Medical Writing Fellow

BeiGene, Ltd.; Northern (KY); Hybrid; USD 68,000 - 83,000; Full time

Benefits offered by this job

Equity awards

Employee Stock Purchase Plan

Comprehensive benefits

Job summary

BeOne Medicines Ltd., a growing clinical-stage biotech, is seeking an experienced Document Writing professional to support the development of high-quality regulatory documents for our pipeline. A MS/PhD/PharmD/MD in life science or related field is required by July 2027, with responsibilities spanning study protocols, investigator brochures, and regulatory modules for IND submissions.

You will manage multiple complex documents, collaborate with cross-functional teams, and help shape global

Qualifications

• Advanced degree by July 2027 in life sciences or related field.
• Experience writing clinical/regulatory documents.
• Ability to manage multiple documents and timelines.

Responsibilities

• Manages writing tasks for clinical/regulatory documents.
• Ensures documents adhere to guidelines, templates and SOPs.
• Coordinates with study teams and external partners.

Skills

Regulatory writing

Cross-functional work

Tools

Microsoft Word

Adobe Acrobat

Microsoft Outlook

Excel

PowerPoint

Job description

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.An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science by July 2027.This 1-year position is 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 BeOne pipeline with support from line manager/mentor.. The clinical and regulatory documents include, but are not limited to, clinical study protocol, investigator brochures, clinical study reports, and clinical modules of IND submissions**\\*\\*When applying, please upload curriculum vitae (CV), letter of intent, and your unofficial college transcript\\*\\*** **Essential Functions of the** **J****ob:****Document Writing****:*** Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeOne SOP/WI(s), template(s), and style guide.* Be able to manage multiple documents at the development of complex documents (eg, those with complex content, urgent timeline, or external collaboration) in collaboration with cross-functional teams. Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s).* Provides feedback regarding available document writing template/guidance for the document types with experience.**Project/Program Management****:*** Develops and manages timelines of individual documents. Manages uncertainties and changes to timelines.* Be able to identify the questions/issues that require departmental discussion or team discussion . Be able to identify the potential risks . Proposes resolutions for problems.* Builds connection with study team(s).**Process/Tool Establishment and Optimization****:*** Identifies needs for process/tool optimization and establishment.* Provides feedback regarding available departmental process/tool related to own work.**Training and Mentoring****:*** Participates in and provides feedback regarding available training programs.**Influence****:*** Understands the global MW scope and works to guide study team(s) within the defined scope and responsibility following established processes.Provides insight on global MW deliverables and related knowledge within the department.**Other Qualifications:*** Effective Communication: Explains own work clearly. Be able to escalate questions/issues to appropriate stakeholders at an early stage. Takes part in discussions with different viewpoints, and be able to provide value-added inputs .* Embracing Change: Always seeking and open to new opportunities and changes. Copes well with change and new challenges. Provides feedback regarding specific change activities.* Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work. Provides feedback regarding the innovative ideas and new approaches and uses them to tackle own work tasks and issues in a better way.* Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work. Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).* Mentoring: Provides specific feedback to others within own team as requested.**Computer Skills:**Technical expertise in Microsoft Word, Adobe Acrobat; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.**Travel:**On occasion, as needed.**Pay Rate:** 75K/YearGlobal CompetenciesWhen 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.* 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 ClaritySalary Range: $ - $ per hourBeOne 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 [e-mail].