that subsequent searches are successful.

Major Duties and Responsibilities:

Manages regulatory files by overseeing the indexing and maintenance of electronic and paper documents

Provides regulatory searching expertise in support of Regulatory Affairs by performing complex search and retrieval functions on the official regulatory repository or EDMS

Provides submission history information on all MedImmune products

Represents regulatory information area, when needed, in any submission related working groups that may need their expertise to support submission activities

Supports the regulatory staff in submitting documentation to regulatory agencies, including the preparing, copying and shipping activities required

Supports Regulatory Affairs by indexing documents and filing within the Document Control Room (DCR)

QCs archival documents for inclusion in regulatory submissions as needed

Adheres to official retention and archiving schedules for the DCR

Maintains document archival workflow, as it pertains to archiving and filing in DCR

Supports Regulatory Affairs on all Due Diligence activities as required

Supports the Legal department with discoveries, as they pertain to Regulatory issues

Responsible for quality control of all documents, both paper and electronic, prior to entering the Regulatory Archives, to ensure accuracy and consistency

Responsible for the daily production and submission to Agencies of all maintenance dossiers e.g. Protocols, Amendments, Safety Reports, Annual Reports, etc.
Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors

Supervision: Manages and coordinates the archival/retention/storage of paper and electronic records for the department
Education:

Undergraduate degree in Information Science, Business, English, Communications or related field, or relevant experience

Requirements Experience:

Two years of Pharmaceutical experience

Knowledge of document management technology and electronic publishing preferred

Skilled in using desktop applications

Skilled in indexing Regulatory documents

Experience in organizing discovery processes

Good knowledge of indexing methods

Good understanding of regional Agency regulations and submission process

Ability to work under pressure and adhere to deadlines

Skilled in managing multi-project tasks

Must demonstrate the following job competencies: results orientation; thoroughness, critical information seeking, concern for impact, concern for standards



If you are interested in this position please -
Apply online at www.medimmune.com/careers and search for Req #. 02090
MedImmune 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.