Technical and Regulatory Writer

Labcorp’s Occupational Testing Services/Toxicology Division is seeking a Technical and Regulatory Writer to work in a highly collaborative divisional level role located in RTP, NC. This role is expected to support several sites across the Toxicology Division. The role offers a potential for the team member to have a broad exposure to some of the largest clinical and workplace/forensic drug testing diagnostic laboratories in the United States. This position is responsible for drafting technical and regulatory documents in alignment with the relevant state or national regulatory agency guidelines. The person in this role is responsible for collaborating with divisional technical leadership to work on standardization of technical documentation across the division. The role is expected to take the document through the necessary internal approval process on our divisional document control system (Master Control).

The schedule for this position will be: Monday-Friday 9am-5pm.

Responsibilities:

• Work closely with Technical Departments in the OTS/Toxicology Division to draft technical documents including validation reports, validation plans, Standard Operating procedures and other technical documents pertaining analytical processes in the divisional laboratory.
• This role will support projects across multiple sites in the Division.
• Gather and organize validation data to align with regulatory standards and guidelines (CLIA, CAP, NYS, NLCP)
• Prepare regulatory submission packets for relevant regulatory agency.
• A proven ability to understand and translate clinical and forensic drug testing validation data packets into technical reports which satisfy the site-specific regulatory requirements
• Draft other regulatory and technical documents as needed.
• Work on getting documents through Master Control Document Control process as applicable to divisional site.
• Work closely with National Office of Quality (NOQ) to prepare, review, edit and gain approval for regulatory submissions for analytical methods.
• Support divisional documentation standardization efforts by collaborating with Quality, Operational and Technical Leadership in 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.
• A minimum of 2 years of clinical laboratory testing experience OR as a Regulatory Writer required.
• Excellent verbal and written communication skills is required.

Preferred Qualifications:

• Minor in Communications, English or similar field is highly preferred.
• Experience in diagnostics or pharmaceutical industry with regulatory writing experience is highly preferred.
• Working knowledge or proficiency in Program Management Software like Smartsheet’s, is highly preferred.

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Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable.  For more detailed information, please click here. 

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