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Technical and Regulatory Writer

2 months ago

Rtp NC United States Labcorp Full time

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 in a clinical lab or research setting is 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.

Our U.S. Personal Choice Benefits

We believe improving health and lives starts from within. Learn about our comprehensive U.S. Personal Choice Benefits program, including wellness tools and resources.

Live your healthiest life

We offer a range of medical, dental and vision plans as well as life insurance and short-/long-term disability coverage. As a U.S. employee, you are automatically enrolled in our No Charge Laboratory Testing program.

Enjoy paid time off

Our hourly team members enjoy competitive time off and paid holiday leave. Our salaried U.S. team members have the flexibility to request time away from work, without the limits of accrued hours or carryover limits.

Reach your professional goals

We're proud to support every step of your career with 100% tuition coverage, professional development programs, mentoring and career growth opportunities.

Make your money go further

We are proud to offer a $300 fitness reimbursement, discounts on products and services, such as WW (Weight Watchers), cell phone services, computers, auto/home insurance, identity theft protection, legal assistance and more.

Promote inclusion and diversity

Employee Resource Groups (ERGs) are an important part of our culture. Through our ERGs our employees build career development skills, experience developmental opportunities and partner with volunteer organizations to strengthen our bond with communities

Invest in your wellbeing

We offer solutions for maintaining mental health, including live and personal wellness coaching, free premium mental health app access and an Employee Assistance Program which provides 24/7 confidential guidance from professional advisors.

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. 

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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.

We encourage all to apply

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