Ref #: 28796

Employment type: Permanent - Full-Time

Location: China-Beijing/Shanghai

Posted: 29-Apr-2021

Description

Overview

As a Medical Writer you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.

PRINCIPAL RESPONSIBILITIES:
• Prepares basic clinical documents under close supervision such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, protocol amendments, initial IBs, IB addenda. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
• Helps prepare sections of more complex clinical documents under close supervision (eg, IB updates, Phase 2/3 CSRs and appendices, RMP annexes, protocol T&E schedules).
• Performs document QC, abbreviations, references, literature searches, table creation, and other basic tasks with some supervision.
• Participates in cross-functional document planning and review meetings.
• Works in a team environment with some guidance provided, and takes a somewhat active role (under close supervision) on assigned projects with respect to timing, scheduling, and tracking.

ADDITIONAL RESPONSIBILITIES:
1. Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide.
2. Regularly meets with manager and mentors, and attends departmental meetings.
3. Attends cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).
4. Completes all time reporting, training, and metrics database updates as required.
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Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.
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