CMC Writer
Description:
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: CMC Writer
Location: Paramus, New Jersey, 07652
Job Type: Contract
Duration: 6 Months
Work Type: Hybrid
Job Description:
A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control.
Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
Assess and communicate potential regulatory risks and propose mitigation strategies
Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.
Identify, communicate and escalate potential CMC regulatory issues, as needed
Help establish regulatory CMC submission processes and procedures.
Familiar with eCTD format submission files
Project management skill is plus Key Responsibilities
Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
Process Improvement: Help establish regulatory CMC submission processes and procedures. Requirement
Strong technical writing, analytical, and regulatory knowledge.
In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions, manufacturing processes, analytical methods, specifications, formulation development, test method validation, process validation, and packaging validation.
Familiar with a variety of regulatory guidelines, technical processes, and procedures related to CMC development activities.
Strong planning and organizational skills with demonstrated ability to deliver work on time.
Excellent written and communication skills.
Proficient in the use of Microsoft Office Suite including Word, Excel, Outlook 365 and Access. Qualifications
Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field.
Experience: Prior experience in pharmaceutical or regulatory writing is preferred.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We're founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.