Technical Writer, CMC - Biotech - RI

Rhode Island Permanent USD70,000 - USD95,000
  • Craft BLA submission documents within CMC discipline
  • Clinical stage Biopharmaceutical with innovative solutions for rare eye diseases

About Our Client

Our client is a Privately Held small company developing novel therapeutics for degenerative eye diseases. Their cutting edge therapeutic can help patients with serious diseases that would go untreated otherwise. With products in early and late stage clinical development, this client has a strong pipeline of therapies now and into the future.

Job Description

  • Use scientific knowledge and technical writing experience to draft and drive completion of technical documents such as regulatory filing sections (Module 2-CMC and Module 3 of a BLA) and internal technical reports and responses to Agency questions.
  • Collaborate with Manufacturing, Development, Quality, and CMC functional area SMEs in Preparing Development Protocols, Reports, and Technology Transfer Documents.
  • Interpret and summarize complex data into complete technical documents.
  • Alongside the regulatory group and senior management, ensure adherence to the defined regulatory submission schedule for document generation.
  • Responsible for management and authoring of the internal technical and regulatory document review process.
  • Critically review documents for consistency and quality.
  • Promote standardization of document filing preparation process within organization.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Degree in scientific discipline and/or technical writing with at least 4+ years of technical writing industry experience in biotech product development and manufacturing.
  • Experience in preparation of a variety of technical documents such as SOPs, Work Instructions, Qualification Reports, Development Reports, Research Proposals.
  • Experience with Biologic products preferred.
  • Experience with combination products preferred (drug/device or biologic/device).
  • Experience summarizing reports and technical information into regulatory submission sections a must have.
  • Experience in preparation of CMC Sections of Regulatory Documents is preferable.
  • Working knowledge of the ICH and FDA guidelines, GMP and quality compliance requirements.
  • Demonstrated experience in collaborating with diverse cross functional groups.
  • Excellent verbal and writing communication skills effectively interfacing with all levels of management and departments within the company.
  • Ability to handle multiple tasks independently and manage competing priorities.
  • Excellent collaboration skills with focus on timely delivery.
  • Strong organization and analytical skills in order to maintain a high level of productivity, innovation, and a sense of urgency to ensure assignments are completed on-time and on-budget with a high level of quality.
  • Attention to detail to ensure trace-ability of data summary tables accurate to primary source data.
  • Ability to capture succinctly and completely input from technical experts.
  • Self-motivated, assertive, and self-confident with the ability to act with a sense of urgency and passion.
  • Ability to influence decision-making via negotiating, advocating, and being an active listener.
  • Enjoys working in a fast-paced, small-company environment.
  • Resourceful, creative, and results-oriented.
  • Positive

What's on Offer

  • Highly competitive base salary
  • Growth opportunity- extensive opportunity for promotions and a larger role
  • Fast paced position supporting multiple functions
  • Great benefits package
  • Extremely fast-paced, growing environment
Connor Colombo
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Rhode Island
Contract Type
Consultant name
Connor Colombo
Job Reference