Medical Writer

This is a fully remote position, open to applicants in Singapore.

📋 Description

• Conduct research, compose, and refine clinical documents, such as clinical study reports, clinical study protocols, outlines for clinical plans, sections of regulatory submission documents, and scientific manuscripts.

• Utilize therapeutic expertise, knowledge of clinical drug development, and relevant experience to aid in the development of drugs, biologics, devices, and other human-use products.

• Write, review, and edit routine documents independently, including protocols, CSRs, IBs, and scientific manuscripts.

• Independently analyze non-clinical and clinical data in technical reports.

• Execute literature searches and reviews.

• Engage in project teams and coordinate specifications for reports and data analyses.

• Organize and conduct peer and team quality-control reviews for assigned projects.

• Examine relevant documents and collaborate with functional leaders and project managers to comprehend project timelines.

• Offer writing support for more intricate clinical documentation under suitable departmental supervision.

• Carry out additional tasks as assigned by the line manager.

⛳️ Requirements

• Bachelor's or Master's degree from an accredited institution in Life Sciences or Health-related Sciences.

• 2–4 years of experience in science or medical-related writing.

• Strong foundation in clinical medicine or pharmaceutical sciences.

• Familiarity with common medical and clinical research terminology.

• Understanding of ICH-GCP and essential NMPA/FDA requirements.

• Knowledge of the entire clinical trial process and fundamental statistical principles.

• Capability to independently draft moderately complex documents, including protocols, CSR drafts, and investigator brochures.

• Good skills in data interpretation.

• Proficient in reading and writing in both English and Chinese.

• Fluent in reading, writing, and speaking English; capable of independently drafting English documents and communicating with international clients or colleagues.

• Proficient in PC-Windows and MS Word; familiar with basic document templates.

• Excellent written, oral communication, and presentation abilities.

• Ability to manage timelines for 1–2 projects.

• 1–3 years of experience in a pharmaceutical company or CRO developing drugs for human use.

• Basic experience in clinical study design and protocol development/writing, including taking part in protocol drafting.

• Fundamental knowledge of regulatory submission requirements and ICH CSR writing guidelines.

🏝️ Benefits

• Competitive compensation: a customized salary and benefits package that reflects skills and experience.

• Hybrid or remote working options, depending on the role and location.

• Opportunities for career growth and learning.

• Access to a global network of scientific leaders.

• Employee wellbeing programs that promote work-life balance, health, and team connection.

• Global engagement surveys.

• Recognition programs.

• Team-building events.

• Exposure to a variety of international projects and clients.