Verified Job
Content Writer
Bristol Myers Squibb Technical Writer
Content Writer
#788028
Remote / WFH
Bristol Myers Squibb
Job Description
Qualifications
Required Bachelors degree in Biology or related discipline with a minimum of 2 years experience
Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery
Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required
Experience in bio tech/pharma e2eproduct development required
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines
Responsibilities
Work Schedule: Mon-Friday (normal business hours)
This individual will be responsible for delivering CMC documentation (dossier and supporting documents)to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application
This role requires effective collaboration across technical functions to deliver on timelines for submissions
The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences
The successful candidate will work effectively in cross-functional project teams to accomplish company goals
Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports
Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets
Manage the logistical process and detailed timeline for regulatory submissions
Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy
Provide input and scientific oversight for content generation for Module 2.3 and 3
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process
Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections
Ensures content clarity/consistency in messaging across dossier
Facilitate and manage the data verification process
Assist with dossier creation and system compliance for regulatory submissions
Coordinate response authoring, review and data verification to queries from HA for submissions
Track upcoming submissions and ongoing submission progress
Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker
Represent Tech Writing and Document management in cross-functional CMC teams as required
Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions
Collaborate with external suppliers as needed for CTD content and review
Support and implement continuous process improvement ideas and initiatives
Train others on procedures, systems access and best practices as appropriate
Mentor and train employees on the document management process
Work independently under supervision and collaborate with other teams
Take ownership of the section formatting, language check, connections to other sections / tables
Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy
Occasionally to other local NJ sites for larger team meetings
Job description
50% onsite required
Work Schedule: Mon-Friday (normal business hours)
Job Description:
This individual will be responsible for delivering CMC documentation (dossier and supporting documents)to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.
Primary Responsibilities:
• Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
• Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
• Manage the logistical process and detailed timeline for regulatory submissions.
• Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
• Provide input and scientific oversight for content generation for Module 2.3 and 3.
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
• Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
• Ensures content clarity/consistency in messaging across dossier.
• Facilitate and manage the data verification process.
• Assist with dossier creation and system compliance for regulatory submissions
• Coordinate response authoring, review and data verification to queries from HA for submissions.
• Track upcoming submissions and ongoing submission progress
• Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker.
• Represent Tech Writing and Document management in cross-functional CMC teams as required.
• Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
• Collaborate with external suppliers as needed for CTD content and review.
• Support and implement continuous process improvement ideas and initiatives.
• Train others on procedures, systems access and best practices as appropriate.
• Mentor and train employees on the document management process
• Work independently under supervision and collaborate with other teams.
Competencies & Experiences:
• Required Bachelors degree in Biology or related discipline with a minimum of 2 years experience
• Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
• Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
• Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
• Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
• Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
• Experience in bio tech/pharma e2eproduct development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Take ownership of the section formatting, language check, connections to other sections / tables.
• Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy.
Travel:
• Occasionally to other local NJ sites for larger team meetings. (2-3 times a year)
Required Bachelors degree in Biology or related discipline with a minimum of 2 years experience
Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery
Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required
Experience in bio tech/pharma e2eproduct development required
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines
Responsibilities
Work Schedule: Mon-Friday (normal business hours)
This individual will be responsible for delivering CMC documentation (dossier and supporting documents)to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application
This role requires effective collaboration across technical functions to deliver on timelines for submissions
The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences
The successful candidate will work effectively in cross-functional project teams to accomplish company goals
Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports
Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets
Manage the logistical process and detailed timeline for regulatory submissions
Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy
Provide input and scientific oversight for content generation for Module 2.3 and 3
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process
Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections
Ensures content clarity/consistency in messaging across dossier
Facilitate and manage the data verification process
Assist with dossier creation and system compliance for regulatory submissions
Coordinate response authoring, review and data verification to queries from HA for submissions
Track upcoming submissions and ongoing submission progress
Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker
Represent Tech Writing and Document management in cross-functional CMC teams as required
Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions
Collaborate with external suppliers as needed for CTD content and review
Support and implement continuous process improvement ideas and initiatives
Train others on procedures, systems access and best practices as appropriate
Mentor and train employees on the document management process
Work independently under supervision and collaborate with other teams
Take ownership of the section formatting, language check, connections to other sections / tables
Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy
Occasionally to other local NJ sites for larger team meetings
Job description
50% onsite required
Work Schedule: Mon-Friday (normal business hours)
Job Description:
This individual will be responsible for delivering CMC documentation (dossier and supporting documents)to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.
Primary Responsibilities:
• Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
• Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
• Manage the logistical process and detailed timeline for regulatory submissions.
• Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
• Provide input and scientific oversight for content generation for Module 2.3 and 3.
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
• Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
• Ensures content clarity/consistency in messaging across dossier.
• Facilitate and manage the data verification process.
• Assist with dossier creation and system compliance for regulatory submissions
• Coordinate response authoring, review and data verification to queries from HA for submissions.
• Track upcoming submissions and ongoing submission progress
• Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker.
• Represent Tech Writing and Document management in cross-functional CMC teams as required.
• Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
• Collaborate with external suppliers as needed for CTD content and review.
• Support and implement continuous process improvement ideas and initiatives.
• Train others on procedures, systems access and best practices as appropriate.
• Mentor and train employees on the document management process
• Work independently under supervision and collaborate with other teams.
Competencies & Experiences:
• Required Bachelors degree in Biology or related discipline with a minimum of 2 years experience
• Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
• Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
• Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
• Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
• Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
• Experience in bio tech/pharma e2eproduct development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Take ownership of the section formatting, language check, connections to other sections / tables.
• Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy.
Travel:
• Occasionally to other local NJ sites for larger team meetings. (2-3 times a year)
