Medical Writer

6 days ago

Sydney, New South Wales, Australia Novotech Asia Full time

**About the role**

As a Novotech Medical Writer, you will be responsible for the efficient preparation of high-quality, medical writing deliverables that support the client's clinical development programs.

**Responsibilities**
- Preparation of clinical and regulatory documents, including but not limited to integrated statistical/clinical reports, protocols, investigator brochures, regulatory submissions, manuscripts for publication and other documents as required.
- Liaison with clients, external consultants, colleagues and review of current literature sources to ensure the document is developed in alignment with the client's goals, local regulations, Good Clinical Practice (GCP).
- Working with cutting edge early phase technology across multiple therapeutic areas based on local and international client requirements. Occasional travel may be required.

**Experience and Qualifications**
- Qualifications required are a life science focused BSc (or equivalent), and a higher degree (e.g. a life science focused MSc or PhD).
- Must have experience writing regulatory documentation including Clinical Study Reports and Clinical Protocols
- Preferably 5 years practical/technical experience in product development from working within SME biotech, or Medical Writing experience working in a CRO
- A good understanding of drug development is essential and general awareness of regulatory affairs is sufficient but more detailed insight into the regulatory environment for medicinal products would be an advantage
- Excellent verbal and written communication skills are essential
- Pro-activity, adaptability, team work and collaboration are essential

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.

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