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Contract CMC Technical Writer
2 months ago
Description of Role
· Plan, write, proof, edit, and revise state-of-the-art eCTD summary of changes for CMC amendments, Module 2-QoS, and Module 3 documents.
· Plan, write, proof, edit, and revise state-of-the-art technical information and documents, IMPD and summary of changes for CMC amendments.
· Collaborate with CMC and/or CMC Regulatory team members to write and maintain high-quality documentation.
Key responsibilities
· Analyze CMC data and write CMC documents for Health Authorities submissions, including but not limited to IND/BLA/MAA/IMPD, under the guidance of the CMC regulatory strategy lead.
· Collaborate with CMC Regulatory lead to develop writing timelines.
· Edit, proofread and QC the final versions of CMC submission documents (e.g., ensure proper hyperlinking and formatting).
· Convert word format documents into PDF format documents to conform with the submission/regulatory requirements.
· Perform other CMC writing projects as assigned.
Qualifications
· Master’s degree or other advanced degree in science-related field.
· 3+ years of CMC technical writing experience; oncology experience (preferred).
· Experience with writing CMC documents for Global Regulatory submissions, including but not limited to IND/BLA/MAA/IMPD.
· Well-organized: ability to prioritize tasks, to work simultaneously on multiple writing projects, and to complete high-quality documents according to tight timelines.
· Broad knowledge of FDA and EMA/ICH guidelines.
Preferred experience/skills
· Proficiency with Adobe Acrobat, Electronic Common Technical Document (eCTD) templates, SharePoint, and other vendor templates (e.g., Synchrogenix templates).
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com
