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Technical Documentation Scientist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Liverpool, Merseyside
  • Sector: Science
  • Date posted: 19/09/2017
  • Job reference: J374234A

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Our client, a contract research company is currently recruiting for an experienced Technical Documentation Scientist (CMC) based at their PSS site in Moreton, UK.

This role is to produce and review the production of Chemistry, Manufacturing and Control (CMC) documentation for investigational and marketing applications of small and large molecules cycle in line with client format to agreed timelines.

The candidate will also have great organizational skills and proven ability to coordinate the assembly of prompt and accurate technical responses to inquiries from the FDA and other regulatory agencies on the CMC sections of regulatory documents and preparation of specification proposals

Job Responsibilities

May include but will not be exclusive to the following and will be based on the applicants' experience and clients' requirements.

  • Author assigned CMC documents, including regulatory documents and small molecule specification proposals.
  • Participate in relevant meetings for the preparation of assigned documents.
  • Provide project assistance to group members to meet IDT/GRS timelines as required, including conducting primary reviews and preparing CMC documents in whole/part on behalf of others.
  • Become proficient in using the client's authoring tools (core template, style guide, CARA3, etc.).
  • Develop understanding and familiarity with relevant SOPs, ICH guidelines, and any additional training required for this role.
  • Maintain Documentation Databases and the project folders on shared drive to include source documents and relevant project information in a timely manner.
  • Document data as dictated by client's current policies and procedures.
  • Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards.
  • To learn and be aware of the customer's requirements and strive to meet or exceed those requirements keeping in mind the customer process end points.
  • To learn to deal with customer queries and contact designated personnel, with appropriate support from onsite leadership, with any relevant information or issues relating to CMC documentation in general.
  • To ensure that the customer's requirements are fully met or exceeded and in so doing will be flexible to work in any area of the business as is required.
  • To have a clear understanding of the customer relationship and service goals.
  • To ensure uniformity, reproducibility, and reliability in all work practices.
  • Once foundational knowledge is in place start to identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.

Experience & Qualifications

  • An MSc or PhD in Pharmaceutics, Organic Chemistry, Biochemistry, or related disciplines would be desirable.
  • 3 to 5 years of pharmaceutical development experience.
  • Ability to quickly learn new processes.
  • Ability to work using fully electronic media, including MS Office and CARA.
  • Ability to communicate clearly, both written and verbally and to form strong working relationships with colleagues.
  • Ability to analyse and interpret complex data from a variety of scientific sources to deliver high quality CMC documentation.
  • Good attention to detail and time management skills.
  • Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them into relevant improvements. Ability to switch priorities at short notice is desired.
  • Good team player, organised, accurate, have strong documentation skills.
  • Passionate about quality and customer service.
  • Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of his/her written and verbal exchanges.
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