Senior Regulatory Documentation Team Lead

United States of America, California, South San Francisco
Canada, Ontario, Mississauga

de fr es ru tr it pt zh ja

Position Purpose:

Regulatory Documentation (PDRD) is part of the PD Regulatory organization. PDRD interprets the needs of worldwide health authorities, defining and executing the content and documentation strategy to support development and maintenance of global licenses. PDRD leads documentation deliverables across all therapeutic areas and phases of product development, from entry in to human to product divestiture.

Leading a local or global team of Clinical Project Managers (CPM) and/or Regulatory Documentation Scientists (RDSes), the Senior Regulatory Documentation Team Lead (Sr. RDTL) provides strategic oversight, leadership, management, coaching, and functional expertise to their direct reports, thus ensuring delivery of regulatory documents for assigned molecules, documents assigned to their direct reports, and/or other functional projects.

The Sr. RDTL supports CPMs and RDSes in defining the content and documentation strategy for molecular programs, and oversees delivery of documents and filings by Regulatory Documentation Teams. This includes oversight of the documentation strategy and review of documents in support of molecular programs.

Partnering with stakeholders and business leaders across functions, the Sr. RDTL is accountable for timely delivery of high-quality, compliant regulatory documents.

The Sr. RDTL engages in Site Leadership activities to protect site culture and overall engagement. May also work on complex projects to support and coordinate assigned deliverables, and to guide the efforts of multiple staff members.

The Sr. RDTL will represent and advocate for the department in key internal and external meetings, through various communications channels, or in other ways.

May lead or be a key contributor to complex PDR or cross functional initiatives. Serves as a subject matter expert representing the Product Development Regulatory Documentation (PDRD) group.

May serve as a delegate for Global Portfolio Head.

Is recognized as a leader amongst RDTL peers and a role model in feedback and learning and change management competencies.

Major Responsibilities and Accountabilities:

People Leadership, Management and Development

  • Leads a global/local team of Clinical Project Managers (CPMs) and/or Regulatory Documentation Scientists (Regulatory Documentation Team) in support of multiple products within a single therapeutic area or cluster of therapeutic areas.
  • Acts as a key strategic thought partners for clinical scientists and other team members on the development and writing/editing Protocols, Protocol Amendments and Informed Consent Forms (ICF).
  • Leads medical writing and editing for Late Stage Clinical Development programs by partnering closely with cross-functional stakeholders.
  • Leads the group responsible for the development and collaborative authoring/editing of protocols including drafting/editing, coordination of review and adjudication process and project management aspects such as timelines.
  • Provides Line Management, direction, and leadership to Regulatory Documentation Scientists in order to maximize their capability to produce high-quality regulatory documents for their projects. Actively develops employees for advancement and succession planning through appropriate delegation and identifying opportunities outside of immediate sphere of control.
  • Leads or drives knowledge sharing activities with their direct reports and the broader department and outside of PDRD.
  • Identifies resource needs and recruits, trains and develops appropriate talent, ensuring ongoing compliance with Company and regulatory standards.
  • Plans the resource requirements, skillset and interactions needed to deliver or execute documents
  • Responsible for scheduling and assigning documents and projects to CPMs/RDSes, working collaboratively within PDRD for internal and external resource planning. Takes a portfolio rather than a project level view (not just focused on own team) when resource planning in collaboration with the Central Resourcing Team.
  • Conducts ongoing performance management dialogue and completes the required steps of the performance management cycle. Proactively manages performance issues and conducts individual development/career discussions.
  • Actively contributes to or leads the performance calibration, talent management, and succession planning process.
  • Leads by example and creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels (local, global, functional, projects/programs). Is seen as a role model for leadership.
  • Leads internal/external complex initiatives to influence the current and future ways of working cross functionally at Roche.
  • Accountable for the approval of all functional and project spend of their employees (as appropriate by site).

Global Functional Expertise

  •  A collaborative leadership style is essential.
  • Experience participating in global teams and proven cross-functional stakeholder management experience.
  • Previous experience leading direct or matrix teams required and global experience preferred.
  • Therapeutic area expertise an asset; comprehensive understanding of product and safety profiles; familiar with competitive activity in the field and proactively shares and escalates relevant information.
  • Strong Ability to independently analyze and synthesize data from a broad range of disciplines
  • Builds diverse teams, clearly conveys objectives and expectations pulling people together around a common goal
  • Strong ability to inspire and promote a positive, collaborative work environment; recognizes individuals/teams for progress and risk-taking.
  • Demonstrated coaching and mentoring proficiency at different skill levels.
  • Articulates wise long-term objectives and strategies and focuses on a few key priorities
  • Effectively leads and manages change; successfully adapts to a constantly changing work environment.
  • As appropriate, develops or supports the development of resource plans for the Regulatory Documentation Team.
  • Manages relationships with key stakeholders for the Regulatory Documentation Team and PDRD as a whole.
  • Leads initiatives or process changes and/or harmonization within Roche or with external organizations and professional societies.
  • As needed, may take on regulatory documentation responsibilities within the Regulatory Documentation Team.
  • Identifies, advocates and helps progress new ideas that add business value

Direct Reports - Yes

Professional and Technical Requirements

Qualifications

Ten or more years experience in the pharmaceutical/biotech industry

Demonstrated leadership experience with direct reports or in a matrix environment required.

Bachelor’s degree or equivalent.

Advanced degree in life sciences or other relevant field preferred.

Experience, Knowledge, Skills

  • Demonstrated coaching and mentoring proficiency at different skill levels. Previous experience as a manager strongly preferred.
  • Demonstrated clear, high-quality scientific writing style in the English language
  • Experience developing/writing clinical protocols strongly preferred.
  • Extensive experience in regulatory affairs or related function in drug development and knowledge of international regulations.
  • Experience and expertise leading the preparation of complex filings and/or suites of regulatory documents and/or content.
  • Therapeutic area expertise an asset; comprehensive understanding of product and safety profiles; familiar with competitive activity in the field.
  • Experience participating in global teams and proven cross-functional stakeholder management experience. Previous experience leading matrix teams preferred
  • Ability to independently analyze and synthesize data from a broad range of disciplines
  • Project management skills: consistently achieves multiple tasks and goals on-time
  • Strong communication skills: listens well and encourages direct and open discussion about important issues
  • Builds diverse teams, clearly conveys objectives and expectations pulling people together around a common goal
  • Ability to inspire and promote a positive, collaborative work environment
  • Effective decision-making: delegates appropriately, shows good judgment
  • Articulates wise long-term objectives and focuses on a few key priorities
  • Effectively leads and manages change
  • Identifies, advocates and helps progress new ideas that add business value

Other:

Locations limited to SSF and Mississauga offices. Will consider remote working arrangement if previously shown to be successful and willingness for regular travel to worksites. Occasional overseas travel may be required. Travel >20% (unless remote working arrangement, then higher)

#LI-PDAB1

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs