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18

March

Senior Medical Writer | Melbourne

Novotech - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Senior Medical Writer

Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk.

Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives.

Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary careers, and regular training, learning, and international knowledge-sharing opportunities.

Due to continued growth, Novotech is looking for an experienced Senior Medical Writer to join the Medical Services team to deliver clinical trial success for our clients.

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


Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is committed to offering Equal Employment Opportunities (EEO) where everyone has equal access to employment opportunities based on merit, without fear of discrimination or harassment.

Melbourne, VIC

Health, Medical & Pharmaceutical




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