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Senior Specialist, Clinical Literature Monitoring

Merck

Merck

Durham, NC, USA
Posted on Friday, June 7, 2024

Job Description

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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$111,400.00 - $175,300.00

Available 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:

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

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.


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