Regulatory Affairs Specialist - SubmissionsPosted: November 15, 2009
Position Summary The Global Regulatory Affairs Submissions Specialist maintains control and access to all Bausch & Lomb Pharmaceutical Regulatory documents. Specific Job Duties ? Oversee the maintenance and controlled access of regulated records, documents, and files ? Maintain a master list of regulated records, documents, and files ? Promote compliance with Bausch & Lomb policies, standards, and procedures for records management ? Archive documents according to archiving and document retention strategies Technical Competencies ? Knowledge of good documentation practices and requirements for managing regulated records ? Capable of utilizing IT systems supporting regulatory affairs such as document management, electronic publishing, and submission systems (e.g., Documentum, OpenText) ? Ability to influence and partner within regulatory and with cross-functional teams in a global pharmaceutical organization ? Ability to assess project risks and where appropriate, recommend contingency plans and strategies to mitigate risks ? Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project) Professional Competencies ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Capability to contribute to a team environment ? Strong communication skills Please refer to job code 750394 when responding to this ad.
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