As the largest staffing and recruitment agency in the world, we can commit to finding 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. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!
location: Cambridge, Massachusetts
job type: Contract
salary: $55.00 - 64.12 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The candidate will work as a liaison between stakeholders and vendors to derive information for the creation and editing of ECTD submissions, Acting as a quality control person on ECTD components, they will check the submission(s) for necessary bookmarks and relevant regulatory information as well as coordinate publishing with the vendor. They will be responsible for finding errors within the documents and follow up on corrections that need to be made prior to submission for publishing.
- Performs eCTD submission management across the company's product portfolio to global Health Authorities for both major submissions and lifecycle management.
- The Global Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products.
- Oversee outsourced publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products.
- Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle.
- Partners with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders.
- Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
- Drives deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality.
- Identifies and assesses impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.
qualifications:
- 5 plus years in Regulatory Operations.
- They must know regulations and have insight on what to look for in the ECTD documents.
- Must be knowledgeable with US region regulations with regard to ECTD submission,
- Must be able to meet deadlines and oversee deliverables on document submissions.
- Also, have the insight to find errors and follow up on correction of errors within the document.
skills: CTD Structure, 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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
