• Sr. Technical Writing Specialist

    ThermoFisher Scientific (Durham, NC)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Office

    Job Description

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

     

    Excellent Benefits Package

     

    Review our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)

     

    Medical, Dental, & Vision benefits-effective Day 1

     

    Paid Time Off & Holidays

     

    401K Company Match up to 6%

     

    Tuition Reimbursement – eligible after 90 days!

     

    Employee Referral Bonus

     

    Employee Discount Program

     

    Recognition Program

     

    Charitable Gift Matching

     

    Company Paid Parental Leave

     

    Career Advancement Opportunities

     

    As a Senior Technical Writing Specialist, you will apply your outstanding writing skills and understanding of GxP to lead the development, editing, and improvement of Global policies and procedures. You will be tasked with working with documents with a focus on accuracy and adherence to define timelines. Your role will involve collaboration with subject matter experts and leaders to produce concise, valuable GMP content. You have a passion for creating clear, relevant documentation that is practical and beneficial for users across our organization. Additionally, you will assist and guide in addressing regulatory observations, ensuring compliance and driving continuous improvement.

    Key Responsibilities

    + Apply expert writing and editing skills to produce global documents, including policies, manuals, procedures, and work instructions, which are critical to our worldwide operations.

    + Support and lead regulatory response activities, including technical writing and response management, to ensure timely and accurate submissions.

    + Advocate for clarity and consistency in written content, redrafting material provided by others and assisting colleagues in articulating their ideas effectively.

    + Proofread and edit content from various contributors to ensure completeness, accuracy, and clarity.

    + Participate in team meetings with business unit representatives, managers, subject matter experts, quality and regulatory to discuss document requirements.

    + Lead and facilitate decision-making processes related to key document development activities.

    + Set and maintain high standards for instructional writing, ensuring accuracy and precision.

    + Manage graphics, support style guidance, translations, and document control aspects as required.

    + Train, mentor, and coach other writers to enhance document quality and interpersonal skills.

    + Stay updated with GxP standards and industry best practices.

     

    How will you get here?

    Education

    Minimum required: Bachelor’s degree in a pharmaceutical based field or related sciences, engineering, technology, or equivalent.

    Experience

    + 8+ years of technical writing experience in pharma or regulated industry.

    + Shown experience in writing policies, procedures, and other documents with global impact.

    + Experience in using a Document Management System such as Documentum D2

    Knowledge, Skills, Abilities

    + Strong verbal and written communication capabilities enabling both independent work and effective collaboration within teams.

    + Proficient in organizing information logically and writing clearly, concisely, accurately, and efficiently.

    + Comprehensive knowledge of GxP pharmaceutical guidelines, including the capability to adjust content structure, tone, and style to suit specific requirements.

    + Strong interpersonal, project management, and critical thinking skills.

    + Skilled in learning new processes and software tools, with keen attention to detail.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.