This Job Vacancy has Expired!

CMC Technical Writer - Pharma/Biotechnology area

Posted on Sep 3, 2019 by Coopers Group GmbH

Basel, Switzerland
Health Care
1 Oct 2019
Annual Salary
Contract/Project

For our pharma client in Basel we are looking for a

CMC Technical Writer (Pharma, CTD, biotechnology experience) - 100%

Tasks and responsibilities:

  • Maintain (author, update and review) Common Technical Documents (CTD) for regulatory submissions, eg CMC changes/variations, post-approval change management protocols and for marketing licensure applications (MAAs/BLAs)
  • Setup and maintain CMC changes in the data base, perform CMC applicant assessments and drive and support the CMC Change Management Process to ensure a continuous and complaint commercial supply
  • Assess suitability of documentation provided by Contract Manufacturer Organizations (CMO) to reflect the information adequately in the registration dossier sections impacted by the change(s).
  • Transfer of external change requests to the client's change management system, preparing the change application in such a way that it is understood by all relevant functions (regulatory, quality, supply chain, etc).
  • Evaluate the impact of the change (GMP and/or regulatory relevant)
  • Ad hoc preparation of answers to questions from health authorities
  • Ensure, product and project timelines, costs and quality are maintained
  • Focus on cGMP production for market supply
  • Help to improve workflows and business processes

Qualifications:

  • 5 to 8 years' experience in international (bio)pharmaceutical industry
  • Degree in Life Science or equivalent (Master or Bachelor)
  • Profound experience in preparation and management of CMC documents, biotechnology expertise preferred
  • Knowledge about CTD structure and content - drug substance (3.2.S) and drug product (3.2.P)
  • Understand ICH guidelines and key regulatory standards
  • Able to effectively manage multiple projects, deadlines and priorities simultaneously
  • Proficient with Microsoft applications
  • Strong interpersonal skills, excellent organizer
  • Fluent in English. German, French and Spanish are an asset
  • Flexibility to adapt to a fast moving and international environment
  • Team player, task oriented and keen on working in a cross-cultural working environment

Start date: 01.10.2019
Duration: 6 - 12 months
Location: Basel

Reference: 752010001

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