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Telix Pharmaceuticals is a rapidly expanding global company in the field of radiopharmaceuticals, with its headquarters in Australia and offices across Belgium, Japan, Switzerland, and the USA. The company's mission revolves around delivering solutions in precision medicine, specifically focusing on enhancing the quality of life for individuals affected by cancer and rare diseases. In this role, the successful candidate will play a pivotal part in supporting the international launch of a prostate cancer imaging agent, contributing to a portfolio of clinical-stage products that address significant unmet medical needs in oncology.
The position available is that of a Medical Writer. This role is integral to achieving Telix's strategic goals by leading and managing the writing process for various critical documents necessary for clinical drug development. The Medical Writer will be tasked with preparing comprehensive clinical and regulatory documents, ensuring that the information is accurate, well-organized, and adheres to industry standards.
The primary responsibilities of the Medical Writer include:
Leading the compilation, writing, and editing of high-quality regulatory documents such as clinical study reports (CSRs), Investigator Brochures (IBs), safety narratives, and more, primarily directed toward clinical applications.
Organizing, analyzing, and interpreting scientific and statistical data to support the writing process. This involves drawing scientific conclusions, solving problems, and composing text that effectively conveys critical information.
Collaborating with a multidisciplinary team that includes colleagues, physicians, clinical scientists, and statisticians, ensuring that all projects meet timelines and quality standards.
Responding to queries from health authorities and collaborating with project teams to ensure comprehensive responses.
Maintaining updated knowledge regarding the clinical development pipeline at Telix and developing necessary Standard Operating Procedures (SOPs) and style guides to facilitate consistent quality.
Candidates interested in this role must possess a strong set of skills and qualifications, including:
A Bachelor of Science or a related field is mandatory, while an advanced degree is preferred.
A minimum of 5 years of experience in regulatory medical writing or a similar domain is required, ensuring familiarity with regulatory frameworks and document types.
Proficiency in understanding drug development, clinical study design, and various regulations (such as CFR, FDA, EMA, and ICH guidelines) is crucial.
Demonstrated experience with the writing of essential documents like clinical protocols, eCTD summaries, and integrated summaries of safety and efficacy.
Strong proficiency in Microsoft Word and a solid command of the English language, with the ability to present clinical data clearly and persuasively.
Excellent communication skills, coupled with a collaborative spirit, are essential for team-oriented work within the company’s culture, emphasizing inclusiveness and motivation.
Successful applicants should also exhibit several key capabilities:
A commitment to fostering an inclusive workplace, where diversity is appreciated and everyone feels valued.
A penchant for creativity and innovation, allowing for unique problem-solving approaches.
A results-oriented mindset, consistently striving to meet goals and objectives.
Adaptability in a changing environment, ready to tackle new challenges and take initiative.
Strong interpersonal skills, who can comfortably engage with stakeholders at all organizational levels.
Demonstrated project management skills, organized and self-motivated with an acute attention to detail.
Working at Telix Pharmaceuticals means being part of a supportive and engaged team. Employees benefit from a hybrid and remote work culture, reflecting the company's adaptability in various market conditions. The company values its employees and promotes professional development through various learning opportunities.
Although specific salary details are not disclosed, Telix Pharmaceuticals offers competitive salaries and benefits, which typically include:
Annual performance-based bonuses.
An equity-based incentive program.
Generous vacation days and paid wellness days.
Support for continuous learning and development opportunities.
Telix Pharmaceuticals is proud to be an equal opportunity employer, reflecting a commitment to diversity in the workplace. They evaluate qualified applicants without discrimination based on race, religion, gender identity, disability, or any other legally protected characteristic.
This Medical Writer position at Telix Pharmaceuticals represents an incredible opportunity for professionals seeking to contribute to the advancement of cancer treatment and precision medicine. The role not only requires specialization in medical writing but also provides a platform to collaborate with a diverse and skilled team, fostering both personal and professional growth.
This job offer was originally published on remotive.com
This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.
