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Job Information

Merck Senior Specialist, Planning & Scheduling in Indianapolis, Indiana

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.

Global Clinical Supply Operations is seeking a highly motivated individual to support clinical supply label production. Team member will be responsible to read, comprehend, and translate clinical trial protocols /packaging specifications into clinical label generation software. The incumbent will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within our Company's label systems. They will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs. The successful candidate should have a working knowledge of clinical labeling, packaging and or operations planning including the understanding that all clinical supplies and associated documentation are processed according to Standard Operating Procedures, study protocols, Good Manufacturing Practice /Good Documentation Practice and appropriate company safety requirements to meet exacting standards defined by our company, the FDA and EU or other international regulatory agencies.

Primary responsibilities :

  • Interpret clinical study designs and Clinical Supplies Specification documentation.

  • Manage Multi-language booklet label (MLBL) and Single Panel Clinical Label Proof process.

  • Manage MLBL and Single Panel label orders including obtaining quotes from vendors and working with procurement on vendor selection and approval.

  • Understand and maintain study blinding.

  • Manage Translation Requests and maintain Label Translations Library.

  • Liaise with Clinical Supply Program Managers, Schedulers, Quality, Pharmaceutical Sciences, or other stakeholders as needed.

  • Liaise with country-level Clinical Operations Personnel and or Regulatory Affairs to address questions, revise translations, and update regulatory requirements as needed.

  • Perform visual inspection and accountability for label proofs, clinical labels and RCE’s.

  • May represent Clinical Packaging on internal or cross-functional teams. Will undertake and lead specific projects within the group on as needed basis.

  • Provide detailed analysis of issues and collaborate for creative problem solving.

  • Participate as necessary in complaint and deviation investigations with a focus on true root cause, and creation of appropriate Corrective and Preventative actions (CAPA's). Drive CAPA's to closure.

  • Author / review Standard Operation Procedures (SOPs) as needed.

  • Train new hires or junior team members and remain proficient in appropriate systems and software.

Qualifications:

  • Capable within Microsoft Office applications and background in SAP, Clinical Supplies Labeling System (CSLS), and other relevant systems.

  • Provide detailed analysis of issues and collaborate for creative problem solving.

  • Demonstrate strong interactive skills to work in a team environment.

  • Demonstrate excellent oral and written communication skills.

  • Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution.

  • Strong attention to detail.

Education:

  • High School Diploma. Bachelor's degree in a scientific discipline preferred.

Required experience:

  • 5 years of pharmaceutical industry experience.

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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:

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R160316

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