Technical Writer

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

We are seeking a highly skilled and detail-oriented Technical Writer to join our team. The successful candidate will be responsible for creating, reviewing, and managing a variety of technical documents that support our drug development, regulatory submissions, and compliance efforts. This role requires a strong understanding of pharmaceutical processes, regulatory requirements, and the ability to translate complex scientific information into clear, accurate, and compliant documentation.

Please note that this role is not eligible for agency recruiting support.

Job Requirements

• Develop, write, and edit technical documents including Standard Operating Procedures (SOPs), clinical study reports, regulatory submissions (e.g., INDs, NDAs, BLAs), investigator brochures, protocols, and other technical documents.
• Ensure all documentation is accurate, clear, concise, and adheres to both industry standards and regulatory requirements.
• Act as a primary point of contact for documentation support between Quality Assurance and other departments as needed, ensuring clear communication and understanding of documentation requirements.
• Work closely with subject matter experts (SMEs) to gather and validate technical information, ensuring the accuracy and relevance of content.
• Partner with Regulatory Affairs to understand submission timelines and requirements, and ensure all documents are prepared and submitted accordingly.
• Coordinate with Document Control and Quality Assurance to incorporate feedback and ensure all documents meet internal and external quality standards.
• Assist in training new team members and other staff on documentation processes and standards.
• Provide ongoing support and guidance to team members and other departments regarding best practices in technical writing and document management.
• Develop and maintain templates, style guides, and other resources to support consistent and efficient document creation across the organization.
• Organize and lead document review meetings, incorporating feedback from various stakeholders and ensuring consensus on final documents.
• Contribute to the development of documentation plans and schedules, aligning with overall project timelines and milestones.

Education & Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Technical Writing, or a related field.
• Advanced degree (e.g., Master's, Ph.D.) preferred.
• Minimum of 3-5 years of technical writing experience in the pharmaceutical or biotechnology industry.
• Experience with regulatory submissions and knowledge of regulatory guidelines (e.g., FDA, EMA, ICH) are highly desirable.

Knowledge, Skills & Abilities

• Excellent written and verbal communication skills.
• Strong attention to detail and ability to produce high-quality documentation.
• Proficiency in Microsoft Office Suite and document management systems.
• Ability to work independently and manage multiple projects simultaneously.
• Strong organizational and time-management skills.
• Ability to work collaboratively in a team-oriented environment.
• Ability to adapt to changing priorities and work under pressure to meet deadlines.
• Proficiency in using multiple electronic software applications required to perform duties (MS Word, MS Excel, MS PowerPoint, Monday.com, SAP, Blue Mountain)

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annual medical plan deductible And that’s just the beginning.

Do you share our vision?

Applications are currently being accepted through the Neurotech Career Center.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Please note, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.