Job Description

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

Job Duties: 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 BeiGene 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.

Minimum Requirements:

• 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.

Special Skill Requirements:

• 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, us.recruiting@beonemed.com.

#LI-DNI

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Tags

Similar Jobs