Director, Clinical Regulatory Writing — Submissions Leader

AstraZeneca; Cambridge; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading global biopharmaceutical company in Cambridge is looking for a Director of Clinical Regulatory Writing. This role involves driving communication strategies for drug projects and ensuring successful submissions. Candidates should have a Master's or Ph.D. in a scientific discipline and experience in clinical regulatory writing, especially in oncology. The position requires strong leadership and stakeholder management skills, and offers a competitive salary with flexible working conditions.

Qualifications

• Minimum Master's degree in a scientific discipline; PhD is strongly preferred.
• Thorough understanding of oncology drug development and knowledge of oncology endpoints.
• Ability to effectively communicate with stakeholders.

Responsibilities

• Provide expert leadership across a group of submissions or programs.
• Drive information sharing across program and submission teams.
• Influence stakeholders to establish best communications practices.

Skills

Clinical interpretation skills

Stakeholder management skills

Proficiency at authoring/editing clinical regulatory documents

Oncology drug development knowledge

Program management experience

Education

Master's degree in Scientific discipline

Ph.D. in Scientific discipline

Job description

A leading global biopharmaceutical company in Cambridge is looking for a Director of Clinical Regulatory Writing. This role involves driving communication strategies for drug projects and ensuring successful submissions. Candidates should have a Master's or Ph.D. in a scientific discipline and experience in clinical regulatory writing, especially in oncology. The position requires strong leadership and stakeholder management skills, and offers a competitive salary with flexible working conditions.