Medical Writing responsibilities on an individual project will be detailed in the Project Agreement. They include, but are not limited to:
- Plan and prepare high-quality medical writing deliverables (eg, clinical trial protocols, protocol amendments, investigational brochures, clinical study reports, pharmacovigilance periodic reports, and publications).
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- Work with Project Manager to facilitate the review, quality check and assembly of medical writing deliverables according to agreed timelines.
- Partner with sponsors/ clients to ensure on-time delivery of quality documents.
- Ensure adherence to Novotech procedures / practices, and industry / international standards.
Minimum Qualifications & Experience:
- A bachelor's degree in Life Sciences/Health-related Sciences or equivalent experience; post-graduate qualifications (eg, PhD or MD) preferred.
- A minimum of 2 to 4 years medical writing experience within the biopharmaceutical industry or CRO.
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
- Extensive regulatory writing experience including clinical study reports and clinical trial protocols for phase 1 to 3 studies and post-marketing commitments.
- Ability to manage multiple and varied tasks with enthusiasm and to prioritize work while paying attention to details.
- Expert MS Office skills.
- Excellent written, verbal and presentation skills; fluency in written and spoken English.
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.
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