Medical Writer/Senior Medical Writer
3 weeks ago
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. 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. 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/Senior 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.
This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. 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.
What you'll do
- Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments.
- Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly.
- Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
- Collaborate with project teams to respond to heath authority questions and requests.
- Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
- Maintain knowledge to enable ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline.
About you
- Bachelor of Science a science or related field required; Advance degree preferred
- 8+ years of experience in pharmaceutical industry with 5+ years of experience in regulatory writing required for Medical Writer; 8+ years’ experience in regulatory writing required for Senior Medical Writer
- Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must.
- 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. Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting.
- Experience and proficiency with document templates, document toolbars and proper version control.
- Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail.
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. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. 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.
VIEW OUR PRIVACY POLICY HERE
- Apply Now
-
Medical Writer
2 weeks ago
Melbourne, Australia TQSolutions Full timeAbout our business Accelagen is a leading, full-service Pharmaceutical and Medical Device Development Organisation. The Accelagen team is comprised of clinical specialists who provide wide ranging services and support in the development and implementation of clinical trials, for both local and international clients. The Biometrics unit is growing at a...
-
Bid Writer
5 days ago
Melbourne, Australia Ventia Pty Limited Full timeBid Writer **Date**:20 Mar 2024**Location**:Melbourne, VIC, AU, 3000**Company**:Ventia**About the role** Ventia is seeking a full-time Senior Bid Writer to play a pivotal role in securing opportunities for our ANZ Infrastructure Services business. You will produce high quality bid content and work collaboratively with teams on multi-authored documents to...
-
Technical Writer
1 week ago
Melbourne, Australia Technology People Australia Full timeTechnical Writer - 9 Month Contract - Melbourne - My client is looking for an Infrastructure Technical Writer to join at a pivotal point in a project. This opportunity is with a large federal government client, where you will be responsible for creating technical documents, diagrams and manuals. Key Skills: - Provide technical documentation for network...
-
Bid Writer
7 days ago
Melbourne, Australia Blackbook Executive Full timeUtilize your Bid Writing skills! - Facilities Management background highly desired - Work for a market leader Our client is a leading Facilities Management business who are growing exponentially. As a result, they are seeking a Bid Writer to join their energetic and high-performing team. As the Bid Writer, you will be responsible for the effective...
-
Bid Writer
3 weeks ago
Melbourne, Australia Ventia Pty Limited Full time**Bid Writer**: - Date: 25 Jul 2023- Location: Melbourne, VIC, AU, 3000- Company: Ventia**About the Role** Ventia is currently seeking a **Bid Writer** to support their Defence & Social Infrastructure (D&SI) business. This is a unique opportunity for a highly-skilled Bid Writer to create persuasive writing solutions for some of the highest profile projects...
-
Bid Writer
1 month ago
Melbourne, Australia Laurence Full timeOur client is a global services business, providing essential services to health, education, government, aviation, energy and infrastructure. They are searching for an outstanding Bid Writer to join their team. As such, the purpose of this role is to provide bid support with the identification, planning, project management, development, writing, review,...
-
Senior Writer and Editor
3 weeks ago
Melbourne, Australia Monash University. Full timeThe Opportunity Are you ready to be a voice for change? Climateworks Centre is seeking a Senior Writer and Editor to craft compelling narratives that inspire action and drive the climate agenda forward. Join us and play a pivotal role in our mission to bridge the gap between climate research and real-world action. As a Senior Writer and Editor,...
-
Senior Writer and Editor
1 week ago
Melbourne, Australia Monash University. Full timeThe Opportunity Are you ready to be a voice for change? Climateworks Centre is seeking a Senior Writer and Editor to craft compelling narratives that inspire action and drive the climate agenda forward. Join us and play a pivotal role in our mission to bridge the gap between climate research and real-world action. As a Senior Writer and Editor,...
-
Bid Writer
1 month ago
Melbourne, Australia Laurence Full timeMelbourne, Australia Our _client_ is a global services business, providing essential services to health, education, government, aviation, energy and infrastructure. They are searching for an outstanding Bid Writer to join their team. As such, the purpose of this role is to provide bid support with the identification, planning, project management,...
-
Bid Writer
2 months ago
Melbourne, Australia Laurence Full timeMelbourne, Australia Our client is a global services business, providing essential services to health, education, government, aviation, energy and infrastructure. They are searching for an outstanding Bid Writer to join their team. As such, the purpose of this role is to provide bid support with the identification, planning, project management,...
-
Bid Writer
1 week ago
Melbourne City Centre, Australia HAYS Full timeBid Writer, Construction Company, Melbourne Temporary Assignment: Ongoing Are you an experienced Bid Writer looking for a challenging new role within a dynamic and growing construction company in Melbourne? If so, we want to hear from you! Your new company A Tier 2 construction company in Melbourne is a mid-sized firm that typically handles medium to...
-
Bid Writer
2 months ago
Melbourne, Australia Spotless Full time**Job no**: 590442 **Work type**: Full Time **Location**: Melbourne **Categories**: Strategy & Business Development, Design, Planning & Scheduling Our Facilities and Asset Services business has an opportunity for a **Bid Writer** to join the Growth and Development team. As an experienced Bid Writer, you will develop content for bids and tenders based on...
-
Technical Writer
2 weeks ago
Melbourne, Australia Cubic Corporation Full timeBusiness Unit: Cubic Transportation Systems Company Details: Cubic offers an opportunity to provide innovative technology for government and commercial customers around the globe, helping to solve their future problems today. We’re the leading integrator of payment and information technology and services for intelligent travel solutions worldwide, and the...
-
Bid Writer
6 days ago
Melbourne, Australia Austcorp Executive Full timeLarge organisation servicing ANZ clients and multiple sector portfolios - Write on medium to large proposals + opportuntiy to manage end to end process - Melbourne central location with flexible work arrangements **About Our Client**: Our client is a facilities services organisation seeking a Bid Writer to help in securing additional contracts to their...
-
Content Writer
2 months ago
Melbourne, Australia Salt Recruitment Full time**Content Writer** **Freelance** **CBD Based** Our client is a growing IT Consultancy undergoing a rebrand, which includes a brand new website. We are looking for a freelance Content Writer who will write a number of case studies to be published on their new site, highlighting the brief, challenge, and solution. This role requires a combination of...
-
Content Writer
2 months ago
Melbourne City Centre, Australia Peoplebank Full timeLocation: - Melbourne CBD- Job Type: - Contract- Posted: - about 4 hours ago- Contact: - Sumi Dahal- Discipline: - General IT - Reference: - 260310Our esteemed client, one of Australia's top four banks, is actively seeking a skilled Content Writer/Technical Writer to join their dynamic team. You will play a crucial role in providing content editing and...
-
Assessment Writer
2 months ago
Melbourne, Australia RMIT University Full timeOverview: - Full Time, Fixed Term until 31/12/2023- - Salary Level HEW 7 + 17% Superannuation and Flexible Working Arrangements- - Based at the Melbourne CBD campusAbout the Position - The Assessment Writer will play a key role in designing innovative assessment for a project, funded by the Department of Education (DET). RMIT and another leading TAFE have...
-
Technical Writer
4 days ago
Melbourne, Australia Talent International Full time**Job Details**: **Location** Melbourne **Salary** Negotiable **Job Type** Full Time **Ref** BBBH101915_1684369555 **Contact** Donal McCann **Posted** about 2 hours ago - CBD Location - Hybrid Working Arrangement - Create Case Management System User Guides **The role** This Government agency is seeking an experienced Technical Writer to create...
-
Lifestyle Writer
2 months ago
Melbourne, Australia Time Out Australia Full time**Lifestyle Writer / Editor, Time Out Melbourne** **Location**: Melbourne **Department**: Content **Time Out Australia** is looking for an enthusiastic and passionate Lifestyle Writer (or Editor, dependent upon the successful applicant’s experience) to join the Melbourne team. The position is full time, and the writer/editor will be covering a wide...
-
Proposal Writer
2 weeks ago
Melbourne City Centre, Australia HAYS Full timeThis is an exciting opportunity for a Proposal Writer to join an expanding organisation who are globally known **Your new company** This is an exciting opportunity for a Proposal Writer to join an expanding organisation who are globally known for their Advanced Technology Solutions. This company provides safe, secure, efficient and environmentally...