Address
Form of workThe Position
Genentech, Inc. seeks a Senior Labeling Specialist in its South San Francisco, California location.
Serve as labeling lead in creation of labeling artwork (cartons, container labels, inserts) for timely development, maintenance and revisions of labeling artwork for their assigned products and projects. Provide support for labeling activities along with the generation and revision of printed packaging materials like package inserts, patient information leaflets, Medication Guides, Instructions for Use, Carton, and Container labels. Participate in and/or otherwise support development and implementation of new or updated Product Development Regulatory and/or Commercial Labeling-specific Standard/Department Operating Procedures (SOPs/DOPs), systems, processes, or other relevant tools, including efforts to build greater efficiency into the labeling process. Support new product launch by communicating with stakeholders and obtaining the information to develop the initial artwork for Human Factors or/and a Design Validation study, followed by submission of a biological or new drug or combination product application to the FDA. Support strategic and operational labeling of biologics, pharmaceutical products, and devices. Provide regulatory intelligence necessary to meet FDA and patient requirements for products, which includes all therapeutic areas and all phases of product development from early development to post-marketing. Analyze impact on Genentech's regulatory practices and processes and make recommendations for required changes. Participate in authoring correspondence with the FDA and interpretation of FDA comments, including follow-on correspondence, such as resubmissions, and summary of labeling changes document in Documentum to support the Annual Report submission. Support the artwork related documents for FDA supplement submissions like Prior Approval Supplement (PAS), Changes Being Effected in 30 Days (CBE-30) and Changes Being Effected in 0 Days (CBE-0). Proactively identify compliance issues and support efforts to address and close compliance gaps through research of FDA regulations/guidance, the issue, comparing to previous FDA approved labeling, and recommending a labeling position. Manage cross-functional projects, lead cross-functional teams, and may mentor interns and provide oversight on intern projects. Keep current in the areas of regulatory labeling, pharmaceutical packaging, healthcare compliance, and ethics. Telecommuting is permitted full-time from anywhere in the US.
Education and experience required: Bachelor's degree in Regulatory Affairs or Science, Biotechnology, a Life Science, or a related field, and 5 years of progressive, post-baccalaureate experience as a Regulatory Affairs Associate, Specialist or Lead; Labeling Associate, Specialist or Lead; or related role in the biotechnology or pharmaceutical industry.
Special Requirements: Must have the following skills from academic or industry:
The expected salary range for this position based on the primary location for this position of California $140,400 to $183,200 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Worksite: 1 DNA Way, South San Francisco, California, 94080, United States
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Genentech, Inc. seeks a Senior Labeling Specialist in its South San Francisco, California location.
Serve as labeling lead in creation of labeling artwork (cartons, container labels, inserts) for timely development, maintenance and revisions of labeling artwork for their assigned products and projects. Provide support for labeling activities along with the generation and revision of printed packaging materials like package inserts, patient information leaflets, Medication Guides, Instructions for Use, Carton, and Container labels. Participate in and/or otherwise support development and implementation of new or updated Product Development Regulatory and/or Commercial Labeling-specific Standard/Department Operating Procedures (SOPs/DOPs), systems, processes, or other relevant tools, including efforts to build greater efficiency into the labeling process. Support new product launch by communicating with stakeholders and obtaining the information to develop the initial artwork for Human Factors or/and a Design Validation study, followed by submission of a biological or new drug or combination product application to the FDA. Support strategic and operational labeling of biologics, pharmaceutical products, and devices. Provide regulatory intelligence necessary to meet FDA and patient requirements for products, which includes all therapeutic areas and all phases of product development from early development to post-marketing. Analyze impact on Genentech's regulatory practices and processes and make recommendations for required changes. Participate in authoring correspondence with the FDA and interpretation of FDA comments, including follow-on correspondence, such as resubmissions, and summary of labeling changes document in Documentum to support the Annual Report submission. Support the artwork related documents for FDA supplement submissions like Prior Approval Supplement (PAS), Changes Being Effected in 30 Days (CBE-30) and Changes Being Effected in 0 Days (CBE-0). Proactively identify compliance issues and support efforts to address and close compliance gaps through research of FDA regulations/guidance, the issue, comparing to previous FDA approved labeling, and recommending a labeling position. Manage cross-functional projects, lead cross-functional teams, and may mentor interns and provide oversight on intern projects. Keep current in the areas of regulatory labeling, pharmaceutical packaging, healthcare compliance, and ethics. Telecommuting is permitted full-time from anywhere in the US.
Education and experience required: Bachelor's degree in Regulatory Affairs or Science, Biotechnology, a Life Science, or a related field, and 5 years of progressive, post-baccalaureate experience as a Regulatory Affairs Associate, Specialist or Lead; Labeling Associate, Specialist or Lead; or related role in the biotechnology or pharmaceutical industry.
Special Requirements: Must have the following skills from academic or industry:
- regulatory drug or biologic labeling for prescription products
- regulatory drug or device combination product labeling for commercial purposes
- artwork creation process for prescription products, including Electronic Labeling Management applications and Structured Product Labeling (SPL) publishing software
- applying knowledge of FDA regulations for drugs or biologics, pharmaceutical packaging, healthcare compliance, and regulatory ethics
- stakeholder management
The expected salary range for this position based on the primary location for this position of California $140,400 to $183,200 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Worksite: 1 DNA Way, South San Francisco, California, 94080, United States
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
