Content Standards & Governance Lead

United States of America, California, South San Francisco
Switzerland, Basel-City, Basel
Canada, Ontario, Mississauga
United Kingdom, Hertfordshire, Welwyn

de fr es ru tr it pt zh ja

Summary

  • 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

Job Responsibilities

  • 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.

Content Management & Governance -Specific Responsibilities:

  • 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

External Customers

  • Project Leaders/Managers, Global Process Owners, Domain Stakeholder / Subject Matter Expert Team, System Owners, Information Architects
  • Content Owners, Content Operations Managers, Report Owners, Functional Leadership and Governance Teams, Cross-Functional Content Governance Offices
  • Business Leaders, Global Information Standards Governance Committee, Functional Leadership and Governance Teams, Compliance/Regulatory Experts

Job Requirements and Competencies

Required

  • 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

Preferred

  • 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.

Roche is an equal opportunity employer.

Research & Development, Research & Development > Biometrics