Senior Specialist, Scientific Reference Data

Job Description

Be part of a dynamic team that is dedicated to accelerating research and innovation. We are seeking a passionate Senior Specialist to join our Scientific Reference Data team. In this position you will be responsible for delivering and maintaining standardized reference data utilized across the company to promote a frictionless exchange of scientific cross-divisional data. A successful Senior Specialist will be open to explore and leverage multiple tools, internal and external reference databases and automation solutions in the pursuit of providing accurate, consistent and timely shared reference data. The ideal candidate will possess scientific acumen along with strong data handling technical skills, a penchant for accuracy and consistency, excellent communication skills, and a background in pharma/biotech. Previous experience with implementing and managing clinical and regulatory data standards is a big plus. If you believe in the power of a strong data foundation as an accelerator of scientific progress and are committed to ensuring excellence in data standardization, we invite you to apply to our team.

Primary activities include, but are not limited to:

• Identifying, evaluating & implementing new scientific, clinical and regulatory reference data sources
• Ensuring timely authoring, publication and maintenance of reference data in a centralized database
• Defining data quality rules for reference and master data
• Defining data stewardship workflows and access policies
• Utilizing knowledge of the drug development process and of master data principles to assign company identifiers and descriptive metadata for small molecules, biologics, vaccines, & medical devices
• Creating and maintaining documentation, operating procedures, and training materials to enable adherence to relevant standards and policies
• Performing regular data integrity reviews and technical analysis in addressing data quality issues
• Contributing as a key player in defining and enabling reference data ingestion and maintenance processes
• Maintaining current knowledge of industry data standards for pharmaceutical products and associated activities
• Supporting maintenance and SDLC testing for reference data systems
• Building and maintaining excellent relationships with IT partners, end users/stakeholders, including active outreach and engagement
• Identifying opportunities to improve efficiency, effectiveness and quality and implement changes

Education Requirements:

• Degree in life sciences, information science, or related scientific discipline, plus pharma/biotech industry or healthcare experience
  
  • Bachelor's and 5+ years' experience
  • Master's/PhD and 3+ years' experience

Required Experience and Skills:

• Familiarity with ontologies, data standards, taxonomies, and terminologies relevant to the biomedical industry (e.g. ICH, MedDRA, CDISC, HL7, EMA SPOR, GSRS, IDMP, WHO-Drug and ATC classes, Snomed, MeSH)
• Experience with reference data management systems, content, and processes
• Experience in master data management, data standards and business rules, provenance and stewardship
• Experience with data modeling, automation and scripting tools to manage, extract, manipulate and report data
• Experience or understanding of drug discovery, development and research, clinical data coding and experience working within a regulated environment
• Ability to engage stakeholders to determine reference/master data requirements in support of their business needs, and deliver the data solution
• Excellent written and verbal communication skills with the ability to convey technical and business information
• Strong prioritization and project management skills, with high attention to detail
• Ability to work with minimal oversight within a matrixed environment to drive tasks to completion and to act with appropriate accountability
• Excellent customer service orientation with prompt response to inquiries
• Ability to work under pressure in a changing environment with flexibility
• Proficiency with collaboration and productivity tools (MS Teams, Jira, Confluence, Excel, MS Power Automate, etc.)

Preferred Experience and Skills:

• Experience in designing and developing custom reference data, controlled vocabularies, taxonomies, ontologies
• Familiarity with the implementation of FAIR principles
• Experience with data structures (e.g. relational, hierarchical, graph) and data exchange formats (e.g. JSON, XML, RDF)
• Experience with data engineering tools (i.e., SQL, Python, Power Automate, etc.)
• Experience with cloud-based data platforms and APIs for extracting, processing and sharing reference data
• Knowledge of text mining, machine learning, and natural language processing for data curation and enrichment
• Familiarity with small molecules, biologics, vaccines and medical devices
• Experience with biomedical and/or chemical searching resources (SciFinder, STN, Medline/PubMed, Dialog, etc.)
• Experience writing and maintaining process documentation

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$114,700.00 - $180,500.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ;br>
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Adaptability, API Platforms, Automation, Biopharmaceuticals, Biopharmaceutics, Change Management, Data Analysis, Data Curation, Data Engineering, Data Integrity, Data Management, Data Quality, Data Requirements, Data Standards, Data Stewardship, Data Taxonomy, Good Manufacturing Practices (GMP), Key Performance Indicators (KPI), Master Data Management (MDM), Project Management, Project Prioritization, Reference Data, Reference Data Management, Taxonomy Management

Preferred Skills:
API Development, Business Process Automation, Clinical Data Interchange Standards Consortium (CDISC) Standards, Drug Development, Drug Discovery Process, ICH Guidelines, ISO IDMP, MedDRA, Microsoft Power Automate, Ontology Development, Resource Description Framework (RDF), Script Development, SNOMED CT, Structured Query Language (SQL), Writing Technical Documents

Job Posting End Date:
09/5/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.