job summary: Regulatory Affairs CMC Project Manager I
location: Lexington, Massachusetts
job type: Contract
salary: $53.45 - 62.88 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Manages multiple multi-product CMC focus global submission to ensure timely completion per established timelines.
- In consideration of health authority requests & program plans, create project plans with documentation requirements, timelines, and identified and monitor activities of key deliverables.
- Will work closely with project leads, but require the ability to work independently with minimal supervision.
- Requires excellent verbal and written communication skills, must be able to manage concurrent projects that may be unplanned, detailed oriented, and organized.
- May require internal and external interactions in support of project plans.
qualifications: Education & Qualifications
- Professional Degree and/or coursework (Chemistry, Biology, Biochemistry, Pharmacy, etc) and at least one year of regulatory related course work is preferred.
- Proficient in MS Office and experience in databases and electronic system is highly desirable
skills: CMC, MS-WORD, MS-EXCEL, MS-Powerpoint, GCP (Good Clinical Practice), Regulatory Affairs Operations, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.