Regulatory Document Coordinator

  • location: Chesterfield, MO
  • type: Contract
  • salary: $14.36 - $16.89 per hour
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job description

Regulatory Document Coordinator

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!

 
location: Chesterfield, Missouri
job type: Contract
salary: $14.36 - 16.89 per hour
work hours: 9 to 5
education: Associate
 
responsibilities:
Job Description:

  • 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.
  • 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.
 
qualifications:
Education & Qualifications

  • 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.
  • 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)
 
skills: Laboratory Information Management Systems (LIMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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