Project Manager- Regulatory

Canada, Ontario, Mississauga

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Project Manager

Department: Pharma Technical Regulatory (PTR)

Duration: 2-year contract

Location: Mississauga

GENERAL POSITION SUMMARY

The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams (TRTs) in managing programs efficiently and effectively and in executing regulatory activities. This role will be involved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Project and Portfolio Management Group (PPM).  The Product Project Manager is an advocate of PPM, utilizing best practice methodologies to support TRTs and portfolio managers in providing clear communications for assessment and trending of the PTR portfolio. This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Technical Development Teams, Technical Product Teams, PPM and other program stakeholder to ensure visibility to TRT operations and cross-functional alignment of TRT strategy.

Primary duties and responsibilities

  • Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, small molecules, devices, antibody drug conjugates.   Be a thought partner to TRLs and team members, facilitate and drive team discussions based on high-level program knowledge.
  • Provide project management support to TRTs at any stage of the drug development lifecycle (i.e. early or late stage development, marketing authorization or post-launch marketed phases).  Provide support of PTR Strategic Focus Areas and cross-organizational initiatives
  • Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
  • Partner with TRLs and teams, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
  • Execute project management activities to support products for global market applications and product life-cycle activities.
  • Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platforms.
  • Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
  • Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
  • Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times.
  • Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
  • Proactively monitor timelines, submission process KPIs, critical path and resources for assigned products using appropriate tools, project management principles and practices. Monitor timeline deviations from baseline and KPIs and closely collaborate with TRLs and Submissions Leads to keep submissions on track.  Assist with driving data compliance and accuracy across the organization.

Competencies

  • Demonstrates, or has proven abilities to demonstrate PTR and Roche Core Competencies.
  • Strong influencing, organizational and interpersonal skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, and relationships.
  • Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers and stakeholders.
  • Understands key change management concepts and methodologies.
  • Must work well as member of a diverse global team and in a proactive, positive and collaborative manner; Ability to manage cross-functional teams.
  • Outstanding project management, planning, organization, prioritization and time management skills. Can effectively and efficiently manage and complete multiple, large-scale and complex priorities and projects on-time and on-target.
  • Able to deal with ambiguity and constant change.
  • Able to work independently with minimal supervision.
  • Able to function effectively and in an agile manner in a fast-paced, multi-tasking environment.
  • High level knowledge of regulatory requirements, manufacturing or technical development processes.
  • Highly Competent in MS office applications including Excel, PowerPoint, Word, Project and Smartsheet or other PM tools.

Education & Experience

  • BA/BS or MS in Scientific, Technical, Engineering or Business discipline. Advanced degree preferred.
  • A minimum of 8-10 years’ total work experience with at least 5 or more years’ relevant experience in project management within the pharmaceutical/biotech/medical device industry with a sound knowledge of drug development processes.
  • Project, Program, or Portfolio Management certification is preferred but not required. Knowledge of Project Management methodologies, concepts, techniques and tools is required.
  • Prior experience with programs and portfolios in a strategic context is a plus.
  • Prior regulatory experience preferred.
  • Six Sigma or other OE-related certifications a plus.

TRAVEL REQUIREMENTS

  • Ability to travel up to 20%

Have we sparked your interest? We then encourage you to submit a cover letter and resume no later than June 21, 2021.

This position is not eligible for relocation support.

Note: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks. Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process.

Agency notice: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency