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.
General Description
This positionis responsible forprovidingexpertisetosupport the development of high-quality, fit-for-purpose clinical and regulatory documents tofacilitatespeed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline.Theclinicalandregulatory documents include, but are not limited to,clinical study protocols,investigator brochures,clinicalstudy reports,regulatory briefing documents,andclinicalmodules ofINDs, NDAs, BLAs, MAAsand other regulatorysubmissions.This position is also responsible for mentoringjuniorMWs (full-time employees and/or contractors/vendors)as needed
Essential Functions of theJob:
Document Writing
Managesthe assigned writing tasks and ensuresthatthe documents adhere torelevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide
Be able tomanagemultipledocuments at the same time,includingthecomplexdocuments(eg,thosewithcomplex content, urgent timeline,orexternal collaboration).Leads direction and strategy setting(includingcriticallyanalyzing, synthesizing, and presentingcomplex information)for document developmentin collaborationwith study team(s),and be able to help other MWsasrequested
Contributes tothecreation of document writing template/guidance forthedocument typeslistedin theGeneral DescriptionpartLeadspart ofthemaintenance of document writingtemplateguidance forthedocument typeslistedin theGeneral Descriptionpart
Project /Program Management
Navigatesthrough uncertainties to develop and manage timeline of individual documentsand multiple documents (supported by different MWs in one project,eg, works as the MW filing lead for anNDA/BLAMAAsubmission).Be able to help other MWsasrequested
Be able toidentifythe questions/issues that require departmental discussion or team discussionBe able toidentifythe potential risks,makeamitigation plan, and work toresolve problems.Be able to help other MWsin these areasasrequested
Buildsrelationshipwith study team(s) and program team(s) (eg, works as the MW program lead).
Understands the role of own documentswithin the larger dossier andvoices outany impact on upstream and downstream processes.Be able to help other MWsasrequested
Process/Tool Establishment and Optimization
Proactivelyidentifiesneeds for process/tool optimization andestablishment, andproposessolutions.
Leads part of departmental process/tool optimization. Contributes to departmental process/tool establishment
Contributes to cross-functionalandcross-companyprocess/tool optimization
Training and Mentoring
Leads(part of)the development of new training programs.Provides instructions/trainings (content‑wiseprocess-wise) tojuniorMWs.
Provides technical and operational mentorship tojunior MWs(full-time employees and/or contractors/vendors)
Influence
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 (andto cross-functional stakeholders with guidance from line manager/mentor).
Provides topic sharing on regulatory writing and related knowledge across companies (eg, meetings of DIA and medical writing communities)with guidance from line manager/mentor
Supervisory Responsibilities:
None.
Education Required:
An advanced degree (MS/PhD/PharmD/MD) in life science,pharmacy,medical, orhealth-related science is preferred.
Bachelor'swith 5+,MS with a minimum of4+years of regulatory document writing (or equivalent) experience, orPhD/PharmD/MD with a minimum of2+years of regulatory document writing (or equivalent) experience.
Computer Skills:
Technicalexpertisein Microsoft Word, Adobe Acrobat, and electronic document managementsystems;proficiencyin Microsoft Outlook, Excel,and PowerPoint, etc.
Travel:
On occasion, as needed.
Global Competencies
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: $119,300.00 - $159,300.00 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 of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com
Effective March 17, 2025, The U.S. subsidiary of BeiGene, Ltd. has changed its name to BeOne Medicines USA, Inc. This change comes ahead of our anticipated global rebranding to BeOne Medicines Ltd. and redomiciliation to Switzerland, pending shareholder approval. The new name reflects our commitment to develop innovative medicines and partner with the global community to help as many patients with cancer as possible.
To learn more about BeOne Medicines, please follow our new LinkedIn profile @BeOne Medicines.
