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Job Details

Scientific Writer-146318

Company: PPD
Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Reference: 146318
Closing Date: 20 Sep 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD is a leading global contract research organisation providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organisations. Our Athlone GMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. ...

Requirements:

PPD is a leading global contract research organisation providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organisations. Our Athlone GMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. Our highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.

About the position

PPD are looking for a Scientific Writer to assist in the preparation and review of scientific documents to meet quality standards. Write and edit analytical methods, reports and protocols for potential submission to regulatory authorities.

Key responsibilities

  • Prepare and/or assist in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOP’s, client correspondence and other similar documentation  
  • Compile laboratory data into a specified report format. Ensure that hardcopy and electronic reports are consistent and comply with required formats. Review data tables and listings and ensure that errors are corrected. Perform a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensure compliance with PPD, Client and eCTD policy and procedure on publications.
  • Review scientific documents for accuracy, formatting and consistency and compliance to protocols or SOPs.
  • Work with senior staff to determine approach for new assignments.
  • Keep updated on the guidelines and requirements for the FDA and other international regulatory agencies for reference in the development of required documents.

Qualifications

Education and Experience 

Bachelor's degree or equivalent in science. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:
  • Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts
  • Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable software
  • Working knowledge of industry regulations, GMP, FDA, ICH or other regulated environments
  • Working knowledge of analytical laboratory procedures. Previous experience in a lab environment would be an advantage
  • Effective written and oral communication skills
  • Detail orientated
  • Time management skills
  • Good editorial and proofreading skills
  • Good problem solving and troubleshooting abilities
  • Ability to work well in a collaborative team environment
A distinct PPD culture
 
Founded upon principles of excellence and innovation, PPD shares our clients' passion for delivering life-changing therapies to help people live healthier lives. We are committed to bringing scientific and clinical expertise, quality and speed to every drug discovery and development program to help deliver safe, effective products to the market.


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Apply for this job: Scientific Writer-146318

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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