Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Sr. Specialist, Clinical Literature Monitoring Consultant (Remote) to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Position Description: Sr. 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. Performs screening, abstracting, indexing, and other project work as needed. Plans, organizes, trains, monitors, coordinates, and evaluates the work of screening/abstracting/indexing workload 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. Engages stakeholders and supports their requests.

Main Job Tasks and Responsibilities:

Performs screening, abstracting, indexing, and editing functions
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 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
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

Education and Experience:

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

Bachelor’s and 5+ years

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.

Preferred Experience and Skills:

Experience with audits and inspections

Knowledge of biomedical literature sources, content, and indexing
Knowledge of commercial biomedical database structure, content, and content search/retrieval
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)

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific .

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City) *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

LinkedIn Profile

Website

Are you legally authorized to work in the country that you are being hired? *

If "yes", will you now or in the future require sponsorship to work in the country that you are being hired? *

What type of employment are you seeking? *

  Permanent
  Subcontractor
  Intern
  Temporary

Area of expertise - Therapeutic area or other skills

Have you previously worked for ClinChoice or its subsidiaries? If yes, please provide additional details

Do you have a friend or family member working for ClinChoice? If yes, please provide additional details.

Are you currently employed? *

Current Address

Date available to work? *

Employment History: Please list your two most recent employers, including name of the company, job title, and dates employed *

Are you willing to undergo a background check upon employment? *

If hired, can you furnish proof you are eligible to work in the country you are being hired? *

How did you hear about this opening? *

Will you relocate if the job requires it? *

How much are you willing to travel? *

Are you ok to work in a hybrid model work schedule? *

What is your desired salary/hourly rate? *

Please read and accept our privacy policy: *

https://clinchoice.com/privacy-policy/

Canada disclaimer: *

I certify all information provided in this employment application is true and complete. I understand any false information or omission may disqualify me from further consideration for employment and may result in my dismissal if discovered at a later date.

I authorize the investigation of any or all statements contained in this application and also authorize any person, school, current employer (except as previously noted), past employers and organizations’ names in this application to provide relevant information and opinions that may be useful in making a hiring decision. I release such persons and organizations from any legal liability in making such statements.

I understand if I am extended an offer of employment, it may be contingent upon my successfully passing a complete background and reference check. I hereby consent to any or all of these pre-employment test/screen/checks as a condition of employment, if required. I consent to the release of any or all medical information as may be deemed necessary to judge my capability to do the work for which I am applying.

I UNDERSTAND THIS APPLICATION OR SUBSEQUENT EMPLOYMENT DOES NOT CREATE A CONTRACT OF EMPLOYMENT NOR GUARANTEE EMPLOYMENT FOR ANY DEFINITE PERIOD OF TIME.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

Security Code *

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.