Principal Medical Writer
$119K - $159K/yr
... in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to ... and medical writing communities) with guidance from line manager/mentor. Supervisory ...
33 Beigene Medical Writer Jobs Hiring Near You
Principal Medical Writer
$119K - $159K/yr
... in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to ... and medical writing communities) with guidance from line manager/mentor. Supervisory ...
Works effectively within the Global Medical Writing group to produce high-quality, scientifically accurate documents under strict timelines, ensuring consistency between related documents. * Applies ...
Works effectively within the Global Medical Writing group to produce high-quality, scientifically accurate documents under strict timelines, ensuring consistency between related documents. * Applies ...
Works effectively within the Global Medical Writing group to produce high-quality, scientifically accurate documents under strict timelines, ensuring consistency between related documents. Applies ...
Works effectively within the Global Medical Writing group to produce high-quality, scientifically accurate documents under strict timelines, ensuring consistency between related documents. Applies ...
The Senior Director, Clinical Development, Solid Tumors will support BeOne Clinical and Medical ... Train BeiGene colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or ...
The Senior Director, Clinical Development, Solid Tumors will support BeOne Clinical and Medical ... Train BeiGene colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or ...
Support the writing and review safety sections and provide safety expertise for development of ... PharmD, RN or PhD/ MS in a medical field or biological science and 2+ years as a Safety ...
Support the writing and review safety sections and provide safety expertise for development of ... PharmD, RN or PhD/ MS in a medical field or biological science and 2+ years as a Safety ...
Physicians in this role are also expected to provide medical safety assessment. In this role, you ... Lead the writing and review safety sections and provide safety expertise for development of ...
Physicians in this role are also expected to provide medical safety assessment. In this role, you ... Lead the writing and review safety sections and provide safety expertise for development of ...
Support the writing and review safety sections and provide safety expertise for development of ... PharmD, RN or PhD/ MS in a medical field or biological science and 2+ years as a Safety ...
Support the writing and review safety sections and provide safety expertise for development of ... PharmD, RN or PhD/ MS in a medical field or biological science and 2+ years as a Safety ...
The Senior Medical Director, US Medical Affairs for Hematology will report directly to the ... Solid communication (written and verbal), interpersonal, organizational, and cross-functional ...
The Senior Medical Director, US Medical Affairs for Hematology will report directly to the ... Solid communication (written and verbal), interpersonal, organizational, and cross-functional ...
(Senior) Principal Statistical Programmer
$144K - $189K/yr
... Medical Writing, and other partners to address programming-related study deliverables. • Write, test, and validate SAS programs to produce analysis datasets, tables, listings, graphs, and ...
(Senior) Principal Statistical Programmer
$144K - $189K/yr
... Medical Writing, and other partners to address programming-related study deliverables. • Write, test, and validate SAS programs to produce analysis datasets, tables, listings, graphs, and ...
$144K - $189K/yr
... Medical Writing, and other partners to address programming-related study deliverables. • Write, test, and validate SAS programs to produce analysis datasets, tables, listings, graphs, and ...
$144K - $189K/yr
... Medical Writing, and other partners to address programming-related study deliverables. • Write, test, and validate SAS programs to produce analysis datasets, tables, listings, graphs, and ...
The Senior Medical Director, Hematology will support BeOne Clinical and Medical Hematology assets ... High level of communication (written and verbal), interpersonal, organizational, and cross ...
The Senior Medical Director, Hematology will support BeOne Clinical and Medical Hematology assets ... High level of communication (written and verbal), interpersonal, organizational, and cross ...
As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality: * Handles escalated issues or problems with ...
As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality: * Handles escalated issues or problems with ...
As required, supports planning and execution of the Clinical Study Report in collaboration with Biotech and Medical Writing Quality: * Handles escalated issues or problems with the sites in region in ...
As required, supports planning and execution of the Clinical Study Report in collaboration with Biotech and Medical Writing Quality: * Handles escalated issues or problems with the sites in region in ...
As required, supports planning and execution of the Clinical Study Report in collaboration with Biotech and Medical Writing * Quality: Handles escalated issues or problems with the sites in region in ...
As required, supports planning and execution of the Clinical Study Report in collaboration with Biotech and Medical Writing * Quality: Handles escalated issues or problems with the sites in region in ...
Senior Director, Regional Clinical Study Management
$92K - $125K/yr
As required, oversees the planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing. Quality * Sets clear quality expectations and ...
Senior Director, Regional Clinical Study Management
$92K - $125K/yr
As required, oversees the planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing. Quality * Sets clear quality expectations and ...
... and Medical Writing Quality: * Handles escalated issues or problems with the sites in region in ... Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics ...
... and Medical Writing Quality: * Handles escalated issues or problems with the sites in region in ... Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics ...
High level of communication (written and verbal), interpersonal, organizational, and cross ... The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA ...
High level of communication (written and verbal), interpersonal, organizational, and cross ... The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA ...
Manage daily operations of Field Tools across Sales, Market Access, Regional Marketing and Medical ... Excellent written / verbal communication skills and presentation and project management skills.
Manage daily operations of Field Tools across Sales, Market Access, Regional Marketing and Medical ... Excellent written / verbal communication skills and presentation and project management skills.
Associate Manager, US Regulatory Affairs
$103K - $138K/yr
Excellent oral and written communications skills are a must as are superior planning skills • The ... The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA ...
Associate Manager, US Regulatory Affairs
$103K - $138K/yr
Excellent oral and written communications skills are a must as are superior planning skills • The ... The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA ...
Associate Director, Biostatistics
$162K - $212K/yr
Prepares oral and written reports to effectively communicate results of clinical trials to the ... The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA ...
Associate Director, Biostatistics
$162K - $212K/yr
Prepares oral and written reports to effectively communicate results of clinical trials to the ... The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA ...
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Principal Medical Writer
Remote
BeiGene, Inc.
• Health Care and Social Assistance • 5 - 10K employees5,001 - 10,000 employees
$119K - $159K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 17 days ago
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.
General Description:
This 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 BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions. This position is also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed.
Essential Functions of the Job:
Document Writing:
Project /Program Management:
Process/Tool Establishment and Optimization:
Training and Mentoring:
Influence:
Supervisory Responsibilities:
Education Required:
An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.
Bachelor's with 5+, MS with a minimum of 4+ years of regulatory document writing (or equivalent) experience, or PhD/PharmD/MD with a minimum of 2+ years of regulatory document writing (or equivalent) experience.
Computer Skills:
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.
Travel:
On occasion, as needed.
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.
Salary Range: $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. 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 accommodationsus@beonemed.com.
General Description:
This 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 BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions. This position is also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed.
Essential Functions of the Job:
Document Writing:
- Manages the assigned writing tasks and ensures 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). Leads direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s), and be able to help other MWs as requested.
- Contributes to the creation of document writing template/guidance for the document types listed in the General Description part. Leads part of the maintenance of document writing template/guidance for the document types listed in the General Description part.
Project /Program Management:
- Navigates through uncertainties to develop and manage timeline of individual documents and multiple documents (supported by different MWs in one project, eg, works as the MW filing lead for an NDA/BLA/MAA submission). Be able to help other MWs as requested.
- Be able to identify the questions/issues that require departmental discussion or team discussion. Be able to identify the potential risks, make a mitigation plan, and work to resolve problems. Be able to help other MWs in these areas as requested.
- Builds relationship with study team(s) and program team(s) (eg, works as the MW program lead).
- Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes. Be able to help other MWs as requested.
Process/Tool Establishment and Optimization:
- Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.
- Leads part of departmental process/tool optimization. Contributes to departmental process/tool establishment.
- Contributes to cross-functional and cross-company process/tool optimization.
Training and Mentoring:
- Leads (part of) the development of new training programs. Provides instructions/trainings (content-wise/process-wise) to junior MWs.
- Provides technical and operational mentorship to junior MWs (full-time employees and/or contractors/vendors).
Influence:
- Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes.
- Provides topic sharing on regulatory writing and related knowledge within the department (and to cross-functional stakeholders with guidance from line manager/mentor).
- Provides topic sharing on regulatory writing and related knowledge across companies (eg, meetings of DIA and medical writing communities) with guidance from line manager/mentor.
Supervisory Responsibilities:
- None.
Education Required:
An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.
Bachelor's with 5+, MS with a minimum of 4+ years of regulatory document writing (or equivalent) experience, or PhD/PharmD/MD with a minimum of 2+ years of regulatory document writing (or equivalent) experience.
Computer Skills:
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.
Travel:
On occasion, as needed.
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: $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. 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 accommodationsus@beonemed.com.
About BeiGene
Sourced by ZipRecruiter
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,200 colleagues across five continents. For more information, please visit www.beigene.com .
Industry
Health care and social assistance
Company size
5,001 - 10,000 Employees
Headquarters location
Cambridge, MA, US
Year founded
2010