Regulatory Documentation Manager Jobs in Renton, WA

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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.

Position Summary

Leads the establishment and ongoing development of a Therapeutic Area (TA) team of scientific writers. Demonstrates in-depth expertise in the relevant TA and specific assets, enabling effective leadership in the creation of content libraries when warranted. Applies advanced regulatory documentation skills to guide and/or support the implementation of new processes, tools, and continuous improvements within the scope of departmental responsibilities. Demonstrates strong managerial, scientific, and customer-focused leadership skills. Applies regulatory documentation standards that enhance efficiency and ensure consistency across the entire development and life cycle management of TA assets, across geographic regions. Leads strategic planning for document automation and leads innovative initiatives to support those goals.

The person in this role will be required to report to the Lawrenceville, New Jersey location.

Duties/Responsibilities

• Work with Head of GSRD and direct reports to develop and lead the TA writing teams in support of global regulatory documentation for the BMS R&D goals and objectives.
• Establish strategic partnerships with other functions within BMS to maintain fully integrated and standardized processes and systems and ensure alignment of roles and responsibilities to meet BMS R&D objectives and priorities.
• Establish and maintain documentation standards, templates, and best work practices that are consistent with internal and external guidelines for regulatory documentation and submissions; facilitate the development of innovative solutions to resolve issues.
• Lead scientific writers in producing high-quality strategically written documents based on good documentation practices within established optimum timelines.
• Seek exceptional talent from across the industry and within BMS.
• Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support (if applicable) for documents not covered adequately by in-house resources.
• Review regulatory, clinical, and safety documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements.
• Support skillset development for scientific writers as needed for BMS pipeline, technological advancements, regulatory developments, and other opportunities. Enable the group to proactively identify and take advantage of career development opportunities.
• Ensure regular entry of data to support departmental metrics and analytics.
• Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles.
• Serve as process owner, lead, or subject matter expert as needed. Lead the development of training on regulatory documents from a variety of disciplines and provide to writers regardless of reporting relationship in matters pertaining to documentation processes and principles. Lead the development of resources for writing team to ensure quality standards.
• Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
• Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior business performance.
• Represents BMS at industry and professional meetings to maintain knowledge of evolving industry standards and trends.

Reports to the Executive Director, Global Scientific and Regulatory Documentation

Qualifications

• A proven record in managing group/project team with exemplary behaviors in cross-functional collaboration and communication.
• Extensive experience in writing and overseeing high-quality regulatory documentation, including high-level summary documents (preferably clinical).
• Significant experience in managing project teams and process workflows and exhibits solid behaviors in cross-functional collaboration and communication.
• Significant experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success.
• Significant experience in mentoring and professional development of colleagues in a group.
• Advanced understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Demonstrated ability to manage timelines and ensure quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
• Experience in the areas of state-of-the-art documentation processes and technology.

Educational/Experience/Licenses/Certifications:

Masters/PharmD/PhD/MD in a relevant scientific discipline with a minimum of 15 years in pharmaceutical regulatory documentation. Prior regulatory documentation leadership in the development and approval of new drug applications/dossiers is preferred.

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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", 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 a supportive culture, promoting global participation 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 Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.