About Clarity
Clarity Pharmaceuticals is a leading radiopharmaceutical company developing Targeted Copper Theranostics (TCT's) for the treatment of serious diseases. TCT's leverage the perfect pairing of Cu-64 for diagnosis and Cu-67 for therapy. We are currently expanding our team to help facilitate the expansion of programs and are looking for a new team member who is motivated to take on new challenges and excited to help grow the Company.
As a highly skilled Senior Medical Writer you will support our clinical development programs and be responsible for authoring, reviewing, and finalising a wide range of clinical and regulatory documents, ensuring alignment with regulatory requirements and high scientific quality. This role offers the opportunity to work closely with cross-functional teams and contribute to pivotal clinical programs in an innovative and collaborative environment. Hands on experience with FDA NDA submissions, including clinical and non-clinical module preparation is a must. Experience in radiopharmaceutical development is highly advantageous.
About the position
Reporting to the EVP, Clinical Development, the Senior Medical Writer is responsible for creating and supporting the development of a variety of documents including, but not limited to, regulatory related documents, clinical study reports, clinical trial protocols and related documents, presentations, manuscripts, and abstracts. Clear and concise writing as well as adherence to relevant guidelines and regulations are a must.
Duties and Responsibilities
Scientific Documents and Publication Support:
* Collaborate with the clinical teams to interpret clinical data and translate complex scientific information into clear, concise, and accurate documents.
* Synthesise clinical trial results and other scientific data and assist in the preparation of documents such as scientific abstracts, manuscripts, and posters for publication in peer-reviewed journals and presentation at scientific conferences.
* Collaborate with authors/co-authors and relevant internal stakeholders to prepare and submit scientific publications and conference materials.
Regulatory Writing:
* Prepare regulatory documents for submission to health authorities (e.g., FDA, TGA and other global agencies), ensuring they meet the required guidelines and standards.
* Prepare, write and update high-quality, scientifically and medically accurate documents, including, but not limited to, investigator brochures (IBs), Development Safety Update Reports (DSURs), Briefing Books, and other regulatory-related documents (e.g., Investigational New Drug application [IND], New Drug Application [NDA]).
* Ensure that all documentation is compliant with Good Clinical Practice (GCP), Good Documentation Practices (GDP), and relevant regulatory requirements.
* Assist with the preparation of regulatory responses to inquiries and requests for additional information from regulatory agencies.
Clinical Trial Documents:
* Write and revise clinical trial protocols and related documents (e.g. protocol amendments, study synopsis, protocol clarification memos, informed consent forms,) in collaboration with the clinical teams to ensure they are scientifically and medically sound, clear, and compliant with regulatory requirements.
* Contribute to the development of clinical study reports (CSRs) and ensure timely delivery of these documents to support regulatory filings and publication efforts.
Quality Control and Compliance:
* Review and edit documents for scientific and medical accuracy, clarity, and compliance with regulatory guidelines and corporate standards.
* Ensure that all documents are aligned with Clarity's style guide, branding, and communication strategies.
Medical Writing Strategy and Project Management:
* Manage multiple writing projects simultaneously, ensuring that all documents are delivered on time and in accordance with project timelines.
* Provide guidance on medical writing strategy to internal teams, ensuring that the content aligns with overall Company's and scientific goals.
* Support project managers in tracking and reporting the progress of writing tasks, including adjusting timelines and resource allocation as needed.
About you
* Degree in life sciences, medicine, or related field.
* Proven experience in medical writing for regulatory submissions, including protocols, DSURs, IBs, CSRs, and FDA briefing documents.
* Hands-on experience with FDA NDA submissions, including clinical and non-clinical module preparation.
* Experience in radiopharmaceutical development is highly advantageous.
* 3-5+ years of medical writing experience, plus in-depth knowledge of medical writing processes.
* Good knowledge of ICH CGP
* Good operational knowledge of clinical trial reporting and the global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).
* Understanding of biostatistics principles and data management principles for large scale clinical research.
* Strong ability to prioritise and manage multiple demands and projects.
* Ability to build strong relationships and establish rapport within and across teams.
At Clarity Pharmaceuticals we are inspired by our mission to develop next-generation radiopharmaceutical products that improve treatment outcomes for children and adults with cancer. If you are keen to join a company at the forefront of research and innovation, then we look forward to hearing from you.
This role is open to candidates who have full eligibility to live and work in Australia.
For more information or a confidential discussion please reach out to Mary Bennett via