Telix Pharmaceuticals (AMER)

Medical Writer

USA- Remote

Sponsorship not specifiedDetected 28 days ago

Project ManagementFDA RegulatoryExperimental DesignLeadershipCommunicationCollaborationAdaptabilityMicrosoft Office

About the role

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix The Medical Writer will contribute to the achievement of Telix's strategic goals by leading and driving the writing process.

This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development.
Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others.
Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine.

Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges

Bachelor with a focus in science or related field required
Advance degree preferred
Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles.
Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy.
The ability to accurately and clearly present clinical data
strong verbal, written, and interpersonal communication skills
and proficiency in Microsoft Word are required.
Strong command of English language, grammar, style, logical progression.

Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Telix Pharmaceuticals is an equal opportunity employer.

We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
The Medical Writer will contribute to the achievement of Telix's strategic goals by leading and driving the writing process.
This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data.

Our mission is to deliver on the promise of precision medicine through targeted radiation.
At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity.
You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.

This listing is sourced directly from Telix Pharmaceuticals (AMER)'s careers page and normalized into a canonical job model.