Principal Compliance Analyst

PDL BioPharma is a leader in the discovery, development, and marketing of innovative therapies for acute-care environments. Our current product pipeline includes six breakthrough investigational compounds for the treatment of cardiovascular disorders, cancer, and other serious illnesses.

Pioneering science, strong commercial products, and a rich development pipeline define PDL BioPharma. And our success is based on one key factor—our people. At PDL BioPharma, every employee directly contributes to the development and delivery of innovative therapies that help make real a difference in people's lives. We foster a goal-oriented and entrepreneurial culture where teamwork, commitment, and initiative are valued and rewarded.

Products. Pipeline. People. PDL BioPharma invites you to be part of the future of biotechnology.

We are proud to be an equal opportunity employer.



Job Description
The Principal Compliance Analyst, reporting to the Sr. Director of Compliance, will be responsible for ensuring the establishment, maintenance and effectiveness of PDL's Compliance programs at the company's sites worldwide. This individual will be responsible for planning, implementation and maintenance of the Company's compliance programs. The individual will establish departmental metrics to ensure effective goal achievement, and alignment with corporate objectives. In addition, they will work with leaders of all regulated departments including Regulatory Affairs, Quality, Manufacturing, Clinical, Finance, Sales and Marketing, Human Resources, Environmental Health and Safety and Research and Development in all aspects relating to the assurance of compliance in the corporation.

The Principal Compliance Analyst will be an active participant in planning and program management to ensure that appropriate compliance standards are built into Company operations. The Principal Compliance Analyst will be a key staff member of the Company Compliance department. The individual's reports and conclusions will be reviewed by the Executive Team and the Board Compliance Committee and the input of this individual will have high visibility within the corporation.



Required Skills
Priorities include:
-Development and implementation of a rugged compliance program including development of policies, training, monitoring and surveillance programs. -Reviewing and improving operational efficiencies in compliance in all functional areas.
-Working with other members of PDL's management process. -Integrating new regulations and acquisitions into the compliance management system.
Requirements: -M.S. or B.S. in a technical discipline -A minimum of 10 years of experience in the regulated industries is required. -A strong working knowledge of USA and other ex-USA regulatory and compliance requirements, as well as standard compliance management tools and standards. -Practical knowledge and sound understanding of business processes.