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Compliance Senior Manager, Policies Thousand Oaks United States,  

Amgen (company)

Posted on : 01 May 2017

Project Description

Amgen s Worldwide Compliance and Business Ethics department (WC&BE) consists of a highly qualified and motivated team of professionals who identify, review, evaluate, manage and advise on compliance considerations within the organization. As a member of the Policies, Training, Communications & Business Ethics (PTC&BE) group, the Compliance Senior Manager will be responsible for Global Healthcare Compliance policy development. They will also provide policy advice to strategic initiatives and programmatic improvements to the Global Healthcare Compliance program.

Responsibilities Include:
Based on input from subject matter experts, develop and update global Healthcare Compliance controlled documents, including policies and standard operating procedures (SOPs)

Work in partnership with key internal stakeholders and training professionals to develop and update content for training and job aids, including quick reference guides

Supporting business development opportunities from a compliance perspective, including reviewing compliance-related contract terms and conducting compliance due diligence of specified business development opportunities

Prepare written communications intended for multiple internal stakeholder audiences

Develop and manage project schedules and processes to ensure the project timelines/deadlines are met

Coordinate project team meetings and work in cross-functional teams to ensure execution of initiatives

Assist in management of the execution of global Healthcare Compliance policy and training plans

Provide strategic input into the processes across WC&BE related to the execution of the global Healthcare Compliance program

Maintain knowledge of the healthcare industry, recent federal and state enforcement activities, and the laws and regulations (including the federal and state anti-kickback laws) relating to the development, approval, and commercialization of biopharmaceutical products

Manage relationships with consultants and attorneys

Represent WC&BE on corporate cross-functional committees

Work closely with internal Global Healthcare Compliance Operations to ensure effective implementation of compliance procedures and processes

Basic Qualifications
Doctorate degree and 2 years of Compliance, Audit or Legal experience

Master s degree and 4 years of Compliance, Audit or Legal experience

Bachelor s degree and 6 years of Compliance, Audit or Legal experience

Associate s degree and 10 years of Compliance, Audit or Legal experience

High school diploma / GED and 12 years of Compliance, Audit or Legal experience

Preferred Qualifications
Competency in the area of policy and SOP writing

Knowledge of the healthcare industry, recent federal and state enforcement activities, and the laws and regulations relating to the development, approval, and commercialization of biotechnology/pharmaceutical products

Proven project management ability

Strong attention to detail, organization skills, and the ability to work independently, efficiently, and with minimal supervision

Effective communication, writing and presentation skills

Proficient in MS Word, MS PowerPoint, Outlook and document management systems

Ability to handle ambiguity and complex situations

Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude

Ability to think strategically and to translate strategy into action plans

Ability to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team player

Ability to work with all levels of staff and management, and build relationships across disciplines

Experience in building healthy working relationships across departments, making difficult decisions, solving problems, working under time constraints, presenting to internal peers and external clients, managing numerous projects at once

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.


US, California, Thousand Oaks

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