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Position announcement
Senior Documentation Specialist- 720-2
We are looking for an individual who will directly interface with members
of the Vertex drug development
teams to manage the collection and protection of original scientific and
regulatory documents critical to the
success of FDA submissions.
This individual will assure document standards are met prior to archiving
and maintains the historical file.
They will Maintain the database for orderly retrieval of documents, and
assure the quality of documents by
assisting in auditing of records prior to submission to FDA. These
sensitive and confidential original
documents include preclinical pharmacology and toxicology study reports,
patient consent forms, case report
forms, study blinding information, technical reports on clinical trials,
product batch records, stability data,
extensive clinical regulatory documents, frequent correspondence records,
and IND applications.
This individual will also contribute to the continuous improvement of
document control systems, and assists
the QA staff by performing other QA and Regulatory duties as needed.
Assist in preparing regulatory
submissions.
Responsibilities include:
* Responsible for the maintenance of the restricted access central data
vault and the supervision of the
Documentation Specialist. Assure the quality of the data and records
prior to archiving by assessing
completeness, legibility, and fitness of documents.
* Responsible for control of documents being prepared for regulatory
submissions. This includes formatting,
proofing, indexing, and filing. Track and control original documents to
support future regulatory filings
necessary to fulfill FDA license applications. Ensure a rapid retrieval
of documents for Agency inspections.
*Assure completeness, quality, security and efficient retrieval of all
documents and copies issued to
authorized individuals. Provide assistance to product development teams
to retrieve information. Review
document change requests for completeness and coordinate approval.
Maintain the distribution file, and
assure appropriate communication of changes is performed. Interaction
with scientists and clinical staff is
frequent and may involve assisting in resolving differences.
Education Requirements: BS degree, preferably in basic or applied science
and skills in composition, and
editing of expository technical documents. A general knowledge of common
PC word-processing programs
and Excel spreadsheets. Disciplined work habits and the ability to
organize files, cross reference
documents, and establish searchable indexes for files.
Experience/Qualifications: Five to seven years practical administrative
experience with emphasis in
document processing and control. Knowledge of computer systems,
preferably in Macintosh based
documentation systems. Expertise in word processing and experience with
desktop publishing and
Documentum ? (electronic document management system) is a plus.
Experience in a biotechnology or pharmaceutical regulated environment is
a critical. Strong interpersonal
skills and the ability to interact with scientists and clinical staff is
vital. Problem solving skills are required to
correct discrepancies and to resolve differences of opinions in document
change requests.
You may apply for this position in one of the following ways:
Submit your resume directly via the web (preferred method) at
http://www.vpharm.com/
Mail to:
Recruiting - Dept. W
Vertex Pharmaceuticals Incorporated
130 Waverly Street
Cambridge, MA 02139
Fax: +1 617 577 6645
If you mail or fax your resume, please specify the position in which you
are interested.
Vertex Pharmaceuticals Inc., is an EQUAL OPPORTUNITY EMPLOYER.
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