CMC Project Manage
Proclinical is currently recruiting for a CMC Project Manager with a biopharmaceutical company located in North Chicago, IL.
- Work proficiently in the document approval and archiving repository.
- Work with regulatory operations in providing the appropriate documentation for the global roll-out of the CMC Variation.
- Work proficiently in a document approval and archiving repository.
- Ensure submission documents are submission-ready formatted.
- Interfaces with Operations CMC Team and Quality Assurance.
- Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels.
- Communicate to the Regulatory Affairs (RA) CMC Project Lead any questions or concerns for meeting the timelines.
- Balance multiple priorities in a fast-paced, team-based environment and work independently when needed.
Skills and Requirements:
- Required: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
- Scientific background and knowledge of project management is desirable.
- Quick learner of technology applications.
- Expertise in MS Office applications including Excel, Word and Sharepoint.
- Excellent oral and written communication skills in English.
- Organization, attention to details and effective time management with an ability to adapt to changing priorities, excellent analytical and interpersonal skills.
- Competent in application of standard business procedures (standard operating procedures).
- Ability to work with minimal supervision.
- Learns fast, grasps the "essence" and can change course quickly when required.
- Preferred: Experience in pharmaceutical business and/or science
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.