Medical Writing Fellow

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

📋 Description

• Provide expert support in the development of clinical and regulatory documents for products within BeOne’s pipeline.

• Assist with documents throughout their development, submission, approval, and life-cycle management processes.

• Compose clinical study protocols, investigator brochures, clinical study reports, and clinical sections of IND submissions.

• Oversee assigned writing tasks, ensuring compliance with regulatory standards and company policies.

• Coordinate multiple intricate documents in collaboration with cross-functional teams and study groups.

• Contribute to the strategic direction and development of documents.

• Offer feedback on writing templates and guidelines.

• Develop and manage timelines, addressing document-related risks and challenges.

• Establish relationships with study teams.

• Recognize opportunities for process and tool improvements.

• Engage in and provide input on training initiatives.

• Guide study teams within the defined scope of medical writing responsibilities.

• Share insights on global medical writing deliverables and relevant departmental expertise.

• Mentor and provide constructive feedback to team members.

⛳️ Requirements

• An advanced degree (MS/PhD/PharmD/MD) in a life science, pharmacy, medical, or health-related field, expected by July 2027.

• Submission of a curriculum vitae (CV), letter of intent, and unofficial college transcript is required when applying.

• Capability to manage assigned writing tasks while adhering to regulatory guidelines, BeOne SOPs/WIs, templates, and style guides.

• Ability to handle multiple intricate documents, urgent deadlines, and external collaborations effectively.

• Proficiency in critically analyzing, synthesizing, and presenting complex information.

• Skill in developing and managing document timelines while identifying risks, issues, and potential resolutions.

• Strong communication skills to convey information clearly and escalate questions or issues as necessary.

• Technical expertise in Microsoft Word and Adobe Acrobat.

• Proficient in Microsoft Outlook, Excel, and PowerPoint.

• Willingness to travel occasionally as required.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• FSA/HSA.

• Life Insurance.

• Paid Time Off.

• Wellness programs.

• Annual bonus plan eligibility for Non-Commercial roles.

• Incentive compensation plan eligibility for Commercial roles.

• Eligibility for discretionary BeOne Medicines Ltd. stock awards.

• Voluntary participation in the Employee Stock Purchase Plan.