Merck Vocabulary Specialist - Medication in Rahway, New Jersey

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Under the direction of the applicable management, the GDO Vocabulary Specialist is accountable for executing vocabulary and dictionary management support activities in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary activities include, but are not limited to:

  • Perform vocabulary management activities used to support the medical, medication and lab coding for standardization of clinical trial terminology.

  • Serve as subject matter expert for encoding dictionary processes globally and locally, at the trial level, program level and Therapeutic Area Level.

  • Serve as point of contact for Encoding & Vocabulary groups in industry forums, serve as the Merck liaison for Maintenance and Support Services Organization (MSSO) for MedDRA dictionary, and Uppsala Monitoring Centre(UMC) for WHODrug dictionary.

  • Interact and communicate with customers and stakeholders both internal and external to GDMS.

  • Research stakeholder and customer questions and provide accurate and consistent encoding advice based on the industry best practices, internal and industry guidelines and regulatory requirements.

  • Accept and execute special responsibilities related to process maintenance, data quality assessment, training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.

  • Review for consistency and accuracy of verbatim synonym mapping in Thesaurus Management System (TMS) by performing quality review.

  • Perform required leveling activities for Integrated Summary of Safety (ISOS).

  • Perform required encoding for migration studies that are required for Clinical Data Repository (CDR) submissions.

  • Provide assistance in resolving study data Milestone Prep Report issues.

  • Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate.

  • Coordinate the monthly Merck & Co., Inc. vocabulary updates with Oracle.

  • Independently manage supportive tools and services (i.e.global Merck MedDRA mailbox, CRISP mailbox, etc.) responding to questions and resolving encoding or reporting issues in a timely manner

  • Manage Merck MedDRA dictionary, WHODrug dictionary, CDISC lab test dictionary, and units of administration and units of measurement dictionaries.

  • Develop and/or deliver MedDRA, WHODrug and lab test training.

  • Assist with MedDRA and WHODrug versioning activities as needed

  • Maintain the MedDRA Term Selection Guidelines, WHODrug/ Merck Drug and Lab encoding guidelines.

  • Provide vocabulary expertise regarding lab test names and results, lab units of measures, and organisms.

  • Add new terms to the CDISC lab test dictionary and the units of administration and units of measurement dictionaries.

  • Maintain the CDR Units of Measurement Conversion Table and the CDR Standard Character Results Table.

Education Minimum Requirement:

B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Medical Technology, Biological Sciences, or health care related discipline.

Required Experience and Skills:

  • Six years’ experience in Pharmaceutical Encoding and/or Vocabulary Management.

  • Knowledge of Laboratory Data Review.

  • Knowledge of WHODrug, industry best practices.

  • Excellent Oral and written English language skills.

  • Knowledge of regulations and policies applicable to the pharmaceutical industry encoding.

  • Advanced overall working knowledge of the clinical development process and the value of encoding.

  • Proficient working knowledge of clinical practice and medical terminology.

  • Ability to work cross functionally and as part of a team.

  • Be able to work under pressure in a changing environment with flexibility.

  • Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.

  • Ability to coordinate the work of others and influence decision making.

  • Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.

  • Exceptional organizational, problem-solving and negotiating skills.

  • Demonstrated advanced project management and leadership skills

  • Experience with process assessment and documentation updates.

Preferred Experience and Skills:

  • Knowledge of Oracle suite of products - InForm, Central Coding Tool, Thesaurus Management System (TMS).

  • Previous experience of User Acceptance Testing.

  • Previous experience with training and mentoring development.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Clinical Data Management

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-NJ-Rahway

Title: Vocabulary Specialist - Medication

Primary Location: NA-US-PA-West Point

Requisition ID: CLI007422