Contract Medical Writer Boston

Investigo are working with a biotech in Boston who are looking for a Regulatory Medical Writer (contract) to join the expanding team. You will be responsible for writing all core regulatory submissions.

Duties and Responsibilities

• You will be the Regulatory 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
• 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 develop timelines for the completion 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 working as a Regulatory Medical Writer
• Experience of working within biologics

Benefits

• Immediate start
• Contract for 6 months, 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 Lizzie Kennedy at Investigo on 646-887-9267 or email lizzie.kennedy@investigo-us.com