Senior Specialist, Clinical Literature Monitoring
Merck
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Position Description: Senior Specialist, Clinical Literature Monitoring
Provides pertinent and timely information on our Company’s products and interests from the world’s biomedical literature in support of regulatory, clinical research, marketing, and legal functions. Plans, organizes, monitors, coordinates, and evaluates the work of vendor screening/abstracting/indexing staff to ensure effective and efficient collection, storage, and dissemination of literature-related information. Maintains up-to-date awareness in the areas of literature-related copyright compliance, adverse event reporting, and information storage and retrieval systems. Performs screening, abstracting, indexing, and other project work as time allows. Engages stakeholders and supports their requests.
Primary activities include, but are not limited to:
Monitors the quality, accuracy, and timeliness of biomedical literature screening, adverse event reporting, abstracting, and indexing
Assists with the acquisition and, where applicable, translation of published biomedical literature, including conference abstracts
Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing policies and procedures
Ensures comprehensive creation, maintenance, and communication of all standard operating procedures (SOPs), guidelines, and job aids related to these functions
Assists with the training of vendor screeners/abstractors/indexers, and internal team members
Assists with end-user training and request fulfillment
Participates in the management of published literature and conference abstract acquisition and translation
Liaises with regulatory groups to ensure search request results meet current regulatory requirements
Collaborates with pharmacovigilance teams to meet current literature-related adverse event monitoring requirements, including collaboration with ex-US PV groups to develop of journal lists for adverse event screening
Assists in the evaluation of proposals and developments sponsored by intra-company information or systems units for applicability to the specific information needs of Clinical Literature Information Center (CLIC) end-users
Collaborates with internal and external organizations in the development and integration of literature-related systems and information
When necessary, performs ad hoc screening, abstracting, indexing, and editing functions
Maintains personal awareness of developments in the fields of medical information, regulatory policy, adverse event reporting, information storage and retrieval, and information services
Participates in the collaboration with our Company's IT to maintain the Company Product Literature Database to ensure the maximum performance, reliability, data integrity, security, copyright compliance, and precision and recall of the database. Leads end-user and system application development
Participates in data processing, harmonization, deduplication, and standardization activities
Participates in the development, maintenance, and control activities of CLIC terminology to ensure optimal precision and recall of CLIC data
Position Qualifications:
Education Minimum Requirement:
Degree in life sciences, information science, pharmacy, or related scientific discipline plus literature-related regulatory reporting
Bachelor’s and 5+ years
Master’s/PhD and 3+ years
Required Experience and Skills:
3+ years of work with biomedical literature and pharmacovigilance activities
Basic working knowledge of biomedical literature and information storage and retrieval systems; an understanding of US and ex-US pharmaceutical regulations (specific knowledge of literature-related adverse event reporting preferred); good writing skills; attention to detail; good time management skills; foreign language proficiency is desirable
Working knowledge of information storage and retrieval systems
Experience working with vendors that provide systems and services
Experience with audits and inspections, especially those related to pharmacovigilance
Preferred Experience and Skills:
Knowledge of biomedical literature sources and content
Knowledge of commercial biomedical database structure, content, and content search/retrieval
Knowledge of biomedical literature indexing
Familiarity with copyright compliance
Familiarity with the application of semantic technologies, Natural Language Processing (NLP), Machine Learning (ML) or Artificial Intelligence (AI)
Experience with the SDLC (system development lifecycle)
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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Expected salary range:
$111,400.00 - $175,300.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/22/2024*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.
Job Posting End Date:06/22/2024
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.
Requisition ID:R296351
This job is no longer accepting applications
See open jobs at Merck.See open jobs similar to "Senior Specialist, Clinical Literature Monitoring" Out for Undergrad.