Manager, Compliance

Location
Emeryville, CA, United States
Posted
Mar 14, 2021
Ref
1063
Hotbed
Biotech Bay
Required Education
Other
Position Type
Contract
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION:

This is a 1+ year contract position. The Manager, Legal & Compliance provides oversite and management of compliance policies, record-keeping/documentation, document approval and training support relating to Santen North America healthcare compliance program. The Manager is responsible for a variety of healthcare compliance-related activities including, but not limited, to support for compliance training and activities; work on drafting, updating, and implementation of compliance policies; support for compliance projects; and other activities as needed to ensure that Santen follows all applicable laws, regulations, and rules pertaining to compliance. This position reports to Associate Director, Compliance.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Health Care Professional (HCP) interactions: Reviewing proposed HCP engagement arrangements, approving remuneration to be paid to HCPs based on properly assigned tiers for them, reviewing and drafting HCP consulting/honorarium agreements in cooperation with colleagues in charge of contracts, providing guidance accommodations provided to HCPs.
  • Medical Communication:Reviewingmedical information / communication materials including external publication and internal training materials and making improvement suggestions to ensure compliance.
  • Marketing Communication: Reviewing marketing strategies, and product-related or other promotional communications.
  • Grants and Donations: Reviewing grants and donations requests such as medical education grants, IST grants and travel grants, including sitting in grants/donation committee as a legal representative; advising on grant/donation review procedures
  • Transparency Reporting: Being abreast of and analyzing all transparency requirements; establish, with external supports as needed, the capability of transparency reporting: making necessary reporting; monitoring and maintaining the mechanism to track HCP related expense tying to HCP master file.
  • Internal Policy and Guidelines: Reviewing, recommending changes to functional lead, and implementing compliance related policies and guidelines such as compliance policy and HCP interaction and communication policy.
  • Compliance Training and Education: Conducting annual compliance training for all company employees and provide additional training, as needed.
  • Compliance Auditing and Monitoring: Planning and managing audits for high compliance risk areas with oversight from functional lead.
  • General compliance guidance: Providing guidance, support and appropriate advice regarding any other compliance matters associated with company activities.
  • Others: Performing other duties as needed as assigned by functional lead or management.

QUALIFICATIONS:

Core competencies, education, and experience.
  • Healthcare compliance certification (CHC) preferred, with at least 2-5 years of experience serving in a compliance related role in the pharmaceutical/medical device industry, with 5+ years overall work experience.
  • Established knowledge and understanding of pharmaceutical industry laws, regulations and guidelines involving off-label issues, anti-bribery and anti-corruption, customer/patient interactions, research misconduct.
  • Thorough functional knowledge of the elements of a pharmaceutical compliance program and thorough knowledge and understanding of the pharmaceutical industry.
  • Demonstrated ability to identify, assess, and prioritize higher risks versus lower risks.
  • Demonstrated ability to take gray areas/ambiguity in the laws/regulations or complex new areas and provide recommended courses of action to senior management.
  • Demonstrated project management skills and proven experience partnering with cross functional teams.
  • Strong business partner with a focus on collaboration and delivering results.
  • Collaborate well with other members of legal and compliance department.
  • Excellent written and verbal communication skills, with the ability to persuade others/change behavior across various levels in the organization.
  • Working relationships across all Santen Inc. at all levels, across all departments (Commercial, Medical Affairs, other R&D functions, Finance, HR, IT etc.), Santen Pharmaceutical Co., Ltd (parent company) and other affiliates, and external counsel.

For more information about our company and the work experience, please visit www.santenusa.com.