Job Description
Focusing on novel technologies and innovations is a key strategic direction for our company as seen in global, regional and local market level activities. This role is an essential part of that strategy in the clinical supply space and will serve as the central point of contact for all Global Clinical Supply innovation efforts, leading the incorporation of new packaging, labeling, and distribution technologies to drive more informed, real-time planning and quality decisions related to the conduct of our company's clinical trials. This role will seek to champion novel technologies to drive faster registration of investigational products to provide patients access to new medicines. This role will serve as the Center of Excellence to assist colleagues within and outside of Global Clinical Supply in novel, customer-focused or business need-driven clinical supply technologies.
This role will also link to customer-centricity account management.
* Lead our company's global clinical supply packaging, labeling, and distribution technology development efforts. Create and maintain standard processes for evaluation and implementation of customer-focused smart/enabling packaging, labeling, and distribution technologies in clinical supply. Ensure new related technologies are considered during the product/clinical development process.
* Represent or coordinate representation of Global Clinical Supply, internally or externally, on different new technology-focused teams such as Transcelerate, Instructor Lead Training, Smart Trials, 3D Printing, Innovation Community of Practice, etc. Drive project sponsorship to prioritize and gain resources in support of new initiatives coming from these teams. Act as an internal and external thought leader for innovation and customer-centric activities in the clinical space.
* Manage challenges inherent with new technology implementation (Regulatory, Quality, Supply Chain, Legal, External Partnerships, Safety). Break down barriers, and lead the development of procedures aimed at enabling technology use.
* Cultivate and manage a physical and virtual library of innovation-focused clinical supply packaging/labeling/distribution standard offerings from our company, partners, and competitors to address customer needs. Develop and implement effectiveness metrics for decision making and monitoring of technologies post-implementation. Lead discussions with Clinical and Product Development teams on which technologies to pursue, based on the challenges they are facing.
* Ensure our Research Laboratory representation on Human Health and Manufacturing Division commercial innovation / customer-centricity efforts. Leverage these efforts to inform and prioritize new technologies within the clinical space. Act as an intermediary across division boundaries to ensure line of sight, and enable rapid alignment of efforts across all phases of development.
* Oversee and/or execute the design, planning, and implementation of customer insight and evaluation techniques. Create, maintain, and make visible a customer-focus organizational ecosystem map for stakeholders that drives activities impacting the clinical supply chain globally.
* Tracks and captures future clinical supply chain challenges, and uses complex problem-solving tools/techniques to identify technology-based solutions that are aligned with our company's long-term strategy. Influence key stakeholders to act based on available data.
Education Minimum Requirement:
Bachelor's in Engineering or Biology/Chemistry Sciences. An advanced degree is preferred. A Master's in Business Administration or other business degree, in addition to the required science or engineering education, is beneficial.
Required Experience and Skills:
* At least 10 years experience in a technology and/or operations management role within the pharmaceutical industry.
* Experience with pharmaceutical packaging (primary packaging of solid dosage forms, secondary packaging of vaccines/biologics, medical devices).
* Strong understanding of Current Good Manufacturing Practices, including Food & Drug Administration and European Medicines Agency.
* Demonstrated strong project management of Cross-functional teams through project planning, execution, monitoring and closeout phases to deliver successful completion to project target milestone dates.
* Ability to work effectively across boundaries to build strong collaborative relations with other internal Pharmaceutical Sciences & Clinical Supply partner groups, Global Clinical Trial Operations, Global Science, Technology & Commercialization and external partners.
* Demonstrated strategic ability to develop innovative solutions to undefined problems and business processes to meet the needs of key stakeholders and project sponsors.
* Operational Excellence methodology such as Six Sigma and Lean methods principles and tools.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. 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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Work Week
Shift:
1st - Day
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R87600
Kenilworth, NJ
Merck & Co., Inc. provides healthcare solutions worldwide. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services, and Alliances. The company offers therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, chronic hepatitis C virus, HIV-1 infection, intra-abdominal, fungal infection, insomnia, and inflammatory diseases. It also provides neuromuscular blocking agents; cholesterol modifying medicines; and anti-bacterial and vaginal contraceptive products.
In addition, the company offers products to prevent chemotherapy-induced and post-operative nausea and vomiting; treat non-small-cell lung, ovarian and breast, thyroid, and cervical cancer, as well as brain tumors; and prevent diseases caused by human papillomavirus, as well as offers vaccines for measles, mumps, rubella, varicella, shingles, rotavirus gastroenteritis, and pneumococcal diseases.
Further, it provides antibiotic and anti-inflammatory drugs to treat infectious and respiratory diseases, fertility disorders, and pneumonia in cattle, bovine, and swine; vaccines for poultry; parasiticide for sea lice in salmon; and antibiotics and vaccines for fishes. Additionally, the company offers companion animal products, such as ointments; diabetes mellitus treatment and anthelmintic products; products to treat fleas and ticks in dogs and cats; fertility management products for horses; vaccines for dogs, cats, and horses; and products for protection against bites from fleas, ticks, mosquitoes, and sandflies.
It has collaborations with AstraZeneca PLC; Bayer AG; Eisai Co., Ltd.; and Intec Pharma Ltd. The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, distributors, veterinarians, animal producers, and managed health care providers. Merck & Co., Inc. was founded in 1891 and is headquartered in Kenilworth, New Jersey.