Following:

BioPharma Technical Writer IWrite 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 assignedBioPharma Technical Writer IIAs 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

QualificationsBasic 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 IMinimum 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 IIMinimum 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 overheadAbility 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 settingAbility 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 decisionsThe 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 InformationPosition 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.

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