Clinical Therapeutics Specialist

1 week ago

Sydney, New South Wales, Australia beBeeTherapeutic Full time $100,000 - $125,000

Overview

Leading pharmaceutical companies are leveraging copper-based theranostics for disease treatment, and a key aspect is the use of Cu-64 for diagnosis and Cu-67 for therapy.

The field of targeted therapeutics is expanding rapidly, with motivated professionals sought after to support clinical development programs in authoring, reviewing, and finalising clinical and regulatory documents.

Essential skills include hands-on experience with FDA NDA submissions, including preparation of clinical and non-clinical modules, as well as adherence to guidelines and regulations.

Additional qualifications such as experience in radiopharmaceutical development can be advantageous.

About the Position

The Senior Medical Writer will report directly to the EVP, Clinical Development, creating and supporting regulatory-related documents, clinical study reports, trial protocols, and related documents.

Responsibilities include scientific document and publication support, with clear and concise writing being essential for success.

  • Scientific Document and Publication Support:

Key aspects of this role involve ensuring that all written content aligns with regulatory requirements and maintains high scientific quality.

Clear communication, strict attention to detail, and flexibility in meeting deadlines are required.

Responsibilities

Key Responsibilities Include:

Scientific Documents and Publication Support:

The role requires effective collaboration with cross-functional teams to create compelling content that meets both internal and external stakeholder needs.

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