Senior Specialist, Clinical Supplies Project Manager

Job Description

Job Description

Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic and operational plans for all activities associated with clinical supplies during the development process of a compound This position may be responsible for clinical supplies programs of varying complexity. This individual serves as the primary Global Clinical Supply point of contact to customers and as the Global Clinical Supply spokesperson at clinical development-related meetings (i.e. Clinical Supply Program Team, Clinical Trial Team, Clinical Development Sub-Team) and product development related meetings.

Primary activities include, but are not limited to:

• Chair the Clinical Supply Program Team (CSPT) and works closely with Clinical Trial Teams (CTT), Project Management (PM), Regulatory, and other functional area representatives to negotiate timelines and strategy for clinical supplies
• Acts as the main spokesperson between Global Clinical Supply and Clinical Development Execution Organization for all clinical supply related issues
• Interacts with various organizations such as Clinical Development Execution Organization, Regulatory, Chemistry, Manufacturing, and Control (CMC), Pharmaceutical Sciences & Clinical Supply (PSCS) Development Teams and Research Commercialization Quality as necessary to address drug supply-related issues
• Plans the progress of a product throughout the development life cycle, from designation as a Preclinical Candidate (PCC) through Phase IVN marketing studies, as it relates to clinical supply needs; plans for both in-house and in-licensed compounds
• Responsible and accountable for establishing the timelines for clinical supply needs per project; and providing the signal for manufacturing, packaging, sourcing, etc.
• Analyzes and anticipates project risk as they relate to clinical supply chain and prepares analyses/mitigation for review at appropriate Research and Development (R&D) and interdivisional meetings and reviews
• Responsible and accountable for utilizing key tools in the planning and managing of clinical studies. This may include Microsoft Project Plans, Actions, Issues and Risk Logs, forecasting tools, etc.
• Responsible for the Clinical Supplies section of the study protocol
• Responsible for the clinical supply budget for the respective program(s)
• Participate in Interactive Voice Response System Development and User Acceptance Training for given studies

Education:

• Bachelor's degree in a scientific, business or related discipline required, MS/MBA preferred.

Experience:

• At least 2 years of experience in planning, scheduling, coordination and processing of clinical supply activities, or the equivalent, are required.
• At least 1-year experience in project management

Personal Qualifications: This position requires skills including but not limited to the following areas:

• Creative analytical and problem-solving skills
• Interpersonal skills in verbal and written communication, ability to negotiate, resolve conflicts and engage in decision making to partner and influence across functional areas and organizations
• Knowledge of project management and Clinical customer relationship management
• Knowledge of drug development, destruction, reconciliation, distribution, and shipping processes I procedures
• Knowledge of order management, supply chain operations, and document control
• Above average proficiency in Microsoft applications (Word, Excel, PowerPoint,)
• Ability to organize and manage multiple tasks at one time and meet deadlines
• Familiarity with Good Manufacturing Practice (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution

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 ...

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. 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.

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 [email protected]
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R52429