Associate Director, Clinical Regulatory Writing

Introduction to role

Are you ready to lead strategic communications in clinical drug programs? As an Associate Director in Clinical Regulatory Writing, you'll provide leadership and expertise in authoring high-quality clinical-regulatory documents. Your role will be pivotal in ensuring these documents align with project strategies and regulatory requirements, representing the skill on both drug and non-drug projects.

Accountabilities

The Clinical Regulatory Writing team is at the forefront of providing expert communications leadership to drug projects. As an Associate Director, you will manage clinical regulatory writing activities across a portfolio, ensuring that documents meet regulatory, technical, and quality standards. You'll lead submission teams, drive the development of communication strategies, and collaborate with internal and external authoring teams. Your strategic thinking will be crucial in interpreting complex data and delivering clear messages that meet customer information needs. Additionally, you'll support the development of others in the team and drive continuous improvement in communications leadership.

Essential Skills/Experience

• Life Sciences degree in an appropriate discipline.
• Significant medical writing experience in the pharmaceutical industry or CRO.
• Ability to advise and lead communication projects.
• Understand drug development and communication process from development, launch through life cycle management.
• In depth knowledge of the technical and regulatory requirements related to the role.

Desirable Skills/Experience

• Advanced degree in a scientific discipline (Ph.D).

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.