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Employment Opportunities

BioDelivery Sciences International, Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. EEO IS THE LAW

 

BDSI invites any employee and/or applicant to review the Company’s Affirmative Action Plan.  This plan is available for inspection upon request by emailing mbrown@bdsi.com.  If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Michelle Brown at 919-582-9059.

 


 

General Counsel

 

Job Title: General Counsel

Location: Raleigh, NC

Reports To: President & CEO

Education: Bachelor’s degree and Law degree from an accredited Law School. Scientific degree in the Company’s discipline and Patent and Trademark Registration and/or an advanced law degree considered a plus.

 

Requirements

Minimum of 10 years of industry experience. Excellent written and verbal communication skills. Able to handle conflict and deal with multiple issues simultaneously. Background and experience in Intellectual Property important.

 

Summary

The position has responsibility for all legal matters of the Company not directly handled by the CEO or CFO in conjunction with external counsel. The position is also expected to render all decisions considering both the legal and business impact. The General Counsel will be responsible for all matters relating to BDSI’s intellectual property; the creation and maintenance of the company’s contracts as well as managing and advising on all of the company’s insurance policies. The position is also responsible for creating and managing a budget while working concurrently with the various outside counsels supporting the intellectual property, contracts and SEC filings. The General Counsel will also participate as appropriate from time to time in business development activities and in partnership meetings and discussions. Also as the company’s Commercial Compliance Officer the position will oversee the commercial compliance program and work to ensure that the Company and its subsidiaries conduct their commercial activities and business in compliance with all applicable laws and regulations globally.

 

Planning/Implementation

Handles all Company legal matters on a daily basis. Additionally, position requires the necessary business acumen to independently handle issues and make judgments on tasks and assignments made by the CEO. Must understand and prioritize issues such that mission critical work is handled in a timely manner.

 

Analysis

Able to, with confidentiality, review issues and information with the Company’s best legal and business interests in mind. Able to provide options to the CEO considering the necessary legal, business and financial implications.

 



 

Vice President, Regulatory Affairs

 

Job Title: Vice President, Regulatory Affairs

Location: Raleigh, NC

Reports To: Executive Vice President, Product Development

Education: PhD, RAC

 

Requirements

 A minimum of 5 years of industry-related experience in regulatory affairs

 

Duties

This position has responsibility for all aspects of regulatory affairs and compliance including strategy.

 

Planning

Responsible for development and execution of the company’s regulatory strategy

 

Implementation

Manage regulatory affairs and compliance staff, contracts and all regulatory affairs activities including the preparation and maintenance of clinical trial and marketing applications, and the regulatory archive.

Create and maintain company policies and procedures detailing regulatory processes.

 

Analysis

Keep abreast of changes in the regulatory environment impacting the company’s operations, interpret impact, and plan accordingly

 

Reporting

Ensure that all clinical, nonclinical, and chemistry submission documents are reviewed for regulatory suitability and compliance.

 

Communication

Lead all communications with the United States Food and Drug Administration and other regulatory authorities.

Maintain a high profile in the regulatory community.

 

Other

Duties as may be assigned.

 


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