BeiGene 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.
Job Summary:
The Senior Manager, Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines and to oversee these activities in more junior medical writers. Clinical regulatory documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. The Manager, or Senior Manager, Medical Writing is also responsible for mentoring junior writers and managing direct reports, if applicable.
Essential Functions of the job:
Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles
Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
Review and edit documents, including those authored by others both internally and externally
Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)
Ensure clinical documents adhere to BeiGene standards and regulatory guidelines
Manage and mentor direct reports as applicable
Coordinate and manage contract medical writers as needed
Qualifications:
Knowledge and Skills
Demonstrated ability to communicate and write English clearly, concisely, and effectively
Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands
Independently motivated with good problem-solving ability
Excellent interpersonal skills; a team player
Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
Strong project management skills
Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments
Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines
Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus
The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents
Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
Ability to comply with company and/or industry style guides and templates
Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint
Supervisory Responsibilities:
Mentors junior medical writers and may manage staffing and performance, including, but not limited to, hiring, training, coaching, and performance reviews for direct reports.
Computer Skills:
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint.
Education/Experience Required:
7+ years of relevant industry experience as a regulatory medical writer with a BA/BS degree.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.
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