Technical Writer

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

Qualifications :

Basic Minimum Education Qualifications:

• Bachelors 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

• Minimum of two (2) years of scientific or technical writing experience strongly preferred.
  • 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

• Minimum of 6 years of experience in a dedicated Technical Writing role.
  • 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:

• Demonstrated excellence in technical writing grammar editing and document review.
• Strong organizational skills with the capacity to manage multiple priorities simultaneously while maintaining accuracy and consistently meeting client deadlines.
• Strong attention to detail critical thinking and analytical skills with a commitment to producing high-quality error-free work.
• Ability to collaborate effectively with cross-functional teams including subject matter experts laboratory operations project management quality personnel and external clients to develop revise and maintain compliant documentation.
• Ability to work efficiently and independently with little or no supervision

Physical Requirements:

• Physical dexterity sufficient to use hands arms and shoulders repetitively to operate a keyboard and other office equipment use a telephone access file cabinets and other items stored at various levels including overhead
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance over the telephone and in a group setting
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
• Mental acuity sufficient to collect and interpret data evaluate reason define problems establish facts draw valid conclusions make valid judgments and decisions

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information :

Position is full-time working Monday - Friday 8:00am - 5:00pm additional hours as needed. Candidates currently living within a commutable distance of Lenexa KS are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Yes

Employment Type :

Full-time