What are the responsibilities and job description for the Project Manager II position at Nextcode placement?
Job Title: Project Manager II (non-IT)
Duration: 12 Months
Location: North Chicago Illinois
Bachelor's Degree: Science
Regulatory submission documentation creation background
- Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.
- This position will coordinate activities with all functional departments in support of regulatory filings.
- Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Independently facilitate project team meetings.
- 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. Manage multiple projects simultaneously.
- Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
- Detail/accuracy oriented, collaborative and willing to learn
- Familiarity with US and other international regulatory requirements for dossiers
- 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)
RA Associate
- Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines.
- Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Skills for running review meetings for submission documents. Understand CMC expectations including CTD content, structural and formatting requirements.
- Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
Job Type: Contract
Pay: $30.00 - $33.00 per hour
Expected hours: 40.00 per week
Schedule:
- 8 hour shift
- Holidays
- Monday to Friday
Work Location: On the road
Salary : $30 - $33
