A Top-Tier Global Pharma Leader is seeking a detail-oriented Medical Writing Operations Formatter for a 1-year contract. In this remote position, you will collaborate closely with Medical Writers and regulatory teams to format, review, and maintain submission-ready clinical documents and Clinical Study Report (CSR) Appendices within Regulatory Information Management Systems (RIMS).
location: Telecommute
job type: Contract
salary: $30.00 - 34.37 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Format, import, route, and publish clinical regulatory documents in RIMS while ensuring alignment with defined templates and eSubmissions standards.
- Coordinate and verify completeness of CSR Appendices and ensure proper document properties, metadata, and file-naming conventions are applied.
- Serve as a Subject Matter Expert (SME) on master file systems, formatting standards, report publishing, and CTD structure for cross-functional stakeholders.
- Proofread and process complex documents in MS Word to ensure accurate rendering to submission-compliant PDFs.
- Manage centralized mailbox requests, track project deliverables, and maintain key performance metrics.
qualifications:
- Bachelor's degree (BS or BA in English/Communications considered).
- 3 to 5 years of relevant pharmaceutical or biotech industry experience in medical writing, regulatory, quality, or clinical research.
- Strong proficiency in MS Word formatting, eSubmissions standards, CTD structure, and electronic document publishing.
- Proven organizational, time management, and interpersonal communication skills.
skills: CSR, Individual Case Safety Report (ICSR), Clinical Study Report (CSR), Common Technical Document (CTD), Electronic Common Technical Document (eCTD)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.
