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Integrated Evidence Generation Lead

  • Mississauga, Canada
  • Project / Product management

Job description

  Job facts

Title: Integrated Evidence Generation Lead

Department: Evidence Generation and Strategic Collaborations

Location: Mississauga Campus

2 Positions Available!

Objective:

The Integrated Evidence Generation Lead is the primary point of contact for EG activities for the squad (therapeutic brand/portfolio), providing Strategic Expertise as well as Operational Oversight.

·  Facilitate identification of evidence gaps and prioritization of which gaps evidence generations projects should be completed
·  Facilitate Canadian input into the global Integrated Evidence Plan; Owner of the local (Canadian) Integrated Evidence Plan (IEP)
·  Provide guidance on best approach to fill local data gaps (Design, Study Classification, Timing, Budget)•Accountable for execution of the local RWD activities occurring within Canada
·  Collaborate with cross functional network – identify data resources, explore local research opportunities
·  Within the local IEP build and oversee the local Publication plan – and work with team to realize all publication opportunities.Collaborate closely with the COL (Clinical Operations Lead) who is providing oversight to the PDG/PDMA/Interventional IIS portfolio

Responsibilities:

Implementation and Management of RWD Studies

·  Develop RWD study protocols and analysis plans
·  Lead the implementation of RWD studies in Canada in collaboration with internal (Biostatistics, Health Economics, Medical Affairs, CCO) and external (therapeutic experts, academic research institutions, private research organizations) partners
·  Perform high quality analyses using appropriate methodologies, tools, and best practices
·  Authors and contributes to internal study reports, peer-reviewed publications and manuscripts, and external presentations

Strategy and Planning

·  Assist in the assessment and evaluation of the internal and external RWD environment in order to help develop and maintain the overall strategy for RWD Sciences in Canada
·  Contributes to strategic alliances between internal and external partners to drive the long-term strategy and direction of RWD Sciences in Canada
·  As an integral member of local cross-functional teams, the RWD Manager is responsible for developing the RWD strategies to meet the evidence needs of internal stakeholders (eg. Product Strategy, Medical Affairs, Regulatory Affairs and Market Access)
·  Contributes the annual Integrated strategic plans (Medical Strategy Plan, Market Access Strategy Plan) as it relates to RWD studies through development and execution of the local Integrated Evidence Generation Plans
·  Collaborates with global teams (Global RWD Science, Pharma Development Medical Affairs, International 8 Network) to ensure strategic alignment between local RWD initiatives and the global organization

Methodological Expertise

·  Serves as the subject matter expert able to consult and advise on RWD methodology used in RWD studies
·  Develop and maintain expertise in the methodologies and study design in the field of RWD Sciences
·  Develop and maintain knowledge of RWD sources and how to effectively access data for RWD studies

Education and Communication

·  Key contributor to internal and external education regarding RWD issues including strategy, awareness, and methodology
·  Support Communication and engagement with external partners (government officials, regulators, payers, and patient groups) to ensure the external environment is and remains to be well-suited for RWD Sciences in Canada

Qualifications:

·  Masters inEpidemiology, Outcomes Research, Statistic, Biostatistics, or similar areas of academic discipline
·  Programming experience with SAS and/or other statistical software packages would be an asset
·  More than 2 years of experience with the following:
·  Intimate knowledge of private and public RWD sources and how to gain access to data
·  Strong understanding of the different types of RWD studies, their benefits and limitations, the impact of their results, and appropriate utilization of RWD study designs
·  Advanced knowledge of RWD analytic methods and best practices for the design and implementation of RWD studies
·  Understanding of the evidence requirements throughout drug development, including regulatory approval and market access
·  Strong strategic ability demonstrated by problem-solving and critical thinking skills, and the ability to drive RWD strategies to support clinical development, and medical and market access activities
·  Strong communications, influencing skills, and collaboration skills demonstrated by effective contribution in cross-functional teams, ability to influence without authority, and the ability to build strong collaborative relationships with internal and external partners
·  Proven project management, planning, and organizational skills demonstrated by the simultaneous management of multiple projects, ability to manage scope, and effective delegation to other functions, staff, contractors, and external vendors

Qualified candidates are encouraged to submit cover letter and resume no later than June 21, 2019.

This position is not eligible for relocation support.

This position is open to applicants legally authorized to work in Canada.

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.

·  Who we are

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an equal opportunity employer.

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