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Document Coordinator


  • Unicon Pharma
  • 09/13/20
  • Saint Louis, MO
  • 63198
  • 15.00 / Hourly
  • Contractor
Job Description:
Location: Chesterfield MO
Duration: 36-39 Months
Summary:
Regulatory document coordinator duties include supporting regulatory dossier authoring, managing document reviews, ensuring that document complies with internal standard and regulatory requirements, data verification (auditing), document reviews to gather relevant information, managing multiple document completion timelines.
Light technical writing and editing expected, applied to regulatory documents and supportive technical reports. Attention to detail particularly for verification of data integrity is crucial.
The colleague must work within established corporate and organizational guidelines and must record and document all relevant information.
The colleague must be able to thrive in a fast-paced environment and to interact effectively with peers and senior scientists & engineers as part of a multi-disciplinary team.

Responsibilities:
Individual will work with scientists and engineers in support of technical report and regulatory document authoring, editing, and auditing. Individual will consult with scientists/engineers and project leads for scope of work but is expected to work independently most of the time.
Light technical authoring
Document editing and formatting to meet corporate and regulatory submission format requirements
Auditing (verifying) of data and information against source documents and data systems for completeness and accuracy.
Seek guidance in resolving conflicting priorities and timelines. Apply judgment in problem solving with guidance from technical project leads.

Skills:
Attention to detail, strong organizational skills, a customer focused approach, the ability to multitask, and effective interpersonal and communication skills are required.
Extremely facile with Microsoft Word including advanced editing features and formatting.
Facile with other routine Microsoft Office and similar applications in use in corporate office environment.
Familiarity with Documentum based knowledge management and document repository systems (electronic document management systems) is preferred.
Familiarity with electronic lab notebook and Laboratory Information Management Systems (LIMS) systems and concepts is desirable.
Demonstrates rigorous attention to detail, excellent written English scientific writing skills (biological/chemical/pharmaceutical technical writing skills preferred, writing samples will be requested)

Education and Experience:
Expect Bachelors degree or similar college / university education, preferred in scientific / engineering discipline (eg. biological, chemical, pharmaceutical) or technical writing background.
Prefer 2+ years of work experience, ideally in a technical writing or knowledge management role, or in a scientific/engineering role with emphasis on writing and documentation.
Demonstrated attention to detail. Will require modest writing samples for evaluation.
Experience working in a regulated industry is preferred. Familiarity with GxP (especially GMPs) preferred.


Employer Information

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