Senior Medical Writer

BeiGene, Ltd.; United States; Remote; USD 97,000 - 133,000; Full time

Job summary

An innovative global oncology company is seeking a Senior Medical Writer to contribute to the development of affordable cancer treatments. This role involves writing and editing clinical regulatory documents, ensuring they meet strict guidelines and high standards. You will collaborate with cross-functional teams, manage timelines, and uphold the quality of submissions. Join a passionate team dedicated to making a difference in cancer care and be part of a dynamic environment that values collaboration and excellence. If you are driven, detail-oriented, and eager to contribute to impactful projects, this is the opportunity for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Wellness Programs

Employee Stock Purchase Plan

Discretionary Equity Awards

Qualifications

• 4+ years of experience in regulatory medical writing.
• Strong understanding of FDA and ICH guidelines.
• Ability to produce high-quality documents under tight timelines.

Responsibilities

• Write and edit clinical regulatory documents for submissions.
• Coordinate with cross-functional teams to ensure document quality.
• Manage timelines and ensure compliance with regulatory standards.

Skills

Regulatory document writing

Project management

Interpersonal skills

Problem-solving

Attention to detail

Education

BA/BS degree

PhD/PharmD in life sciences

Tools

Microsoft Word

Adobe Acrobat

Electronic document management systems

Microsoft Outlook

Microsoft Excel

Microsoft PowerPoint

Job description

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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:

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, and 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 (eg, 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:

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.

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:

N/A

Computer Skills:

Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint.

Education/Experience Required:

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

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.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Acts Inclusively
• Demonstrates Initiative
• Results-Oriented
• Analytical Thinking/Data Analysis
• Communicates with Clarity

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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:

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, and 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 (eg, 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:

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:

• N/A

Computer Skills:

• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint.

Education/Experience Required:

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

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.

• 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 Clarity

Salary Range: $97,100.00 - $132,100.00 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 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. 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.

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period.

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more aboutBeOne, please visitwww.beigene.com and follow us onLinkedIn ,X (formerly known as Twitter),Facebook andInstagram .

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At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.