Global Life Science Hub is a leading consultancy that provides Biostatistical, Data Management, and Medical Writing services to clients in the pharmaceutical, biotech, and medical devices industries. With over 90% repeat business, we are committed to delivering high-quality documents to international clients in a timely manner.
We are currently seeking a Director of Medical Writing to lead a team of 4-5 writers. The successful candidate will be responsible for prioritising workload distribution, planning resources, and ensuring the adequate assignment of resources to projects while balancing the workload across the team. Additionally, the candidate will contribute to medical writing, quality control of documents, attend/lead project-related calls and meetings, and maintain comprehensive knowledge of regulatory guidelines and standards in medical writing and clinical research.
Responsibilities:
- Lead the Medical Writing team to deliver high-quality documents such as clinical study reports, clinical study protocols, and development/periodic safety update reports on time.
- Prioritize workload distribution, plan resources, and balance workload across the team.
- Contribute to medical writing and quality control of documents.
- Attend/lead project-related calls, client status calls, and medical writing team meetings.
- Maintain up-to-date knowledge of regulatory guidelines and standards in medical writing and clinical research.
- Recommend and actively contribute to the development and improvement of SOPs and standards.
- Represent medical writing in regulatory inspections and sponsor audits.
- Develop and implement strategies to improve Medical Writing processes and quality.
- Engage with cross-functional teams to facilitate the integration of Medical Writing activities.
Experience/Qualifications:
- Extensive experience in regulatory medical writing in clinical research, particularly protocols and CSR's.
- Proficient in MS Office and document management systems.
- Excellent written and oral English skills.
- Strong medical writing skills and ability to manage teams, timelines, and tasks.
- Strong project management skills, including the ability to prioritize and manage multiple projects simultaneously.
- Strong leadership and people management skills, including the ability to mentor and develop team members.
- Knowledge of ICH guidelines and regulatory requirements for clinical trial documentation.
- Bachelor's or advanced degree in a scientific discipline or equivalent experience.
Apply:
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com
United States
