Seagen
Senior Manager Regulatory CMC Writer
Development - Bothell, United States
Description
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary:
The Sr. Manager, Reg CMC Writing is a people manager role that is responsible for managing the Reg CMC Writing team (employees and contractors), authoring and revising regulatory documents for submission to the FDA and other agencies in collaboration with subject matter experts and the Reg CMC strategists, and leading continuous improvement of submission-related business processes.
Principal Responsibilities:
- Recruit, onboard, develop, and oversee diverse talent to support Seagen’s evolution and growth
- Continuously improve, evolve, and implement the Quality submission-related business practices and tools across Reg CMC while collaborating with Medical Writing
- Forecast and distribute Reg Writing support to the Reg CMC product teams; identify and communicate resource needs
- Closely interact with Reg CMC Product/Strategy Leads and Technical Operations subject matter experts to develop Quality sections of regulatory submissions, briefing documents, information request responses, Quality summaries, redlines, redactions and additional documents intended for submission to global health authorities
- Facilitate comment adjudication meetings and issue resolution during document review cycles
- Remain current on relevant Regulatory Intelligence/Industry standards in order to advise Reg CMC department and submission working groups on current best practices and future trends for presentation of Quality information in regulatory submissions
- Ensure accuracy and timeliness of regulatory information uploads by the Reg CMC Writing group to the RIM system.
- Interface with Regulatory Operations and Regulatory Project Management to efficiently QC submission documentation, communicate forecasts and provide periodic reporting on regulatory submissions
- Liaise with the Quality, Development, IT, Technical Operations, External Partners and Contract Manufacturing organizations regarding data integrity practices and documentation exchange to support regulatory submissions
- Other duties as assigned
Required Qualifications:
- Demonstrates proficiency (teaches others, makes improvements) of key areas of responsibility, which is typically associated with a bachelor’s degree in a related field, 5+ years of experience in the biopharmaceutical industry, 3+ years of direct Reg CMC writing experience, and 1+ years of supervisory experience
- Expert in MS Word
- Proficient in:
- Regulatory submission requirements (content, structure, format, data integrity) for FDA, EMA, HC, PMDA
- Knowledge of cGMP
- Adobe Acrobat
- Excel
- Veeva Vault RIM
- Demonstrated ability to:
- Hold self and others accountable to meet commitments
- Develop and deliver multi-mode communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences.
- Engage, inspire and develop direct reports; build a sense of community in the larger organization
- Handle conflict situations effectively
- Build partnerships and work collaboratively with others to meet shared objectives.
- Step up to address difficult issues, saying what needs to be said
- Provide direction, delegate, and remove obstacles to get work done
- Create a climate where people are motivated to do their best to help the organization achieve its objectives
Preferred Qualifications:
- Masters or doctorate degree in life sciences
- Skilled in Excel, and PowerPoint; experience with Adobe Acrobat
- Understanding of Publishing/Reg Ops and Submission Management, Veeva Systems
- Awareness of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process
- Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment with limited supervision
- Experience in the Biopharmaceutical industry
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
The hiring pay range for this position is $135,000 - $175,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 09/08/2023
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