Beigene

Beigene

Principal Medical Writer

Remote (US) · Principal · Full-time

Sponsorship not specified$119k-$159kDetected 22 days ago
Data AnalysisExcelCollaborationProblem SolvingMentoringMicrosoft Office

About the role

  • 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.
  • This position is also responsible for mentoring MWs (full-time employees and/or contractors/vendors) as needed.

Responsibilities

  • BS with a minimum of 5+ years of regulatory document writing (or equivalent) experience, Masters with 4+ or PhD/PharmD/MD with a minimum of 2+ years of regulatory document writing (or equivalent) experience.
  • Manages the assigned writing tasks and e nsures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
  • Be able to manage multiple documents at the same time, including the complex documents ( eg, those with complex content, urgent timeline, or external collaboration ).
  • Proactively leads direction and strategy setting ( including critically analyz ing, synthesiz ing, and present ing complex information ) for document development in collaboration with study team(s), and be able to guide other MWs.
  • Navigate s through uncertainties to develop and manage timeline of individual document s and multiple documents (supported by different MWs in one project, eg, works as the MW filing lead for a n NDA/BLA /MAA submission), includ ing those for complex projects.
  • Builds strong and in-depth relationship with study team(s) and program team(s) ( eg, works as the MW program lead).
  • Understands the role of own documents with in the larger dossier and voices out any impact on upstream and downstream processes. Be able to guide other MWs and provide suggestions.

Skills

  • On occasion, as needed.
  • Global Competencies
  • 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

Compensation

  • $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.
  • 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.

Benefits

  • A n a dvanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.
  • Education Required:
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
  • 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.

Company info

  • Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.
  • Leads departmental process/tool optimization. Leads (part of) departmental process/tool establishment.
  • Leads part of cross-functional process/tool optimization. Contributes to cross-function process/tool establishment.
  • Contributes to cross-company process/tool optimization.

Equal opportunity

  • We are proud to be an equal opportunity employer.
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This listing is sourced directly from Beigene's careers page and normalized into a canonical job model.