Regulatory CMC Dossier Writer - Boston

Posted 26 November 2019
Salary Up to £0.00 per annum
Location
Job type Permanent
ReferenceBBBH96606_1574797524
Contact NameCharlie Seelinger

Job description

Investigo are working with a large biotech company in Boston who are looking for a Regulatory CMC Dossier Writer (contract) to join the expanding team. You will be responsible for writing all core CMC submissions as well as CMC sections of regulatory documents - this will all be within the biologics space.

Duties and Responsibilities

  • You will be the Regulatory CMC lead for an oncology product to support NDA/MAA dossier and global registration planning
  • You will be responsible for coordinating the assembly of prompt and accurate technical responses to inquiries from the FDA and other regulatory agencies on the CMC sections of regulatory documents
  • You will be responsible for planning and conducting FDA meetings
  • You will work with all stakeholders to map out an effective registration package
  • You must possess strong collaboration skills and be able to work across stakeholder groups and departments
  • You will head up the CMC documentation group and provide feedback to the Integrated Development Team on CMC issues
  • You will develop timelines for the completion of the CMC sections of regulatory documents
  • You must have an excellent eye for detail
  • You will be responsible for analysing data and imparting your knowledge of fundamental principles in pharmaceutical sciences

Experience

  • You must have a BS/MS in a Scientific discipline
  • You will have 5+ years' experience in relevant Pharmaceutical industry and role
  • Hands on CMC experience
  • Experience of working within biologics

Benefits

  • Immediate start - although our client is willing to wait for the right candidate
  • Contract until the end of the calendar year, although this is likely to be extended
  • Competitive daily rate
  • Global opportunity - you will get the chance to collaborate with stakeholders globally and expand your reach and knowledge

For more information on this role or any others throughout the US, then please reach out to Charlie Seelinger at Investigo on 516-724-7591 or email charlie.seelinger@investigo-us.com