CMC Technical Writer

Currently, one of our clients in Collegeville, PA is looking for a Chemistry Manufacturing and Controls Technical Writer to join their team immediately.

Candidate will be responsible for the authoring of Chemistry Manufacturing and Controls information for post-approval changes made to approved regulatory submissions for marketed products. Candidate will ensure regulatory submissions for post-approval changes are complete, in proper Common Technical Document format, and comply with applicable regulatory requirements. This individual will interface directly with CMC Strategists, external suppliers, technical representatives and Quality personnel to obtain source documentation and facilitate the development, review and submission of high quality CMC information for submission to regulatory agencies. Candidate will provide technical and regulatory review of information provided in support of development of CMC information and will review documentation from departments outside Regulatory Affairs for manufacturing changes, and incorporate into CMC submissions in e-CTD format as Submission Ready Components.

MedFocus is a respected provider of scientific and clinical personnel to the leading pharmaceutical and biotech companies across the U.S. We provide competitive salary and benefit packages along with the chance to work with the most sought after companies in the industry. Visit us at www.medfocus.com to explore the opportunities that we currently have available.
REQUIREMENTS
Education/Experience:
BS/MS in science, pharmacy, engineering, or equivalent with 3 years of technical writing experience and previous experience authoring CMC information.