Job Description
job summary:
The Principal Regulatory Medical Writer is a technical expert responsible for the authoring and coordination of high-quality, submission-ready documents. Unlike our communications-focused roles, this position sits at the intersection of clinical data and global regulatory requirements. You will ensure that all clinical study reports, protocols, and summary documents meet the rigorous standards of global health authorities while maintaining internal consistency across the filing.
location: Telecommute
job type: Contract
salary: $80 - 90 per hour
work hours: 9 to 5
education: Doctorate
- responsibilities:
- Document Authoring: Lead the drafting of complex regulatory documents, including Clinical Study Reports (CSRs), Protocols, Investigator's Brochures (IBs), and sections of the Common Technical Document (CTD) (Modules 2.5 and 2.7).
- Submission Strategy: Partner with Regulatory Affairs to ensure document messaging aligns with the overall submission strategy and successfully addresses health authority feedback.
- Data Integrity: Expertly interpret and summarize clinical data, ensuring 100% accuracy between the Statistical Analysis Plan (SAP), TFLs (Tables, Listings, and Figures), and the final narrative.
- Project Leadership: Manage the document review process, adjudicating conflicting feedback from multiple stakeholders (Clinical, Stats, PK, and Medical) to reach a consensus.
- Compliance: Ensure all deliverables strictly adhere to ICH G6 guidelines, AMA style, and internal company templates/SOPs.
- qualifications:
- Education: Advanced degree (PhD, PharmD, or MD) preferred; MS in a scientific discipline with extensive experience considered.
- Experience: 7+ years of primary regulatory writing experience within a Pharma or CRO environment.
- Submission Track Record: Must have played a lead writing role in at least one major marketing application (NDA, BLA, or MAA).
- Technical Skills: Mastery of document management systems (e.g., Veeva Vault) and advanced Word functions for large-scale regulatory templates.
- Therapeutic Expertise: Familiarity with Immunology or Oncology endpoints is highly preferred to align with current team pipelines.
- Precision: An obsessive eye for detail regarding data consistency and formatting.
skills: Medical Publications, New Drug Application (NDA), Biologics License Application (BLA), Marketing Authorization Application (MAA)
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 [email protected].
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.
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