The content standards & governance lead is accountable for the end-to-end management of content standards process including requests, definition, and adoption for all Category and Document Level Information Products (Clinical and Non Clinical Documents).
Drives and facilitates organization-wide content standardization, re-use and standardization strategy; is the final decision maker on matters of strategy
Content Standards & Governance is a global team accountable and responsible for driving the adoption of industry-aligned content standards across all Roche-sponsored clinical trials.
Serve as a first line manager up to 5-6 individual contributors located at sites within the region.
Partner closely with local HR colleagues to ensure individual contributors are being fairly compensated in line with local conditions, assessed for promotion on a periodic basis, and overall are being provided with the best possible working environment in which to thrive.
Foster a healthy team environment both within the region and as part of the global team. Play a key role in stakeholder management both within region and globally.
Partners with key leaders and SMEs to deliver on content standards.Oversee and contribute to activities related to the design, management and governance of content standards from protocol development to regulatory submission aligned with industry standards. Ensure robust processes are in place to maintain content in a metadata repository and ensure it continuously reflects latest approved global content standards.
Contribute to the overall Content Reuse & Automation Office and Content Management & Governance strategy and ensure successful global & regional implementation.
Manage the definition of content standards ensuring appropriate stakeholder involvement across the business, incorporating related industry and regulatory standards/requirements.
Steward existing standards ensuring they are current, approved and aligned with business sponsors meeting end-to-end business needs and promoting content reuse and data alignment.
Educate and oversees appropriate awareness of those that use the standard such as content owners, process owners and stakeholders on the correct application of the standards
Final decision maker for content standards and their application
Oversee reference and master content management through applications like SCM, ACG etc.
Manage metadata repository in Collibra and glossary content for their domain in our defined standards repositories (might include Structured Content Management(SCM), AutoContent Generation(ACG), and other standards repositories as well)
Periodic review and update of existing standards to ensure relevance and meet current requirements
Build and coach a team content standards development core team and their activities
Manage their domain stakeholder/SME teams and the stakeholder’s communities ensuring cross-functional engagement in the standards process. Monitor ongoing content fidelity (e.g. quality, consistency, adoption) levels and other metrics which assess the adherence of content, reuse strategies, and related governance policies/Standards
Work within and beyond their immediate area to implement change in support of the adoption of content governance policies and standards
Facilitates compliance to external content regulations including ICH, Transcelerate, CDISC, CFR Part 11, HIPAA, etc. and internal quality, regulatory and audit requirements
Project Leaders/Managers, Global Process Owners, Domain Stakeholder / Subject Matter Expert Team, System Owners, Information Architects
Business Leaders, Global Information Standards Governance Committee, Functional Leadership and Governance Teams, Compliance/Regulatory Experts
Job Requirements and Competencies
Bachelor's degree in computer science, analytics or science-related field or regulatory (Masters degree preferred)
Significant pharmaceutical industry experience, specifically in drug development (Regulatory submissions, Study Management, Stats,Med Affairs, Drug Safety, Quality, etc.)and/or related business processes
Proven functional expertise sufficient to coach, guide and where necessary problem solve, as well as do direct functional work as required
Customer focus with an emphasis on delivering quality product to agreed timelines
Proven leadership or management ability, ideally associated with previous management experience or experience with mentoring, coaching and
development activities for staff
Proven ability to work effectively in a matrix environment
Good stakeholder management skills – able to understand customer needs, negotiate and agree delivery standards and expectations
Demonstrated consensus building and conflict management skills
High ability to work across multiple cultures and countriesExperience in Clinical Development
Knowledge of data & content integration strategies
Knowledge of Structured Content Management Systems
Knowledge of Auto Content Generation and Natural Language Generation as it applies to Structured Content Design
Knowledge of content modeling and reuse strategies/architecture principles and techniques
Demonstrated/Hands On Experience in standards development & maintenance
Exposure/Working Knowledge of technology development and deployment processes
People management experience
Demonstrated delivery using agile/waterfall methodologies, etc.
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
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.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.