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| Article Listing | Search Articles | More Articles in In House Jobs | More Articles by Alimera Sciences |
VP, General Counsel |
| by Alimera Sciences - 10/07/2018 |
| |
| "Provides overall strategic and operational direction as well as effectuates necessary change to ensure the successful operation of Alimera’s Compliance Program and to foster a culture of compliance within the company." |
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VP, General Counsel
Alimera Sciences - Alpharetta, GA 30005
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Position Summary
Provides overall strategic and operational legal direction as well as effectuates necessary change to ensure the successful operation of Alimera’s Compliance Program. Provides legal advice for a wide variety of regulatory matters, including Fraud and Abuse, OIG Compliance, FDA marketing (advertising, promotion, labeling) and other FDA regulatory (clinical R&D) issues. Reviews and manages legal contract responsibilities in commercial contracts, particularly clinical trial, supply, manufacturing and/or distribution agreements. Provides practical legal advice and support on business matters. Responsible for oversight and leadership in the development, implementation, and ongoing management of the Compliance Program. Evaluates the effectiveness of the Compliance Program to determine if objectives are being met, including the management of the particular risks faced by the company. Coordinates internal compliance activities across all functional teams impacted by the Compliance Program. Monitors the regulatory and enforcement environment to ensure that the Compliance Program continues to meet applicable compliance requirements. Reports directly to the CEO and is a contributing member of the Executive Management Team.
Essential Duties & Responsibilities
Provides overall strategic and operational direction as well as effectuates necessary change to ensure the successful operation of Alimera’s Compliance Program and to foster a culture of compliance within the company.
Leads the development and implementation of the essential elements of an effective compliance program
Chairs the company’s Compliance Committee and provides regular updates to both that Committee and the Board of Directors on the status of the Compliance Program, risks facing the company, and efforts to manage those risks.
Oversees the drafting of policies and procedures to address identified areas of risk and that promote the objectives of the Compliance Program.
Facilitates the delivery of compliance training programs to ensure appropriate socialization of the Compliance Program through the company.
Creates an atmosphere of open communication whereby company personnel are empowered to report suspected violations of company policies and procedures and ask compliance-related questions.
Oversees the monitoring and auditing of company activities to verify compliance with company policies and procedures.
Directs the investigation of instances of suspected non-compliance with company policies and procedures.
Make recommendations for appropriate disciplinary and corrective action upon substantiation of instances of non-compliance.
Responsible for innovation and leadership in identifying and implementing compliance-related company goals and objectives.
Evaluates the results of the Compliance Program to determine if objectives are being met.
Establishes partnerships and collaborative relationships with internal and external stakeholders to foster a culture of compliance and to build personal and company credibility.
Partners with company business units and external partners to increase effectiveness of the Compliance Program.
Maintains and expands support for the Compliance Program at all levels with the company.
Works closely with the CEO, Compliance Committee, and Board of Directors on strategy, solutions, positioning, and other planning activities as necessary to remain abreast of the regulatory/enforcement environment and Compliance Program best practices.
Prepares reports for the Compliance Committee and board of directors or other groups on the status of the Compliance Program and risks faced by the company and strategies for managing that risk.
Provides compliance expertise and leadership within the organization, actively provides input in the assessment of compliance risks and needs to ensure adequate protection of the Company and its employees.
Collaborates with and functions as business partner across the company’s functional areas.
Works closely with the executive team and other company personnel on legal strategy, solutions, planning activities, drafting and negotiation as necessary to support the business.
Drafts, reviews, negotiates and prepares agreements on behalf of the company as necessary to support the business.
Provides legal advice to company personnel on potential litigation and legal matters involving the company and manages litigation and potential litigation respecting the same.
Provides legal advice to the Board of Directors as requested
Reviews and assists with the company’s SEC filings as necessary
Interfaces with Company counsel on legal issues relating to the Company
Operates as a business partner to company personnel, providing legal input on business strategies as necessary. Collaborates with and functions as business partner across the company’s functional areas.
Education & Work Experience
J.D. required and must be admitted to and in good standing with any U.S. Bar Associatio
10 years of experience with increasing levels of responsibility in senior leadership roles within a pharmaceutical or other life sciences company.
Demonstrated knowledge and understanding of the required elements of a corporate compliance program, including the requirements of the Office of Inspector General corporate integrity agreements.
Ability to assess legal and compliance risks faced by a life sciences company and develop strategies for managing that risk. Demonstrated experience drafting and negotiating a wide variety of life sciences related commercial contracts, particularly clinical trial, supply, manufacturing, and/or distribution agreement.
Significant experience with laws, rules, regulations, and guidance documents relating to healthcare fraud and abuse, including the Anti-Kickback Statute, False Claims Act, the Food, Drug and Cosmetic Act, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the PhRMA Code.
In addition, significant experience with SEC reporting requirements, Corporate Governance issues and litigation issues. Demonstrated success in building successful cross-functional relationships to allow the positioning of legal counsel and corporate compliance as business partner within a pharmaceutical or other life sciences company.
Strong project management skills. Excellent planning and organizational skills, time management, communication, decision making and presentation skills.
Work Environment & Physical Demands
General office working conditions which may, at times, be fast paced and stressful. Moderate to extensive travel may be required including international destinations.
Alimera Sciences, Inc. is an equal opportunity employer EEO/AA and strongly supports diversity in the workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, status as a qualified individual with a disability or Vietnam era or other protected veteran. M/F/V/D
Job Type: Full-time
Experience:
corporate compliance: 10 years (Preferred)
legal responsibilities in a pharmaceutical or life sciences: 10 years (Preferred)
12 days ago If you require alternative methods of application or screening, you must approach the employer directly to request this as Indeed is not responsible for the employer's application process.
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| Contact Email: https://alimerasciences.com/about-us/contact-us/ |
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