Medical Writer

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

Must have experience writing regulatory documentation including Clinical Study Reports and Clinical Protocols.

Qualifications required are a life science focused BSc (or equivalent), and a higher degree (e.g., a life science focused MSc or PhD).

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 one 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 talking to you about working at Novotech.

About Us

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices acrossAsia-Pacific,North America, andEurope.

Novotech employs over

• employees and has over
• site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management.

Novotech obtained the ISO

Together with the ISO

About the Team

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market.

This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.

At Novotech you will work alongside empowered teams with a shared commitment to success.

Strategic vs transactional mindset.

Ability to gain insights and make proactive decisions quickly.

Culture that fosters partnership and collaboration, where every voice is heard and valued.

Ongoing support from senior stakeholders and leadership team.

Job Info

Job Identification

Posting Date 12 / 09 / 2025, 11 : 09 PM

Job Schedule Full time

Locations Level 13, 440 Collins Street, Melbourne, Victoria,

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