Senior Specialist, Clinical Literature Monitoring

Merck Group

3+ years

$111,400.00 - $175,300.00

Rahway

15 June 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Specialist, Clinical Literature Monitoring

Company: Merck & Co.

Category: Regulatory Affairs

Job Type: Full Time

Location: Rahway, New Jersey (NJ), United States

Post Date: 06/08/2024

Job Description

Position Description:
The Senior Specialist, Clinical Literature Monitoring at Merck & Co. is responsible for providing timely and relevant information on the company's products and interests sourced from global biomedical literature. This role supports regulatory, clinical research, marketing, and legal functions by overseeing the collection, storage, and dissemination of literature-related information. The Senior Specialist plans, organizes, monitors, coordinates, and evaluates the work of vendor screening/abstracting/indexing staff to ensure efficient operations. Additionally, they maintain awareness of literature-related copyright compliance, adverse event reporting, and information retrieval systems.

Primary Activities:

Monitor quality, accuracy, and timeliness of biomedical literature screening, adverse event reporting, abstracting, and indexing.
Assist in acquiring and translating published biomedical literature, including conference abstracts.
Develop policies and procedures for article selection, adverse event reporting, editorial, and indexing, based on regulatory requirements and internal stakeholder input.
Ensure comprehensive creation, maintenance, and communication of standard operating procedures (SOPs), guidelines, and job aids.
Conduct training for vendor screeners/abstractors/indexers and internal team members.
Participate in managing published literature and conference abstract acquisition and translation.
Collaborate with regulatory and pharmacovigilance teams to meet literature-related adverse event monitoring requirements.
Engage in evaluating proposals and developments for applicability to specific information needs.
Collaborate with internal and external organizations in system development and integration.
Maintain awareness of developments in medical information, regulatory policy, adverse event reporting, and information services.
Participate in maintaining the Company Product Literature Database and data processing activities.

Position Qualifications:

Education Minimum Requirement:

Bachelor's degree in life sciences, information science, pharmacy, or related discipline with literature-related regulatory reporting.
- Bachelor's degree with 5+ years of experience.
- Master's/PhD with 3+ years of experience.

Required Experience and Skills:

3+ years of work with biomedical literature and pharmacovigilance activities.
Basic knowledge of information storage and retrieval systems and pharmaceutical regulations.
Strong writing skills, attention to detail, and time management.
Proficiency in foreign languages desirable.
Experience with vendors, audits, and inspections related to pharmacovigilance.

Preferred Experience and Skills:

Knowledge of biomedical literature sources, databases, indexing, and copyright compliance.
Familiarity with semantic technologies, Natural Language Processing (NLP), Machine Learning (ML), or Artificial Intelligence (AI).
Experience with the system development lifecycle (SDLC).

Travel Requirements: Up to 10% travel, including international.

Flexible Work Arrangements: Hybrid.

Expected Salary Range: $111,400.00 - $175,300.00

Benefits: Bonus eligibility, long-term incentives, healthcare, insurance, retirement benefits, paid holidays, vacation, and sick days.

Job Posting End Date: 06/22/2024

Note: A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date.

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Senior Specialist, Clinical Literature Monitoring

Job Description

Job Title: Senior Specialist, Clinical Literature Monitoring

Job Description

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