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We're looking for a Technical Writer III
, working in Pharmaceuticals and Medical Products
industry in Cambridge, Massachusetts, 02142, United States
- Prepare and review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.
- Support Process Owners in the development and streamlining of content, including processing mapping and RACI tables.
- Work with subject matter experts and key functional department personnel to ensure timely development and accurate content of required documentation. Recommend revisions or changes in scope, formatting, and content as identified.
- Perform Quality Control reviews on process document content and formatting.
- Maintain and coordinate activities related to the document creation using the EDMS including document initiation, workflow support, revision, and retirement.
- Monitor shared mailboxes for documentation related requests; engage wider team for support in responding to non-documentation requests, as required.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- BS/BA degree or equivalent required
- Minimum of 5 years of experience writing controlled documentation in the biotechnology or pharmaceutical industry
- Direct experience in GXP-compliant quality systems is preferred
- Knowledgeable in FDA regulations
- Experienced in Microsoft office applications specifically Word, Excel and Visio
- Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes
- Excellent communication skills including: technical writing, interpersonal and collaborative skills
- Excellent organization skills with the ability to stay accountable to deliverables and milestones
- Ability to thrive and multi-task in a steady-paced environment
- Must have in-depth knowledge and understanding GXP regulations, and controlled document management principles
- Must work effectively in a team environment and with individuals at all levels within an organization
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?