Document
Management Systems Manager
A well known branded global pharmaceutical company in
New Jersey seeks a Manager of Document Management Systems.
This position is responsible for the management of all
Document Management systems including Documentum, Integic,
Liquent, and Kofax systems. Also responsible for the
global coordination of change management, which includes
any regional or global system client server changes.
Requirements:
BS or BA
3-4 years experience using Document Management Systems
In depth knowledge and experience with Document Management
applications and software development process. Must
have excellent written and oral communication skills
as this individual will work closely with both users
and customers. This person should have experience with
submissions, requirements, and implementations of CDMS.
This candidate will have 3-4 direct reports.
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QC
Specialist
Job Description
A well known branded pharmaceutical company in New Jersey
seeks QC specialist to be responsible for quality control
of all documents written in medical writing (protocols,
amendments, investigator brochures, and clinical study
reports).
Perform accurate, precise proof-reading, including spelling,
grammar and punctuation.
Ensure all company's documents are of the highest quality
possible.
Qualifications
Bachelors degree required
2-3 years experience in the pharmaceutical industry
Working knowledge of ICH E3 and AMA style guidelines
Experienced in regulatory documents
Basic understanding of medical terminology
Strong attention to detail
Able to work well in a team environment and function
under tight deadlines
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Document
Specialist, Early Drug Development
A pharmaceutical Company in New Jersey seeks a Document
Specialist, Early Drug Development to be responsible
for the following:
1. Manage document and word processing support of GLP
and non-GLP nonclinical studies conducted for Non-Clinical
Development with Contract Research Organizations and
internal labs in the areas of Toxicology, Drug Metabolism
and Pharmacokinetics.
2. Communicate changes in reports to authors, including
CRO personnel in an effective manner.
3. Track reports through review cycle and maintain
internal report tracking system.
4. Provide document and word processing support in
the preparation of nonclinical submission documents
including, INDs, NDAs, CTD, IBs and CTAs for submission
to health authorities.
5. Work with Regulatory Operations department to initiate
and maintain Early Drug Development electronic study
report repository, and manage 1). Authoring, review
and approval process of electronic documents and 2).
Review and approval process of contracted study reports.
6. Supports Early Drug Development personnel as needed
for report management.
7. Ensure all documents are maintained according to
departmental SOP.
8. Assist in the development of departmental forms
and procedures.
Skills/Knowledge Required:
College degree or equivalent industry experience required;
minimum 2-5 years experience desired
Prior Non-Clinical and Clinical Pharmacology experience
preferred
Documentum or eSubmission experience preferred. Quality
experience a plus.
Good working knowledge of drug approval process
Strong PC experience, Microsoft Office Suite experience
required including Microsoft Word; Excel; Outlook; PowerPoint
and strong computer acumen.
Must be flexible and adaptable to changing project priorities
and work assignments
Candidate should demonstrate creative thinking as it
relates to identifying and recommending solutions to
problems
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