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CMC Technical Writer |
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Job Category:
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Technical/Medical Writers |
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Job description:
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Currently, one of our clients in Collegeville, PA is seeking a CMC Writer to join their team immediately, for an exciting 11-month assignment.
The candidate will be expected to effectively perform the following functions: (1) Author Chemistry Manufacturing and Controls (CMC) information for post-approval changes made to approved regulatory submissions for marketed products. (2) Revise and redact CMC submissions for filing in Asia-Pacific and Latin American regions. (3) Ensure CMC information is complete, accurate, in proper Common Technical Document format, and complies with applicable regulatory requirements. (4) Interface directly with CMC Strategists, external suppliers, technical representatives and Quality personnel to obtain source documentation and facilitate the development, review, approval and submission of high quality CMC information to regulatory agencies. (5) Provide technical and regulatory review of information provided in support of development of CMC information. (6) Plan and facilitate formal meetings and teleconferences with customers. (7) Review documentation from departments outside Regulatory Affairs for manufacturing changes, and incorporate into CMC submissions in e-CTD format as Submission Ready Components.
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Skills:
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Candidate should have at least 4 years of CMC writing experience. Highly organized, attentive to detail, able to work effectively with internal and external customers, excellent technical writing skills.
Academic Experience is NOT a Substitute for Industry Experience
keywords: CMC, technical writing, regulatory, CTD, manufacturing, pharmaceutical, biotech, collegeville, PA, MedFocus
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Bachelors |
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Experience (year):
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5 |
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Job Location:
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Collegeville - PA - USA |
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Post Date:
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11/17/2008 |
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