job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!
location: Cambridge, Massachusetts
job type: Contract
salary: $52.15 - 61.36 per hour
work hours: 9 to 5
The role will support Informatics with submission publishing tasks on an Ad-Hoc basis, including document formatting and upload, setting or QCing hyperlinks, participation in Submission Team meetings. In addition, the role will support the Global Regulatory Operations Informatics and Analytics group with oversight of Regulatory submission process management and metrics gathering.
- Analyzing requests to update regulatory tool configuration or data dictionaries for compliance with data governance standards. Contractor will research based on existing system values and report recommendations to Informatics team
- Participation in regulatory system implementation efforts on an as-needed basis. Attending workstream meetings with I&A Sub and assist with stakeholder interactions, eventually to attend substitute as needed
- Act as point-of-contact for business for compliance or workflow concerns, including late delivery of documents, process bottlenecks, etc. Document concerns and bring to Informatics team for analysis and potential escalation
- Formally gathering submission metrics numbers and detail from vendor, report back to I&A submissions team
- ?A few years of experience in publishing, regulatory operations; general regulatory experience
skills: Regulatory Affairs Operations, Submissions
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.