Associate CMC Technical Writer
Working with UsChallenging.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
The Associate CMC Technical Writer is responsible for preparing CMC elements of regulatory filings under a Technical Writer's guidance and supporting the regulatory activities for Marketing Applications and post-approval submissions.
This role requires effective collaboration across technical functions to deliver on timelines for submissions.
The candidate is expected to have a thorough understanding of regulatory guidelines.
The position routinely interfaces with experts in Manufacturing Sciences and Technology, Operations, Analytical Sciences, Quality, and Regulatory Sciences.
The successful candidate will work effectively in cross-functional project teams and also independently to accomplish company goals.
Job Responsibilities :
Author under supervision CMC elements of regulatory filings.
Manage the logistical process for regulatory submissions including Marketing applications and/or post-approval submissions while interfacing across the BMS network.
Documents included:
BLA, MAA, NDA, Briefing Documents, PAS, CBE-0, CBE-30, Variations, HA Queries etc.
Ensure final document compliance to make certain submission content meets formatting requirements.
Schedule and facilitate submission reviews and consensus meetings.
Manage the finalization of drafts for next phase review.
Facilitate data verification to ensure accuracy of data following internal SOP.
Participate in initiatives to promote standardization of submission process and/or content within organization.
Participate on various cross-functional project teams, interact with technical experts, regulatory and other key partners both internal and external to the company as necessary.
Must possess the ability to support multiple projects.
Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
Leadership :
Work under supervision and collaborate with other teams.
Deliver results in line with project and team objectives.
Qualifications :
Bachelor's degree or equivalent in relevant discipline with a minimum of 3 - 5 years' relevant experience.
Masters degree with 0 - 2 year's relevant experience.
Time spent in advanced degree programs may be considered as equivalent relevant experience.
Excellent time management, organizational, and communication skills are required along with proficient navigation of electronic systems.
Must have a working knowledge of regulatory submissions.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions.
Proven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Communication Electronic Systems Filing Hardworking And Dedicated Interpersonal Skills Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
The Associate CMC Technical Writer is responsible for preparing CMC elements of regulatory filings under a Technical Writer's guidance and supporting the regulatory activities for Marketing Applications and post-approval submissions.
This role requires effective collaboration across technical functions to deliver on timelines for submissions.
The candidate is expected to have a thorough understanding of regulatory guidelines.
The position routinely interfaces with experts in Manufacturing Sciences and Technology, Operations, Analytical Sciences, Quality, and Regulatory Sciences.
The successful candidate will work effectively in cross-functional project teams and also independently to accomplish company goals.
Job Responsibilities :
Author under supervision CMC elements of regulatory filings.
Manage the logistical process for regulatory submissions including Marketing applications and/or post-approval submissions while interfacing across the BMS network.
Documents included:
BLA, MAA, NDA, Briefing Documents, PAS, CBE-0, CBE-30, Variations, HA Queries etc.
Ensure final document compliance to make certain submission content meets formatting requirements.
Schedule and facilitate submission reviews and consensus meetings.
Manage the finalization of drafts for next phase review.
Facilitate data verification to ensure accuracy of data following internal SOP.
Participate in initiatives to promote standardization of submission process and/or content within organization.
Participate on various cross-functional project teams, interact with technical experts, regulatory and other key partners both internal and external to the company as necessary.
Must possess the ability to support multiple projects.
Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
Leadership :
Work under supervision and collaborate with other teams.
Deliver results in line with project and team objectives.
Qualifications :
Bachelor's degree or equivalent in relevant discipline with a minimum of 3 - 5 years' relevant experience.
Masters degree with 0 - 2 year's relevant experience.
Time spent in advanced degree programs may be considered as equivalent relevant experience.
Excellent time management, organizational, and communication skills are required along with proficient navigation of electronic systems.
Must have a working knowledge of regulatory submissions.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions.
Proven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Communication Electronic Systems Filing Hardworking And Dedicated Interpersonal Skills Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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