AddressPrincipal Medical Writer | Australia based
Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives.
Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas.
Our people are critical in meeting organizational, and client objectives and we place a strong emphasis on creating a collaborative, transparent, and inclusive work environment where everyone is supported to achieve.
Responsibilities
- Plan and prepare high-quality medical writing deliverables (e.g., clinical trial protocols, protocol amendments, investigational brochures, clinical study reports, common technical document Module 2.5 and 2.7, pharmacovigilance periodic reports, and publications).
- Work with Project Manager to help the review, quality check and assembly of medical writing deliverables according to agreed timelines
- Partner with sponsors / clients to ensure the on-time delivery of quality documents
- Ensure adherence to Novotech procedures / practices, and industry / international standards
- Resource planning and resource allocation.
- Significantly contributes to the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high-quality medical writing deliverables.
Experience and Qualifications
- A bachelor's degree in Life Sciences / Health-related Sciences or equivalent experience; post-graduate qualifications (e.g., PhD or MD) preferred.
- A minimum of 6 years medical writing experience within the biopharmaceutical industry or CRO.
- Extensive regulatory writing experience including clinical study reports and clinical trial protocols for phase 1 to 3 studies and post-marketing commitments
- A minimum of 3 years in a supervisory role (i.e., as line a manager or mentor)
- A comprehensive understanding of clinical research, the clinical development process, and applicable regulatory guidelines.
- A comprehensive understanding of medical writing processes, standards and issues.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
