The BioPharma Technical Writer is responsible for developing, reviewing, and maintaining controlled documentation that supports validation and laboratory operation activities. This role ensures that standard operating procedures (SOPs), forms, protocols, and other technical documents are accurate, clear, and compliant. The Technical Writer collaborates with cross-functional subject matter experts to manage documents, support quality initiatives, and promote consistency and continuous improvement.
Technical Writer Duties Include but are not Limited to the Following:
BioPharma Technical Writer I
- Write and edit forms, protocols, reports, and procedures from existing templates under supervision.
- Analyze documents to maintain continuity of style and content.
- Perform updates and revisions to technical documents as instructed.
- Work with Scientists, Regulatory Affairs, and Research and Development in a collaborative manner.
- Other duties as assigned
BioPharma Technical Writer II
As above, plus:
- Mentor/train new associates.
- Write documents from templates with minimal assistance.
- Create/modify document templates as needed.
- Participate in additional training (specific technical/scientific writing, regulatory affairs, clinical trials, statistics specific scientific topics, etc.).
- Participate in additional projects such as process improvement initiatives, presenting at a departmental meeting, etc.
- Other duties as assigned
Basic Minimum Education Qualifications :
- Bachelor’s degree in medical laboratory sciences, biology, chemistry, or another relevant scientific discipline required.
- Additional education, training, or professional experience in technical, scientific, medical, or regulatory writing is preferred.
Basic Minimum Work Requirements :
BioPharma Technical Writer I
- In lieu of technical writing experience, a minimum of four (4) years of experience in a regulated clinical laboratory environment or four (4) years of experience in regulatory affairs and/or quality assurance may be considered.
- Knowledge of Good Documentation Practices (GDP) and regulated environments, including CLIA, CAP, and GLP preferred.
- Experience authoring, revising, and maintaining controlled documents such as SOPs, test records, validation reports, validation protocols, and summary reports preferred.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
BioPharma Technical Writer II
- In lieu of specific technical writing experience, a minimum of 3 years working in a regulated clinical laboratory and 3 years of technical writing experience may be accepted.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
The Ideal Candidate Possesses the Following: