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Job Details

Technical Writer II

Madison, NJ, United States

Posted on
Aug 14,2019

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Project Description:
With supervision, the Individual is responsible for ensuring RA-CMC technical writing objectives are met by
the chemistry, manufacturing, and control (CMC) sections of clinical and marketing application documents. This position will also ensure proper communication with all key partners in the functional departments of Research and Development and Commercial groups in support pharmaceutical development and regulatory filings.
Prepare, coordinate, and manage the chemistry, manufacturing, and control (CMC) documents for annual reports (IND and NDA).
With supervision prepare CMC documents for use in routine US and ex-US regulatory filings.
Provide guidance on use of submission document templates.
Provide assistance on department related assignments and projects.
Identify and communicate routine CMC issues.
Collaborate with diverse functional groups to ensure fileability and acceptance of CMC sections.
Required Skills:
Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline.
2 years of experience in pharmaceutical research and development or regulatory affairs.
1 years of CMC regulatory experience is desirable.
Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions.
Strong working knowledge of manufacturing unit operations.
Superior oral and written communication skills.
Ability to work cooperatively with all levels and types of global personnel required.
Experience working with electronic document management systems.
Ability to work independently under pressure and manage multiple projects simultaneously.
Detail/accuracy oriented.
Collaborative and willing to learn.
Familiarity with US and other international regulatory requirements for drug product dossiers.
This 12 month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kevin:

Location/Region: Madison, NJ

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