Associate Director, Business System Lead - Labeling Management ( MERCUSR115176ENUS)
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
As a part of our Intelligent Integration & Labeling Management team, the primary responsibilities will include:
- Project Lead for System Development, Maintenance, Enhancement and System Monitoring related initiatives.
- Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs.
- Facilitate System Operations Meetings including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities.
- Lead/Support the development of User facing System Resources ensuring supporting materials remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources.
- Support System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases.
- Oversee the System Support Model for systems within remit including:
- Monitor user support cases, ensuring proper investigation are conducted, CAPAs detailed and closed effectively and communication is consistently done to reduce instances of recurrence.
- Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users.
- Oversee the System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally.
- Provide support and facilitation for the System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested.
Preferred Experience and Skills:
- Candidate must be familiar with IT system and business process support, preferably in the Regulatory, Labeling or Artwork Management space with general understanding of Label Update process.
- Process-oriented with familiarity of GMP requirements and working in a highly regulated industry.
- Experience with business process mapping and system design for workflow management is an asset.
- Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.
- Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications.
- Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.
- Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information.
- Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships.
- Effective communication skills (verbal and written).
- Ability to work cooperatively with others and provides significant contributions as a member of a team in addition to serving in a leadership capacity.
- Strong organizational skills.
- The ability to be flexible and handle multiple tasks well, under pressure.
- Demonstrates strong attention to detail
Required experience and skills:
- Minimum of 5 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience and experience with IT System/Business System Management.
Education Min. Requirement:
- BS/BA or equivalent certification/experience in science, engineering, IT, Project Management or related discipline with functional working experience in System Development/Management within Research or Manufacturing areas
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
Invent. Impact. Inspire.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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