Director, Clinical Literature Monitoring

Job Description

Position Description: Director, Clinical Literature Monitoring

The Director is responsible for the management and oversight of the day-to-day operations of the clinical literature information center, which is responsible for the screening of literature on company products to support pharmacovigilance and drug safety and for use in the Product Literature Database.

Responsibilities but are not limited to:

• Acts as a player-coach.

• Drives the team's capabilities by continuously introducing new ideas and information platforms, creating collaboration opportunities, and supporting literature search, copyright, and training.

• Develops and manages a small team of information scientists and vendor staff.

• Leads all aspects of the screening, indexing, abstracting, literature acquisition, and searching functions.

• Demonstrates expertise in pharmacovigilance and drug safety requirements for literature monitoring.

• Creates strategic road maps and annual budgets.

• Maintains up-to-date knowledge of biomedical literature, adverse event reporting, and copyright compliance.

• Represents the department with outside entities as appropriate.

• Regularly evaluates and updates processes and policies to ensure the most efficient use of resources.

• In collaboration with IT partners, manages the development and maintenance databases and supporting systems to ensure optimum performance, reliability, data integrity, security, and awareness of the latest technology in information storage and retrieval systems.

The Director works cross-functionally and uses experiences to assess the impact of decisions on other areas of the company. The Director leverages a strong scientific background, excellent communications skills, and project management skills to derive high-quality products to meet the diverse needs of the business in a timely, cost-effective manner. The role may also include managing other groups in the future. This position is a contributing member of the Information Sciences Leadership Team.

Primary activities include, but are not limited to:

• People management

• Lead a high-performing team to succeed in a matrix environment by coaching and mentoring

• Provide oversight for direct reports, including managing workload, performance, development, compliance, strategic planning, and work/life balance

• Strategy

• Build and facilitate cross-functional teams, establishing and supporting team goals

• Collaborate with stakeholders to ensure their needs for published literature are met, including regulatory requirements related to pharmacovigilance and drug safety

• Monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate

• Manage team activities and ensure work is delivered in a timely manner and within budget and track metrics

• Analyzes the effectiveness of current processes, and develops strategies to improve, simplify, enhance and automate

• Conduct business in accordance with Company values and standards

• Management of Literature Management

• Collaborates with pharmacovigilance teams in meeting current adverse event literature monitoring requirements

• Maintains expertise in developments in the fields of medical information, regulatory policy, adverse event reporting,

• Identifies and utilize the best available resources to conduct accurate, comprehensive, and cost-effective searches

• Provide for the published literature needs of the Company by regularly engaging with stakeholders, maintaining awareness of current information trends and systems, and developing strategic action plans

• Lead literature search projects/initiatives or other data management tasks

• Directs the development of, with input from internal stakeholders and knowledge of current regulatory requirements, the article selection, adverse event reporting, editorial, and indexing policies and procedures

• Creates, maintains, communicates, and trains on standard operating procedures (SOPs), guidelines, and job aids related to these functions

• Responsible for full cycle management of the vendors or external literature acquisition, from identification of resources, contracting, relationship management and financial reporting

• Oversees the collaboration with IT to maintain systems to ensure the maximum performance, reliability, data integrity, security, and precision and recall of the database

• Participates in end-user and system application development

Position Qualifications:

Education Minimum Requirement:

Degree in life sciences, information science, pharmacy, or related scientific discipline plus literature-related regulatory reporting:

• Bachelor's plus 12+ years of experience

• Master's plus 10+ years

• PhD plus 5+ years

Required Experience and Skills:

• 3+ years of work with biomedical literature and pharmacovigilance activities

• 3+ years of people management or supervisory experience leading teams

• Expert-level knowledge of licensed databases and scientific information resources, such as Dialog, PubMed, Embase

• 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:

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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:

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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.

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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:

$181,600.00 - $285,800.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, 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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a