Contract position: A Technical Writing Consultant is needed for a leader in electronics, healthcare, and lighting in the Fremont, CA area. This position is responsible for Regulatory/Clinical writing assignments, supporting the writing of CSRs, Protocols, IBs, Summaries of Safety and Efficacy, Responsible for the preparation of documents across all phases of clinical development. No per diem available. No travel required. 1st shift position: 8:00 AM to 5:00 PM. Responsibilities for the Technical Writer
Requirements for the Technical Writer
- Contribute to clinical studies across several therapeutic areas, Assist with documentation for pre-submission and submission packages, as required.
- Develop, maintain and update templates for clinical documents including protocols, clinical study reports, investigational brochures, Integrated Summaries, literature reviews, and associated documents.
- Collect data by interviewing technical and process specialists, researching written material, attending training and demonstrations, using products, and observing users.
- Bachelor's degree in a scientific/technical field with at least 20 years of professional experience in a relevant role.
- Experience writing regulatory submissions such as NDAs/INDs,BLAs. Strong knowledge of FDA, ICH, ands GCP guidelines. Regulatory/Clinical writing experience.
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
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.