RA CMC Associate
North Chicago, IL 60045 US
Target PR Range: 30-40/hr
*Depending on experience
Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.
• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required Experience: 4 years pharmaceutical . 1-2 years cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
• Superior oral and written communication skills
• Ability to work cooperatively with all levels and types of global personnel required
• Experience working with electronic document management systems
• Ability to work independently under pressure and manage multiple projects simultaneously
• Detail/accuracy oriented
• Collaborative and willing to learn
• Familiarity with US and other international regulatory requirements for drug product dossiers
• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.
• Update simple CMC documents independently.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Independently run reviews meetings.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Timely communication of systems issues to management.
Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users. 1-6 years’ experience
*CO/NYC candidates might not be considered
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