28 days old

Strategic Planning and Operations - Senior Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117523691
Amgen

Job ID: R-92405
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Strategic Planning and Operations Senior Manager (SP&O) for Global Regulatory Affairs. This position reports directly to the Vice President of Global Regulatory Affairs and will be located in Thousand Oaks, California.

The SP&O serves as a critical thought-partner for the Department VP to develop and execution on department goals and initiatives. The SP&O works closely with Finance, HR, and other cross-functional collaborators to ensure the Global Regulatory Affairs team has the resources it needs to successfully meet its objective of providing "best-in-class global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules."

Primary responsibilities:
  • Defining strategic and operational goals for the department, and tracking progress against those goals
  • Identifying opportunities for improvement (e.g., processes, resourcing, communications) and driving the implementation of chosen solutions
  • Developing and maintaining business relationships cross-functionally across R&D and into other Amgen functions
  • Representing the Department on process improvement initiatives


Key Activities
  • Facilitate department goal setting and initiatives and track deliverables
  • Manage the Department's Senior Management Team (SMT) meetings
  • Facilitate and manage the Global Regulatory Advisory Committee (GRAC Meetings)
  • Act as a sounding board/advisor to the VP on key activities and issues
  • Proactively identify and resolve upcoming issues within the Department, and at interfaces with other departments
  • Drive and manage the health of the Global Regulatory Teams (GRTs) by managing the GRT Project Coordinator, facilitating the GRT Survey, and driving initiatives to support increased team effectiveness across the GRTs
  • Develop and/or drive execution of VP communication plan
  • Prepare internal presentations including All-Staff presentations, reports on business performance, etc.
  • Represent the goals for the department and partner with other functions such as Human Resources and Finance in support of Departmental objectives
  • Work with VP to organize staff meetings to achieve objectives of the organization
  • Identify and lead or contribute to initiatives/process improvement opportunities as designated by VP
  • Assist in interactions at senior level forums as needed
  • Manage and execute other assigned tasks upon request of VP


Knowledge
  • Pharma/Biotech industry knowledge with focus on Regulatory Affairs
  • Knowledge of Good X Practices (e.g., GCP, GMP, etc.), FDA and international regulations and guidelines, as applicable
  • Knowledge of biopharmaceutical compliance
  • Knowledge/ability to influence and lead without direct line authority
  • Extensive project management/project planning experience overseeing program deliverables, budgets, and timelines
  • Experience writing and presenting clearly to Senior Management audience
  • Experience leading teams in a matrix environment


Basic Qualifications

Doctorate degree & 2 years of experience in life sciences, biotech or the pharmaceutical industry

OR

Master's degree & 6 years of experience in life sciences, biotech or the pharmaceutical industry

OR

Bachelor's degree or & 8 years of experience in life sciences, biotech or the pharmaceutical industry

OR

Associate degree & 10 years of experience in life sciences, biotech or the pharmaceutical industry

OR

High school diploma / GED & 12 years of experience in life sciences, biotech or the pharmaceutical industry

Preferred Qualifications
  • MBA., PhD, PharmD, Master's Degree
  • Regulatory Affairs Experience
  • 10 years' work experience in life sciences or medically related field, including 7 years of research and development experience in biopharmaceutical or pharmaceutical industry


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

PI117523691

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92405<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Strategic Planning and Operations Senior Manager (SP&O) for Global Regulatory Affairs. This position reports directly to the Vice President of Global Regulatory Affairs and will be located in Thousand Oaks, California.<br><br>The SP&O serves as a critical thought-partner for the Department VP to develop and execution on department goals and initiatives. The SP&O works closely with Finance, HR, and other cross-functional collaborators to ensure the Global Regulatory Affairs team has the resources it needs to successfully meet its objective of providing "best-in-class global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules."<br><br><b>Primary responsibilities</b>:<br><ul><li>Defining strategic and operational goals for the department, and tracking progress against those goals</li><li>Identifying opportunities for improvement (e.g., processes, resourcing, communications) and driving the implementation of chosen solutions</li><li>Developing and maintaining business relationships cross-functionally across R&D and into other Amgen functions</li><li>Representing the Department on process improvement initiatives</li></ul><br><br><b>Key Activities</b><br><ul><li>Facilitate department goal setting and initiatives and track deliverables</li><li>Manage the Department's Senior Management Team (SMT) meetings</li><li>Facilitate and manage the Global Regulatory Advisory Committee (GRAC Meetings)</li><li>Act as a sounding board/advisor to the VP on key activities and issues</li><li>Proactively identify and resolve upcoming issues within the Department, and at interfaces with other departments</li><li>Drive and manage the health of the Global Regulatory Teams (GRTs) by managing the GRT Project Coordinator, facilitating the GRT Survey, and driving initiatives to support increased team effectiveness across the GRTs</li><li>Develop and/or drive execution of VP communication plan</li><li>Prepare internal presentations including All-Staff presentations, reports on business performance, etc.</li><li>Represent the goals for the department and partner with other functions such as Human Resources and Finance in support of Departmental objectives</li><li>Work with VP to organize staff meetings to achieve objectives of the organization</li><li>Identify and lead or contribute to initiatives/process improvement opportunities as designated by VP</li><li>Assist in interactions at senior level forums as needed</li><li>Manage and execute other assigned tasks upon request of VP</li></ul><br><br><b>Knowledge</b><br><ul><li>Pharma/Biotech industry knowledge with focus on Regulatory Affairs</li><li>Knowledge of Good X Practices (e.g., GCP, GMP, etc.), FDA and international regulations and guidelines, as applicable</li><li>Knowledge of biopharmaceutical compliance</li><li>Knowledge/ability to influence and lead without direct line authority</li><li>Extensive project management/project planning experience overseeing program deliverables, budgets, and timelines</li><li>Experience writing and presenting clearly to Senior Management audience</li><li>Experience leading teams in a matrix environment</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree & 2 years of experience in life sciences, biotech or the pharmaceutical industry<br><br>OR<br><br>Master's degree & 6 years of experience in life sciences, biotech or the pharmaceutical industry<br><br>OR<br><br>Bachelor's degree or & 8 years of experience in life sciences, biotech or the pharmaceutical industry<br><br>OR<br><br>Associate degree & 10 years of experience in life sciences, biotech or the pharmaceutical industry<br><br>OR<br><br>High school diploma / GED & 12 years of experience in life sciences, biotech or the pharmaceutical industry<br><br><b>Preferred Qualifications </b><br><ul><li>MBA., PhD, PharmD, Master's Degree</li><li>Regulatory Affairs Experience</li><li>10 years' work experience in life sciences or medically related field, including 7 years of research and development experience in biopharmaceutical or pharmaceutical industry</li></ul><br><br>Join Us<br><br>If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.<br><br>Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.<br><br>As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/5DOWLrIjOEL1t8O6CpWBQ"> <p>PI117523691</p>

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Posted: 2020-01-28 Expires: 2020-02-28

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Strategic Planning and Operations - Senior Manager

Amgen
Thousand Oaks, CA 91360

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