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Merck Associate Director, Clinical Supplies Project Manager in Helena, Montana

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Primary Activities:

  • Interacts with various organizations as a lead GCS Planning program representative such as Clinical Sciences and Study Management (CSSM), Regulatory, CMC, PharmSci, Development Teams, and Global Development Quality as necessary to address drug supply related topics

  • Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across assigned program(s)

  • Responsible and accountable for establishing the timelines for bulk manufacturing needs across assigned program(s)

  • Initiates drug supply projections in SAP for new studies in assigned program(s)

  • Responsible for the clinical supply budget for respective program(s)

  • Chairs the Clinical Supply Program Team (CSPT) and work closely with Clinical Trial Teams (CTT), Project Management (PM), Regulatory and other functional area representatives to negotiate timelines and strategy for clinical supplies across all assigned program(s)

  • Ensures GCS Planning Leadership is aware of program pipeline forecast to ensure proper resourcing of all levels of planning support

  • Responsible and accountable for utilizing key tools in the planning and managing of clinical supplies for assigned program(s). This may include Microsoft Project Plans, Actions, Issues and Risk (ADI) Logs, forecasting tools (SAP), etc.

  • Mentors new team members, as needed

  • May participate as an SME in an area of expertise

Education:

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

  • 5+ years’ relevant experience in pharmaceutical and/or clinical drug development with experience in planning, scheduling, coordination and processing of clinical supply activities, or the equivalent

Skills:

  • Excellent oral (including presentation) and written communication, project management, creative analytical and problem-solving skills

  • Demonstrates ability to negotiate, resolve conflicts and engage in decision making as well as 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 and procedures

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

  • Ability to organize and manage multiple tasks at one time and meet deadlines

  • Familiarity with GMP requirements, quality procedures and SOP execution

GCSCareer

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 .

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

2

Requisition ID: R147198

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