Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Skills
Analytical Chemistry
Attention To Detail
Biology
Business Analysis
Business Analytics
CMOS
Chemistry
Collaboration
Communication
Crystal Management Console
Job Details
We are looking for Senior Technical Writer for our client in Morristown, NJ
Job Title: Senior Technical Writer
Job Type: Contract
Job Description:
Pay Range: $54.9hr - $57.9hr
- The technical writer develops and authors Chemistry, Manufacturing, and Controls (CMC) Common Technical Documents (CTD) for development and post-approval regulatory dossiers within set timelines.
- Responsibilities include preparing responses to health authority inquiries, amendments, supplements, variations, and annual reports.
- The technical writer also authors and evaluates change controls for global regulatory impact and may prepare technical reports, position papers, white papers, or SOPs.
- This role requires ensuring regulatory dossier compliance and independently authoring high-quality CMC content while following regulatory guidelines, source documentation, and templates.
- The technical writer collaborates with key stakeholders across business units, contract manufacturing organizations, and functional teams such as Quality, Manufacturing, and Global Regulatory Affairs.
- Additional responsibilities include supporting regulatory risk mitigation strategies, maintaining current regulatory knowledge, and supporting planning and timeline preparation.
- CMC and CTD authoring experience (Modules 2 and 3).
- At least five years of experience in the pharmaceutical industry.
- Experience with document management systems such as Veeva or Documentum (preferred).
- Working knowledge of cGMPs.
- Experience with MS Office applications.
- Excellent interpersonal communication skills.
- Ability to work independently with minimal supervision.
- Strong organization skills, attention to detail, and self-motivation.
- Experience in pharmaceutical manufacturing or quality control/quality assurance (preferred).
- Experience with small molecules and some aseptically manufactured products.
- Medical device experience (preferred).
- Develop and author CMC CTD documents for regulatory submissions.
- Prepare responses to health authority inquiries and regulatory updates.
- Author and evaluate change controls for global regulatory impact.
- Create technical reports, position papers, white papers, or SOPs.
- Ensure regulatory dossier compliance.
- Collaborate with cross-functional stakeholders and CMOs.
- Support regulatory risk mitigation strategies.
- Maintain updated knowledge of SOPs, regulatory guidelines, and ways of working.
- Assist in planning and timeline preparation.
- Ability to work collaboratively across multidisciplinary teams.
- Strong communication and stakeholder coordination skills.
- Expertise in CMC and CTD documentation.
- Knowledge of Veeva or Documentum.
- Understanding of cGMPs.
- Strong organizational and writing skills.
- Ability to analyze and interpret regulatory requirements.
- BS/BA, MS, or PhD in a science or health field such as Biology, Analytical Chemistry, Pharmacy, or a related discipline.
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