Medical Writer

1 week ago

Melbourne, Australia TQSolutions Full time

About our business

Accelagen is a leading, full-service Pharmaceutical and Medical Device Development Organisation.

The Accelagen team is comprised of clinical specialists who provide wide ranging services and support in the development and implementation of clinical trials, for both local and international clients.

The Biometrics unit is growing at a fast rate and offers high quality statistical and data management services for our clients, while exhibiting a standard of professionalism and dedication that exceeds our clients' expectations. We are looking for a Medical Writer to compliment these services.

About the role

Reporting to the Head of Biometrics, you will contribute all aspects of medical writing in this innovative and hands-on role. Key responsibilities of the role include but are not limited to:
Coordination of clinical project document writing

Writing of Clinical Study Protocols, Clinical Study Reports and Investigators Brochures, but also more technical documents like PSUR, DSUR, etc. based on international standards and templates.

Quality control activities of regulatory documents

Synthesize and integrate comments from both internal and external clients into documents

Manage life-cycle of documents from draft through development, to finalization

Developing training materials and conduct training for colleagues

About You

To be successful in the role you will have a minimum of 3 years’ experience in clinical trial regulatory writing, with a sufficient understanding of the clinical trial environment (GCP) as well as sufficient understanding of listings, tables and figures. You will be tertiary qualified within life sciences, pharmacy, or another related technical qualification. You have strong attention to detail and enjoy problem solving, with a high level of written and verbal communication. You are self-driven, resourceful and understand the importance of continuous improvement and life-long learning.

You may currently be in a Medical Writing role looking for a role where you can continue to utilise and develop your skills.

This position is onshore in Australia, and is home or Melbourne office based.

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