Technical writing with labelling & Pharma

Dawar Consulting•Somerville, NJ

About The Position

As a Technical Writer in the Operations Labeling Group at Roche, you will be responsible for creating, revising, and maintaining high -quality labeling documents for medical products. You will ensure all content meets regulatory requirements, global standards, and company guidelines while supporting the timely completion of labeling projects.

Requirements

Bachelor’s degree in Technical Writing, Communications, Life Sciences, or a related field.
Minimum of 3 years of experience as a Technical Writer, preferably in the pharmaceutical, biotechnology, or medical device industry.
Strong knowledge of regulatory requirements and guidelines for medical product labeling (e.g., FDA, EMA).
Excellent writing, editing, and proofreading skills with strong attention to detail.
Proficiency with document management systems and authoring tools (e.g., Adobe Acrobat, Microsoft Office).
Ability to work independently and collaboratively in a team environment.
Effective communication skills with the ability to convey complex information clearly.

Nice To Haves

Experience working with Component Content Management Systems (CCMS).
Familiarity with labeling system software.

Responsibilities

Develop and maintain labeling documents, including Instructions for Use (IFU) and Method Sheets (MS).
Ensure labeling content is accurate, clear, consistent, and compliant with regulatory and company standards.
Review, edit, and proofread labeling documents to ensure quality and compliance.
Collaborate with cross -functional teams to coordinate labeling activities and meet project timelines.
Manage multiple labeling projects simultaneously, ensuring timely completion.