Senior Director, Compliance Evinova

About Evinova

Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigor, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a healthtech business within the AstraZeneca Group

This is what you will do:

The Evinova Senior Compliance Director is the primary strategic compliance advisor to the Evinova Business Globally. You will deliver efficient and consistent support across Evinova’s markets, including our key hubs in the US, Spain, Sweden and the UK.  The position reports to the Chief Legal and Compliance Officer and will work directly with the Evinova LT and senior AZ Compliance stakeholders to drive best practice across the enterprise

You will be responsible for: 

Driving the development, implementation, and management of the compliance program for Evinova’s Business globally. In this role, you will partner with senior leaders to set the strategic tone and align the tactical direction for the organization in line with applicable local regulations and industry codes. 

You will: 

Partner with senior leadership to identify, evaluate, and mitigate healthtech and software compliance-related legal and reputational risks, focusing on key risks for a sales based Software as a Service (“SaaS”) organization in a healthtech setting

• Establish a strong first line of compliance defense through a high-performing compliance champions network, with a focus on software engineering and product development teams

• Coordinate the development of formal and informal training programs and other internal communications to address compliance-related risks, deliver compliance program key messages, and build a culture of ethics and integrity

• Lead and/or serve as a major contributor to key strategic compliance projects implemented across Evinova’s Global Business

• Provide change management and cultural leadership through the continued implementation and maturation of the Evinova compliance program

• Analyze internal and external ethics and compliance developments and implement responses to these developments as appropriate

• Serve as a partner for compliance assurance activities, investigations, and internal and customer audits, including assisting with the implementation of mitigation and remediation measures

• Act as an internal subject matter expert to members of the Evinova LT and wider Evinova Business on healthtech and software compliance issues

• Develop strong relationships with AstraZeneca Compliance colleagues, establishing clear guidance for where AstraZeneca compliance teams and policies should and should not be leveraged within Evinova – and clearly explaining this within the Evinova Global Business; this includes aligning with Global Nominated Signatory colleagues and Global Business Services colleagues within AstraZeneca on Evinova’s approach 

You will need to have:

• Relevant pharmaceutical industry experience, with the majority of that experience in healthtech and software compliance-related roles 

• Significant leadership experience, whether from managing high profile projects, serving as a matrix manager, or leading a team of direct reports

• Substantial experience applying healthtech and software compliance principles to pharmaceutical industry practices and interpreting relevant industry codes

• The highest ethical standards, as well as an ability to operate with absolute discretion and objectivity

• Excellent written and verbal communication skills 

• High learning agility and adaptability

• Excellent interpersonal skills, with an ability to influence across all levels with a solution-oriented mindset, including the ability to constructively challenge management when appropriate

• A demonstrated track record of driving results as an effective a team member and leader in a highly matrixed organization

• The ability to operate independently with limited management oversight

• Full professional proficiency in the English language 

• The duties of this role are generally conducted in an office environment – as is typical employees must be able, with or without an accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours in adherence with applicable in-office work policies

We would prefer for you to have:

• Prior in-house experience in a compliance, legal, finance, risk management or regulatory function at a pharmaceutical company

• Prior experience in a sales based SaaS organization, including dealing with compliance risks relating to software as a medical device (“SaMD”). 

• A post-graduate degree (Master’s or higher) and/or professional licensure in a relevant field, such as a post-graduate legal, business, or scientific degree, or professional licensure as an accountant or certified privacy professional

• Knowledge of privacy and data protection laws preferably across multiple jurisdictions; experience in privacy program management