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Senior Specialist, Clinical Supplies Project Manager

at Merck in Dover, Delaware, United States

Job Description

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

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 position 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, 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

+ 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; MS/MBA preferred.

Experience:

+ 6+ years of relevant work experience.

+ At least 2 years of experience in planning, scheduling, coordination and processing of clinical supply activities, or the equivalent.

+ At least 1 year experience in project management.

Qualifications and Skills:

+ Creative analytical and problem-solving skills

+ Excellent interpersonal and communication (verbal and written) skills, 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 & procedures

+ Knowledge of order management, supply chain operations, and document control

+ High proficiency in Microsoft Office suite (Word, Excel, PowerPoint,)

+ Ability to organize and manage multiple tasks simultaneously and meet deadlines

+ Familiarity with Good Manufacturing Practice (GMP) principles, quality procedures, and Standard Operating Procedure (SOP) execution

GCSCareer

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.

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.

Residents of Colorado

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Secondary Language(s) Job Description

Sous réserve de la loi applicable, tous les candidats à l’embauche devront démontrer qu’ils ont reçu une série complète de vaccins contre la COVID-19, qu’ils ont l’intention de se faire vacciner contre la COVID-19 d’ici le 1er novembre 2021 ou qu’ils sont admissibles à un accommodement médical ou religieux relativement à cette exigence de vaccination. Les candidats embauchés qui ne sont pas vaccinés d’ici le 1er novembre 2021 et qui ne sont pas admissibles à un accommodement médical ou religieux requis par la loi feront l’objet de mesures disciplinaires pouvant aller jusqu’au congédiement, conformément à la loi applicable.

Travaillant de façon autonome, le chef de projets pour les fournitures cliniques conçoit des plans stratégiques et opérationnels pour toutes les activités associées aux fournitures cliniques pendant le processus de développement d’un composé. Il peut être responsable de programmes de fournitures cliniques de complexité variable. Il agit comme principal point de contact du groupe Approvisionnement clinique mondial pour les clients et comme porte-parole du groupe lors des réunions liées au développement clinique (c.-à-d. équipe Programme d’approvisionnement clinique, équipe Essais cliniques, sous-équipe Développement clinique) et au développement de produits.

Le titulaire de ce poste assumera, entre autres, les responsabilités suivantes :

+ Diriger l’équipe Programme d’approvisionnement clinique et c

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Job Posting: JC189753672

Posted On: Aug 11, 2021

Updated On: Oct 22, 2021