Labcorp's Occupational Testing Services/Toxicology Division is seeking a Technical and Regulatory Writer for a collaborative, division-level role based in RTP, NC. This position supports multiple sites within the Toxicology Division and offers broad exposure to some of the largest clinical and workplace/forensic drug testing laboratories in the U.S.
The Technical and Regulatory Writer will be responsible for drafting documents in compliance with applicable state and federal regulatory guidelines. This role will also work closely with divisional technical leadership to help standardize technical documentation across sites and ensure documents are routed through the internal approval process using the divisional document control system.
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Work schedule: Monday-Friday 9am-5pm
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Responsibilities:
- Collaborate with Technical Departments across the OTS/Toxicology Division to draft a range of technical documents, including validation reports, validation plans, Standard Operating Procedures (SOPs), and other documentation related to analytical processes within divisional laboratories.
- Support cross-site projects throughout the division and maintain a data-driven project tracking system for document deliverables; proficiency in tools such as Smartsheet is highly preferred.
- Collect and organize validation data to ensure alignment with applicable regulatory standards and guidelines (e.g., CLIA, CAP, NYS, NLCP).
- Prepare comprehensive regulatory submission packets tailored to the requirements of relevant regulatory agencies.
- Demonstrate the ability to interpret clinical and forensic drug testing validation data and translate it into clear, site-specific technical reports that meet regulatory expectations.
- Draft additional regulatory and technical documentation as required.
- Manage document workflows through the Master Control System in accordance with site-specific procedures.
- Partner with the National Office of Quality (NOQ) to draft, edit, and finalize regulatory submissions for analytical methods, ensuring alignment with internal quality standards.
- Contribute to divisional documentation standardization by working closely with Quality, Operations, and Technical Leadership across the OTS/Toxicology Division.
Minimum Requirements:
- Bachelor's degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements.
- Minimum of 2 years of experience as a scientific, technical, or regulatory writer in a corporate or laboratory environment is required.
- Strong verbal and written communication skills are required.
Preferred Qualifications:
- 1 year of clinical laboratory testing experience is highly preferred.
- Minor in Communications, English, or a similar field is a plus.
- Working knowledge or proficiency in Program Management Software like Smartsheets is preferred.
If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, apply today!
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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