Estimating Director leads the estimating function and develops standards, procedures, tools, and methodologies to produce cost estimates for technical projects based on work scope, specifications, and proposal or contract requirements. Establishes processes to perform analysis of project requirements, plans, and specifications to identify labor, material, equipment, and service requirements. Being an Estimating Director incorporates benchmark data, trends, and historical pricing to generate detailed cost estimates that consist of itemized lists of expenses, labor hours, material quantities, and potential cost variations. Develops a workflow and system for scheduling and processing estimate requests and communicating with stakeholders. Additionally, Estimating Director depending on the complexity and type of project, may use different estimating methods, mathematical models, or specialized estimating software tools to generate estimates. Requires a bachelor's degree. Typically reports to senior management. The Estimating Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be an Estimating Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)
This is what you will do:
The Senior Director, Advertising and Promotional Compliance, will direct and conduct the regulatory affairs aspects of review and approval of promotional materials and marketing activities for all products in the Alexion portfolio and pipeline, including acquisition products. This individual will have primary responsibility for strategic planning and preparation of critical submission documentation with business partners and the health authorities ( U.S. Food and Drug Administration (“FDA”)). S/he will lead and direct the Regulatory Affairs Advertising and Promotional Compliance organization in support of the Alexion portfolio, pipeline, and therapeutic areas, and will develop and implement strategies to facilitate the development and review of promotional materials and activities. This position requires that the successful applicant possess expert knowledge of FDA promotional regulations to support assigned therapeutic area(s) (TA) and related business functions. This position will independently work with business senior leaders to provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products. This is a US role with team members based in the US. This is a leadership role in regulatory affairs interacting with commercial, medical and legal on a regular basis with very strong interactions occurring when in launch mode.
You will be responsible for:
Additional representative responsibilities will include, but not necessarily be limited to, the following:
You will need to have:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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