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Company

Telix Pharmaceuticals Limited · 8 hours ago

Senior Technical (CMC) Writer

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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Biotechnology

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Responsibilities

Lead the compilation, writing, and editing of high-quality module 3 documents.

Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.

Maintain working knowledge of the Telix development pipeline.

Prepare, review, and edit regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs).

Ensure all documents comply with regulatory guidelines, company standards, and industry best practices.

Lead and manage multiple regulatory technical writing projects simultaneously, ensuring timely delivery of high-quality documents.

Coordinate with cross-functional teams to gather necessary information and resolve any issues that arise during the document development process.

Conduct thorough reviews of documents for accuracy, consistency, and clarity as needed.

Work closely with clinical development teams, including clinical operations, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents.

Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making.

Mentor and train junior medical writers, providing guidance and support to enhance their skills and career development, along with oversight to external contractors.

Stay current with industry trends, guidelines, and best practices, and share knowledge with the team.

Support regulatory submissions by preparing high-quality documentation and addressing health authority comments and queries.

Ensure compliance with regulatory requirements and timelines for all submission-related activities.

Qualification

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Regulatory CMCTechnical WritingProject ManagementDrug DevelopmentSOP DevelopmentDocument TemplatesFDA RegulationsEMA RegulationsICH GuidelinesMentoring

Required

Bachelor’s degree in a scientific or related field required

8+ years’ overall experience in technical/CMC writing

5+ years within Regulatory CMC required

Strong understanding of drug development, drug substance and drug product manufacturing, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles

Experience and proficiency with document templates, document toolbars and proper version control

Strong project management skills

Organized and self-motivated

Strong attention to detail

Preferred

MS or PhD preferred

Experience overseeing and mentoring contractors and junior team members strongly preferred

Benefits

Competitive salaries

Annual performance-based bonuses

An equity-based incentive program

Generous vacation

Paid wellness days

Support for learning and development

Company

Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals.

Founded in 2015

Melbourne, Victoria, AUS

501-1000 employees