OverviewClarity Pharmaceuticals is a leading radiopharmaceutical company developing Targeted Copper Theranostics (TCTs) for the treatment of serious diseases.
TCTs leverage Cu-64 for diagnosis and Cu-67 for therapy.
We are expanding our team and seek a motivated Senior Medical Writer to support clinical development programs, authoring, reviewing, and finalising a wide range of clinical and regulatory documents with regulatory alignment and high scientific quality.
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 creates and supports regulatory-related documents, clinical study reports, clinical trial protocols and related documents, presentations, manuscripts, and abstracts.
Clear and concise writing and adherence to guidelines and regulations are essential.ResponsibilitiesScientific Documents and Publication Support: Collaborate with 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; assist in preparing abstracts, manuscripts, and posters for publication and conference presentations.Collaborate with authors and 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 guidelines and standards.Prepare, write, and update high-quality, scientifically and medically accurate documents, including IBs, DSURs, Briefing Books, and other regulatory documents (e.g., IND, NDA).
Ensure documentation is compliant with Good Clinical Practice (GCP), Good Documentation Practices (GDP), and relevant regulatory requirements.Assist with regulatory responses to inquiries 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) with clinical teams to ensure scientific accuracy and regulatory compliance.Contribute to the development of clinical study reports (CSRs) and ensure timely delivery to support regulatory filings and publication efforts.Quality Control and Compliance: Review and edit documents for scientific and medical accuracy, clarity, and regulatory compliance.Ensure documents align with Clarity's style guide, branding, and communication strategies.Medical Writing Strategy and Project Management: Manage multiple writing projects, ensuring on-time delivery and alignment with project timelines.Provide strategic guidance to internal teams to align content with company and scientific goals.Support project managers in tracking and reporting writing progress, adjusting timelines and resources as needed.About youDegree in life sciences, medicine, or related field.Proven experience in medical writing for regulatory submissions (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 and knowledge of medical writing processes.Good knowledge of ICH CGP.Strong understanding of the global regulatory environment and clinical trial reporting.Understanding of biostatistics principles and data management for large-scale clinical research.Strong ability to prioritise and manage multiple demands and projects.Ability to build strong cross-functional relationships.This role is open to candidates with full eligibility to live and work in Australia.
For more information or a confidential discussion please reach out to Mary Bennett via ****** location: Sydney, New South Wales, Australia.We are inspired by our mission to develop next-generation radiopharmaceutical products that improve treatment outcomes for children and adults with cancer.
We look forward to hearing from you.
#J-18808-Ljbffr