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.
Requirements
Minimum required: Bachelor’s degree in a pharmaceutical based field or related sciences, engineering, technology, or equivalent.
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
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.
Benefits
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.