Senior Specialist, Portfolio & Programs Management (PPM) (Hybrid)
Regulatory Planning & Execution works closely with various stakeholders to drive the identification, planning, resourcing, execution, and management of activities to deliver high quality and timely regulatory and safety submissions. Responsibilities include independent management of all submission projects and documents, at any level of complexity, across all submission types throughout the product lifecycle. The incumbent is expected to be skilled in project management with a demonstrated track record of leadership in a cross-functional setting. Additionally, the incumbent may be involved in leading or supporting internal or external process improvement or strategic initiatives.
The responsibilities of the incumbent may include:
In collaboration with the RPP Regulatory and/or Safety Lead:
Assemble a cross-functional team and drive the identification, planning, and execution of regulatory submissions with an end-to-end mindset.
Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant stakeholders.
Identify, assess, and actively resolve or escalate, where necessary, any risks or issues that could impact the successful execution of submissions.
Actively create and manage timelines including a clear understanding of dependencies and critical path activities.
Ensure project data, including information used to maintain compliance and aid with submission planning, is accurately reported in databases.
For assigned products, works closely with the Regulatory Lead to assess the overall program and manage the sequencing of submissions as needed.
Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables.
Actively lead and/or participate in continuous improvement activities including business processes, tools, systems, metrics, and analytics.
Continuously develop and improve leadership and project management skillsets, understanding of drug/vaccine/biologics/device development, and regulatory practices .
Education Minimum Requirement -
Ability to lead, influence and work effectively in a matrix organization.
Effective at establishing clear goals and assigning responsibility in a team setting.
Effective team facilitation with ability to establish collaborative team environments.
Detail-oriented with the ability to understand the “big picture” and overall strategy of projects/programs
At least 3 years of working experience within a pharmaceutical/healthcare/consumer care industry in a project management/regulatory affair and/or pharmacovigilance/risk management function.
Desired Experience, Education & Skills:
Knowledgeable in the management and successful delivery of regulatory submissions.
Advanced degree preferred (engineering or scientific discipline, MBA).
Technically skilled in project management methodologies (e.g., PMP).
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$97,680.00 - $153,700.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Flexible Work Arrangements:Hybrid
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