Associate Director - Medical Writing

A global biotechnology company who are a market leader in their therapeutic area require an Associate Director - Medical Writing to join a high profile team.

You will operate as a subject matter expert and scientific contributor and will be confident working as part of a cross functional team across development and R&D.

You will also take ownership of  developing protocols, creating clinical regulatory documents and regulatory submissions.

You will be passionate about science and operating within an environment of excellence. Our client has a patient focused approach and is dedicated to developing innovative drugs to combat this rare disease and you will play an important part in delivery of their company goals and strategy.

KEY RESPONSIBILITIES:

Preparing and writing clinical study documents and regulatory submissions at all phases including clinical study reports, investigator brochures, responses to HTAs, EMA PIPs, briefing and Agency responses as well as EU orphan drug designation documents.

• Working as a scientific contributor
• Providing a high quality medical writing service 
• Interacting with internal stakeholders and management and providing subject matter guidance
• Document review
• Work in a cross functional team as well as working on SOPs and process improvements

CANDIDATE:

• You will hold a PhD and strong relevant experience working within Biotech and/or Orphan Drugs
• Strong experience in writing and editing clinical regulatory documents
• Ability to analyse data
• People management capability
• Project management skills
• Working collaboratively
• Strong communication skills

Please note that a minimum of 3 days in the office is required

The company pushes continual professional development, offers an excellent benefits package and a modern working environment.  

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.