undergraduate intern - junior/senior level - global regulatory publishing intern.

job summary:
As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global biopharmaceutical leader focused on improving patients' lives. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare industry. This company is dedicated to developing life-changing medicines in neuroscience, oncology, and rare diseases, driven by innovation and cutting-edge research. With a strong legacy of scientific excellence and a mission to address unmet medical needs, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!

 
location: Telecommute
job type: Contract
work hours: 9 to 5
education: Bachelors
 
responsibilities:
- Collaborate in submission teams, to assist planning and execution of timely regulatory submissions primarily in eCTD format in support of investigational and marketed products.

- Represent Global Regulatory Publishing as subject matter expert on regulatory teams and project teams

- Ensure compliance with global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, and ICH for regulatory submissions.

- Contribute to submission plans to develop, track, and report on submission deliverables for all submissions

- Facilitate submission QC and issue resolution for regulatory submissions and documents with stakeholders

- Identify potential risks to submission plans, escalating appropriately

- Support report publishing, QC, and signoff utilizing templates and eSignature technology in accordance with company process and standards

- Assist in development of documentation including job aids or best practices.

- Maintain records and data in Regulatory Information Management (RIM) system

- Performs other regulatory related duties as assigned

 
qualifications:
- Interest in creating and publishing of regulatory submissions for Investigational (IND, CTA, etc.) or New Drug Applications (NDA, BLA, MAA, etc.) to Global Health Authorities in eCTD format

- Ability to research and interpret global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada and ICH

- Technical proficiency that would position candidate to quickly learn industry recognized tools including eSubmission gateway, DXC ToolBox, , Lorenz docuBridge, Accenture Starting Point templates, and Veeva Vault

- Excellent verbal and written communication skills

- Ability to work independently with moderate supervision on multiple projects simultaneously

- Strong team building skills and exemplary written and verbal communication skills.

- Detail oriented with creative problem solving and troubleshooting skills

- Enrolled in program progressing toward BS/BA.

 
skills: NDA, FDA, Maa, CTA, 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.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.