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Company

PL Developments

Address , Miami, 33172, Fl
Employment type FULL_TIME
Salary
Expires 2023-07-26
Posted at 11 months ago
Job Description
Job Details

Description

*Please note that this position is subject to PL Development's mandatory COVID-19 vaccine policy.*


JOB QUALIFICATIONS:

  • Planning and organization skills; and ability to manage multiple projects in parallel
  • Excellent written and verbal communication skills, and interpersonal skills.
  • Associate Degree in writing or a technical field with minimum of two (2) years of experience on similar job or Bachelor’s Degree in science from an accredited college or university
  • Experience working in a Pharmaceutical, Medical Devices or regulated industry
  • Demonstrated ability to work well in a fast-paced setting with excellent organizational skills.
  • Computer proficiency: Word, Excel and Power Point
  • Strong attention to detail
  • Experience with or able to quickly learn document management software
  • Able to read and understand technical and regulatory literature
  • Knowledgeable in cGMP’s and FDA regulations

POSITION RESPONSIBILITIES:

  • Other duties may be assigned as deemed appropriate by management.
  • Organizes data and drafts protocols, methods and reports
  • Prepares and optimizes templates to improve efficiency and ensure continuity of style and content for documents
  • Track overdue documents, and support document owners on creating the CRNs and facilitate their approval
  • Draft minor deviations and investigations as required
  • Obtains necessary approvals for all types of documents
  • Converts vendor and customer documents (specifications, methods, etc.) into company format
  • Executes method transfer, verification and validation protocols
  • Works with document owner to make appropriate revisions

PHYSICAL REQUIREMENTS:

  • Complies with all Company policies and procedures, including safety rules and regulations
  • Work is performed in a standard office environment
  • Employees are required to wear eye protection and lab coats while in the lab
  • Subject to standing, walking, bending, reaching, stooping, and lifting of objects up to 25 pounds

Qualifications

Education

Required

Associates or better in Professional Writing or related field.

Experience

Required

8 years: Experience working in a Pharmaceutical, Medical Devices or regulated industry
2 years: Associate Degree in Writing or a Technical Field