Regulatory Medical Writer - Protocols/Immunology
We are seeking an experienced Regulatory Medical Writer to support a small biotech on a part-time contract basis. This role will focus on developing and revising protocols and amendments for three Phase III immunology studies.
Contract: Through 12/31/25
Hours: PT~10-20 hours per week
Rate: $110-120 per hour w2 only
Therapeutic Area: Immunology
Focus: Phase III protocols & amendments
location: South San Francisco, California
job type: Contract
salary: $110 - 120 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Draft, edit, and finalize clinical study protocols and amendments
- Collaborate with cross-functional teams to ensure clarity, accuracy, and regulatory compliance
- Provide strategic input on regulatory documents and study-related communications
qualifications:
- Bachelors Degree (minimum) MS or PhD in biological science preferred
- 6+ years experience writing high-quality clinical regulatory documents including protocols and amendments
- Pharmaceutical and/or Biotech industry experience required
- Experience writing and editing ICH-compliant clinical regulatory documents
- Ability to critically analyze, synthesize, and communicate/present complex scientific information
- Strong knowledge of CTD, ICH, GCP and other standards
- Ability to manage/prioritize projects from conception to completion in a fast-paced environment
skills: IND, NDA, Maa, GCP (Good Clinical Practice), CTA, CTD Structure
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
