Director, Commercial Compliance & Ethics, APAC (Business level Japanese required)

Description

Director, Commercial Compliance & Ethics 

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know: 
WORK HERE MATTERS EVERYWHERE

Why Syneos Health
•    We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
•    We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
•    We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job responsibilities 
•    Lead a compliance team responsible for the development, implementation and oversight of day to day compliance program operations for one or more of the Company’s commercial lines of business, including Company and individual client-based policies, procedures and ethical standards (e.g., based on specific OIG Corporate Integrity Agreement requirements applicable to the client), training and education, compliance monitoring mechanisms, and providing ongoing compliance operational support to clients and internal commercial business stakeholders.  Develops operating strategy, policies and procedures for subordinates and decisions are likely to impact multiple areas and/or client accounts.  
•    Develop company commercial business and client-specific compliance policies, rules and standard operating procedures to ensure operational compliance by company employees with the following pharmaceutical industry legal, regulatory compliance requirements and ethical standards (as applicable) that govern the sale or promotion of pharmaceuticals or medical devices and interactions with health care providers and patients. 
•    Provide guidance to internal business stakeholders on applicable commercial compliance requirements to commercial lines of business, including product or device promotional requirements and associated communications, sample management activities, speaker bureaus, incentive plans, fraud, waste and abuse requirements (off label promotion, anti-kickback requirements), etc.
•    Ensure company employees conduct business on behalf of commercial clients in a manner that is consistent with the Company’s Code of Business Conduct and Ethics and other applicable corporate compliance and ethics program policies and procedures, including any applicable client corporate compliance or ethics rules. 
•    Collaborate with and provide support to business development and commercial business leadership to launch new client lines of business or existing client additional lines of commercial business, including developing new or adapting existing commercial compliance policies, procedures, training and educational requirements and operational compliance oversight mechanisms as necessary to support the particular launch.  
•    Collaborate with and provide support to internal stakeholders (Corporate Compliance, Human Resources, commercial compliance business management) and clients, as appropriate, when instances of non-compliance with commercial compliance company or client requirements are detected, including in the investigations process to ensure prompt, effective action is taken to determine the nature and extent of the non-compliance, identity root cause and institute effective individual disciplinary action or programmatic changes, as applicable.  
•    Lead development of applicable risk management tools and ongoing monitoring to support prompt and effective identification of commercial compliance risks, identification of programmatic gaps and implementation of corrective actions.
•    Act as a compliance and ethics role model and ambassador to create awareness and promote compliance with the Company’s Code of Conduct and Business Ethics and other corporate compliance policies (e.g., conflicts of interest, gifts and entertainment, anti-bribery/anti-corruption policy). 

Qualifications

What we’re looking for
•    Bachelor’s Degree, preferred, in a healthcare related field and relevant work experience in a compliance role with a company, preferably in the healthcare (bio/pharma/med device) industry.
Experience with:
•    Broad-based compliance program support 
•    Development and implementation of compliance training programs; experience with learning systems 
•    Policy development and implementation 
•    Business process improvements/project management 
•    Compliance-related databases 
•    Interaction with regulators/agencies 
•    Interaction with clients; strong customer relations skills a must
•    Interaction with upper management 
•    Investigations; development and implementation of corrective actions 

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.