25 days old

Compliance Counsel

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    117422275
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

Provides legal and compliance expertise and counsel for all ACADIA promotional and medical affairs materials and activities. Legal representative on the Legal, Medical and Regulatory committee (MLR). Provides advice, reviews and approves all internal and external promotional and medical materials. Ensures all materials are developed in accordance with Company standards and all applicable laws and regulations. Provides support to the VP, Chief Compliance Officer with respect to companys promotional and medical affairs activities, other compliance activities and support of internal and external investigations as needed. Works closely with Compliance and Legal colleagues. May interact with government agencies, law firms, trade organizations and other external agencies.

Primary Responsibilities:

  • Legal representative of MLR committee. Provides timely legal review of all materials submitted for Medical/Regulatory/Legal (MLR) Review. Works closely with Commercial, Medical and Regulatory Affairs colleagues.
  • Provides legal advice and counseling on various issues, including but not limited to Food & Drug Administration (FDA) labeling, marketing strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, patient support programs, customer interactions, healthcare professional (HCP) engagements, and commercial sponsorships.
  • Proactively identifies risks, opportunities and mitigating actions, and collaborates across business functions to implement.
  • Works closely with leadership from line of business in developing strategy and achieving objectives.
  • Partners with the Chief Compliance Officer to implement an effective ethics and compliance program.
  • Stays informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed.
  • Performs other duties as needed or assigned.

Education/Experience/Skills:

  • Juris Doctorate Degree ABA accredited law school and must be active member of the California or New Jersey State Bars or qualified as Registered In-house Counsel in either State.
  • Minimum of 6+ years of relevant legal experience required.
  • Experience within the healthcare/pharmaceutical industry is required.
  • Litigation or Government Investigation experience is preferred.
  • Deep understanding of the pharmaceutical industry and eventually ACADIA product(s) and business model.
  • Strong problem-solving skills - demonstrates and exercises creativity and initiative.
  • Ability to gain trust at, and work with, all levels of organization.
  • High level of integrity with the ability to maintain the protection of proprietary and confidential information.
  • Strong written and verbal communications skills - able to effectively collaborate and communicate with client groups, senior management and executives within the company.
  • Ability to handle multiple projects simultaneously independently.

Scope:

Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the Company.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.


PI117422275

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>Provides legal and compliance expertise and counsel for all ACADIA promotional and medical affairs materials and activities. Legal representative on the Legal, Medical and Regulatory committee (MLR). Provides advice, reviews and approves all internal and external promotional and medical materials. Ensures all materials are developed in accordance with Company standards and all applicable laws and regulations. Provides support to the VP, Chief Compliance Officer with respect to companys promotional and medical affairs activities, other compliance activities and support of internal and external investigations as needed. Works closely with Compliance and Legal colleagues. May interact with government agencies, law firms, trade organizations and other external agencies.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Legal representative of MLR committee. Provides timely legal review of all materials submitted for Medical/Regulatory/Legal (MLR) Review. Works closely with Commercial, Medical and Regulatory Affairs colleagues.</li> <li>Provides legal advice and counseling on various issues, including but not limited to Food & Drug Administration (FDA) labeling, marketing strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, patient support programs, customer interactions, healthcare professional (HCP) engagements, and commercial sponsorships.</li> <li>Proactively identifies risks, opportunities and mitigating actions, and collaborates across business functions to implement.</li> <li>Works closely with leadership from line of business in developing strategy and achieving objectives.</li> <li>Partners with the Chief Compliance Officer to implement an effective ethics and compliance program.</li> <li>Stays informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed.</li> <li>Performs other duties as needed or assigned.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>Juris Doctorate Degree ABA accredited law school and must be active member of the California or New Jersey State Bars or qualified as Registered In-house Counsel in either State.</li> <li>Minimum of 6+ years of relevant legal experience required.</li> <li>Experience within the healthcare/pharmaceutical industry is required.</li> <li>Litigation or Government Investigation experience is preferred.</li> <li>Deep understanding of the pharmaceutical industry and eventually ACADIA product(s) and business model.</li> <li>Strong problem-solving skills - demonstrates and exercises creativity and initiative.</li> <li>Ability to gain trust at, and work with, all levels of organization.</li> </ul> <ul> <li>High level of integrity with the ability to maintain the protection of proprietary and confidential information.</li> <li>Strong written and verbal communications skills - able to effectively collaborate and communicate with client groups, senior management and executives within the company.</li> <li>Ability to handle multiple projects simultaneously independently.</li> </ul> <p> <strong><u>Scope:</u></strong></p> <p>Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the Company.</p> <p> </p> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/2Vlp6ruW8xjMSZVPFDbQ6"> <p>PI117422275</p>

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Posted: 2020-01-24 Expires: 2020-02-24

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Compliance Counsel

ACADIA Pharmaceuticals
San Diego, CA 92101

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