Principal Medical Writer

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

BeOne Medicines USA, Inc. seeks Principal Medical Writer in Cambridge, MA:

Responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life‑cycle management of products in Bei Gene pipeline. Also responsible for mentoring junior MWs (full‑time employees and/or contractors/vendors) as needed. Manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration).

Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s). Contribute to the creation and maintenance of document writing template/guidance for the document types listed in the General Description part. Lead part of the maintenance of document writing template/guidance for the document types listed in the General Description part.

Identify the questions/issues that require departmental discussion or team discussion with guidance from line manager/mentor. Identify the potential risks and make a mitigation plan with guidance from line manager/mentor. Resolves problems with guidance from line manager/mentor (eg, takes concrete actions according to the aligned decisions). Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes.

Provide technical and operational mentorship to junior MWs (full‑time employees and/or contractors/vendors). Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes. Provides topic sharing on regulatory writing and related knowledge within the department and across the company (and to cross‑functional stakeholders with guidance from line manager/mentor).

Full‑time telecommuting is an option.

• PhD (or its foreign degree equivalent) in Biotechnology, Engineering (any field), Biochemistry, or a related quantitative discipline, and 2 years of experience in the job offered or in any occupation in related field, OR Master’s degree (or its foreign degree equivalent) in Biotechnology, Engineering (any field), Biochemistry, or a related quantitative discipline, and 5 years of progressively responsible experience in the job offered or in any occupation in related field.

• Writing clinical study reports;
• Writing protocols;
• Writing protocol amendments;
• Analyzing, Synthesizing, and Presenting Complex Information utilized in Medical Documentation;
• Working with regulatory authorities from multiple regions. Any suitable combination of education, training and/or experience is acceptable.

Full‑time telecommuting is an option.

Disregard the below range, the selected candidate will earn a wage of $137,100 - $171,400 per annum.

Submit resume with references to:
Req.#: L24-150320 at: ATTN:
Amy Nobriga,

#LI-DNI

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self‑Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results‑Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Salary Range: $ - $ annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job‑related skills, depth…