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Telixus, also known as Telix Pharmaceuticals, is a dynamic and fast-growing radiopharmaceutical company with its headquarters located in Australia. The company has expanded its reach with additional offices in Belgium, Japan, Switzerland, and the United States. Telix's mission is to advance precision medicine through innovative targeted radiation therapies aimed at enhancing the quality of life for individuals suffering from cancer and rare diseases.
The company is currently seeking a Technical Writer specialized in regulatory affairs within the Quality/Chemistry, Manufacturing, and Controls (CMC) domain. This role presents an exciting opportunity for professionals looking to contribute significantly to Telix's strategic goals, particularly in supporting the international launch of their prostate cancer imaging agent and advancing products in late clinical stages.
The chosen candidate will take on a range of significant responsibilities:
Lead the compilation, writing, and editing of high-quality module 3 documents, ensuring that all submissions are thorough and compliant with necessary guidelines.
Develop and update Standard Operating Procedures (SOPs), processes, templates, style guides, and manuals as appropriate.
Maintain a comprehensive understanding of Telix’s development pipeline.
Prepare, review, and edit vital submission documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Common Technical Documents (CTD).
Ensure compliance with regulatory guidelines and company standards while leading multiple regulatory technical writing projects concurrently, guaranteeing that all documents are delivered on time and uphold high-quality standards.
Work collaboratively with cross-functional teams to gather necessary information and resolve any issues that arise during the document development process.
Conduct thorough reviews to ensure documents' accuracy, consistency, and clarity.
Mentor and train junior medical writers, equipping them with the skills to excel in their roles while providing oversight and guidance to external contractors.
Stay current with regulatory requirements, industry trends, and best practices, sharing this knowledge with the team to foster a culture of continuous improvement.
Candidates applying for this position should possess the following qualifications:
A Bachelor’s degree in a scientific or related field is mandatory; a Master’s or Ph.D. is preferred.
A minimum of 5 years’ experience in technical/CMC writing, with at least 2 years within Regulatory CMC experiences strongly preferred.
Proven ability to manage and mentor contractors and junior team members is an advantage.
A strong understanding of drug development processes, including drug substance and drug product manufacturing, as well as regulations set forth by the CFR, FDA, EMA, and ICH guidelines.
Proficiency in document templates, management toolbars, and proper version control, coupled with excellent project management skills.
Strong attention to detail and organizational skills are essential.
An inclusive mindset, creativity, and an ethical approach to work are highly valued at Telix.
The ideal candidate should embody several crucial attributes:
An inclusive mindset that celebrates diversity and fosters a welcoming environment.
A results-oriented focus that prioritizes achieving goals with measurable outcomes.
Resilience in overcoming challenges and adapting to rapidly changing environments and priorities.
Excellent communication skills to effectively relay information to colleagues and stakeholders at all levels.
A commitment to continuous learning and professional development, always seeking to expand knowledge and skills.
Telix promotes a flexible work environment with options for hybrid and remote working. The company values its employees and offers a competitive salary, supplemented by annual performance-based bonuses, an equity-based incentive program, ample vacation time, paid wellness days, and support for ongoing learning and development.
Telix Pharmaceuticals is an equal opportunity employer, committed to evaluating qualified applicants without regard for race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. They aim to create an ecosystem of diversity and inclusivity within their workforce.
For job seekers interested in contributing to precision medicine and working in a dynamic, supportive environment, this position at Telixus offers a fulfilling opportunity. The combination of cutting-edge work in pharmaceuticals and an inclusive company culture makes this role appealing for qualified technical writers looking to make a tangible impact in the field.
This job offer was originally published on remotive.com
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