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Technical Writer

Role overview

Qualifications

  • Bachelor’s degree in medical laboratory sciences, biology, chemistry, or another relevant scientific discipline required.
  • Minimum of two (2) years of scientific or technical writing experience strongly preferred.
  • Knowledge of Good Documentation Practices (GDP) and regulated environments, including CLIA, CAP, and GLP preferred.
  • Demonstrated excellence in technical writing, grammar, editing, and document review.

Responsibilities

  • Develop, review, and maintain controlled documentation that supports validation and laboratory operation activities.
  • Collaborate with cross-functional subject matter experts to manage documents and support quality initiatives.
  • Write and edit forms, protocols, reports, and procedures from existing templates under supervision.
  • Participate in additional projects such as process improvement initiatives and training.

Key facts

Other skills

  • Quality Assurance
  • Collaboration
  • Mentorship
  • Detail Oriented
  • Critical Thinking
  • Organizational Skills
  • Time Management

About the company

Eurofins BioPharma Product Testing Ireland Ltd logo

Eurofins BioPharma Product Testing Ireland Ltd

Contract Research Organizations (CRO)

Eurofins is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies. Its parent company, Eurofins Scientific, employs over 55,000 people in over 900 laboratories across 50 countries in Europe, North and South America and Asia-Pacific. In total the company offers a portfolio if over 200,000 analytical methods. We are rapidly expanding our fast-paced laboratory based in Dungarvan, County Waterford where currently employ over 500+ people. We have a similar number of employees based at client sites in Ireland and the UK through our successful and award-winning Professional Scientific Services programme. Our facilities are state-of-the-art and our broad base of clients means we work on a diverse range of products and development projects. People are at the heart of our business – both in terms of those we serve (patients and clients throughout the world) and our employees who work tirelessly to contribute to global health and safety. The work we do make a difference and we encourage everyone to play their part.

Company details

Company typeSME
IndustryContract Research Organizations (CRO)
Company size201 - 500

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Job description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

    Job Description

    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:

    • 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 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 - 5:00pmadditional 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.

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    Marcus Rivera

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    m.rivera@company.com
    linkedin.com/in/marcusrivera
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