Compliance Director - Healthcare jobs in Santa Ana, CA

Overview

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beal, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role:  

The Director, Ethics, Risk & Compliance (ERC)-will be responsible to identify, assess, and support effective management of risks presented by Integrated Marketing strategies for assigned marketing domain areas across all US therapeutic areas (TAs) and products to ensure execution of strategies is in compliance with applicable NPC policies, procedures, and requirements. The ERC will clearly identify, assess, and articulate risks as part of early concept discussions for novel and complex marketing strategies (e.g., omnichannel engagement, use of dynamic content, social media) and recommend effective risk management when they are implemented. The ideal candidate is passionate about both enabling compliant marketing strategies and ensuring ERC guidance to Integrated Marketing teams is clear and actionable.

Responsibilities

Your Work:

• Provide specialized ERC advice to marketing domains with high and/or emerging risks (e.g. omnichannel engagement, use of dynamic content, social media) to assess risk in early concept discussions, discuss risk with business owners to achieve an aligned understanding, provide clear and actionable ERC advice on how to effectively mitigate such risks upon implementation, evaluate effectiveness of risk mitigation and document key milestones throughout the process.
• Effectively engage with Integrated Marketing leadership teams for assigned domains to ensure they have a holistic view of ERC risks presented in their strategies (key watch areas,what’s going well, etc.) and collaborate to implement strategies to address key or emerging risks.
• Proactively monitor evolving US healthcare environment, enforcement trends and compliance programs of other pharmaceutical, biotech and medical device companies related to assigned marketing domains to identify and share insights with the integrated marketing teams.
• Be a knowledge expert related to Big Pharma and biotech healthcare compliance policies, procedures, and CIA requirements and how they apply to associates’ roles and responsibilities throughout of the US organization.
• Proactively engage with Ops/Analytics teams supporting assigned Integrated Marketing teams to evaluate data to identify trends and proactively mitigate key and/or emerging risks.
• Develop trusted relationships with associates of all levels in Integrated Marketing teams to promote a SpeakUp culture and collaborate with Integrated Marketing teams to strengthen a positive culture towards compliance and ethical decision making as an integral part of how we reimagine medicine for patients.
• Engage with Medical/ regulatory leadership and related cross-functional leaders to ensure a holistic view of risks across the strategies leveraged for assigned therapeutic area(s) (key watch areas, what’s going well, etc.) and ensure clear and actional ERC guidance is provided or seamless transition to the appropriate ERC.

Qualifications

Education Requirements:

• Bachelor’s degree required; Master’s degree preferred.  

Job Requirements:

• 8 years in pharmaceutical, medical device or biotech companies
• 7 years of experience with consulting, compliance, or legal counseling within highly regulated industry
• 5 years of experience in a Marketing function

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time. 
• Finger dexterity sufficient to use a computer and to complete paperwork activities.
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
• Hearing sufficient to communicate with individuals by telephone and in person.
• May be required to work alternate shifts.
• Job is performed in an office environment.