Associate Director, Market Research Compliance #NCP1
- Kenilworth, NJ
The Associate Director, Compliance Global Markets Lead is responsible for ensuring that market research is conducted in an ethical and compliant manner in accordance with the laws, regulations, company policies and procedures, and governing body rules and standards.
The Compliance Lead will be a champion for ethical and compliant Market Research business processes, ensuring this is achieved through close partnership with key stakeholders in, market research, Legal, Compliance, Privacy, Procurement, and Pharmacovigilance at all levels of the business.
The Compliance Lead will maintain a vigilant watch over the regulatory environment specific to market research, alerting market research management and senior executives of emerging regulatory changes that may impact the business processes, make recommendations and act to communicate requirements to the headquarters and global market research community.
The Compliance Lead will be the focal point of contact and subject matter expert to Marketing and Market Research colleagues globally and will act as an advisor to market research to ensure that compliance requirements are met, and the market research community is appropriately trained with the knowledge to manage compliance requirements without undue delay or interruption to the business.
The compliance lead will assume responsibility for market research standards, systems, processes and applications used for review and approval of market research, document management and records retention in line with Company Policies, standards and specifications.
The compliance lead will be accountable for managing contractor resource for the Workflow and Document Management System, maintaining the relationship with the provider and enhancing and developing the system to meet future market research and broader company needs.
Primary activities include, but are not limited to:
- Accountable for the review and approval process of global HQ market research projects with key compliance stakeholders.
- Manage, update and enhance market Research Standard Operating Procedures, guidance, training and associated communications to deliver ethical and compliant research Maintain excellent working relationships with Global, Region and Countries stakeholders including country and regional cluster level Market Research, Legal, Compliance and Privacy, Pharmacovigilance and other associated stakeholders to ensure efficient integration of systems and processes through collaboration across key functions contributing to compliance.
- Manage and maintain records in organized systems to support regulatory reporting as required.
- Support the key stakeholders with internal audits, regulatory inspections and Late Case Investigations including the data requests, responding to and fulfilling audit or regulatory finding and associated CAPAs.
Minimum Education Requirement
- BA/BS or equivalent
- Preferred: MBA/MS
- Demonstrable experience (5-8 years) including marketing-related positions (e.g. research, forecasting/ analytics, marketing, sales, or associated support functions on either the client or agency side of the business)
- Expert knowledge of pharmaceutical market research ethical and compliance practices
- Strong knowledge of Data Protection & Privacy and pharmacovigilance requirements (specifically EMA GVP modules and FDA requirements).
- Working knowledge of commercial and FCPA laws and regulations as they apply to the pharmaceutical industry and specifically pharmaceutical market research.
- Proven quality systems management with analytical and data interpretation skills. Ability to distill down and synthesize complex information from various sources and create effective reports and solutions.
- Strong interpersonal skills, strong influencing, negotiating, conflict resolution skills.
- Strong commercial orientation and business acumen.
Our Human Health Division maintains a "patient first, profits later" ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
Who we are ...
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at email@example.com
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
No Travel Required
Flexible Work Arrangements:
Valid Driving License:
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