[Hiring] Senior Medical Writer @BeiGene

Role Description

The Senior Medical Writer 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. Clinical regulatory documents include, but are not limited to:

• Study reports
• Clinical study protocols or amendments
• Investigator brochures
• Clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents

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 (e.g., SOPs, Work Instructions, templates, style guide, etc.).
• Ensure clinical documents adhere to BeOne standards and regulatory guidelines.
• Coordinate and manage contract medical writers as needed.

Qualifications

• 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.

Requirements

• Minimum 4 years' relevant industry experience as a regulatory medical writer.
• BA/BS degree; PhD/PharmD in life sciences preferred.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Eligible for discretionary equity awards and participation in the Employee Stock Purchase Plan.
• Non-Commercial roles are eligible to participate in the annual bonus plan.
• Commercial roles are eligible to participate in an incentive compensation plan.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors 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.

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 [email protected].