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Medical Reviewer/Safety Reviewer III (Remote)
Contract: North Chicago, Illinois, US
Salary Range: 40.00 - 45.00 | Per Hour
Job Code: 364033
End Date: 2025-08-28 Days Left: 27 days, 3 hours left
Apply
Description: Title: Medical Reviewer/Safety Reviewer III (Remote) The primary responsibilities would include
Medical Review for label, clinical data and disease state Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews Aligns medical education and scientific initiatives with Scientific Communication Platform Responsibilities:
With oversight, contributes to the development of the therapeutic area strategy. Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with the indication or asset's strategic plan. Leads conference planning and execution. Represents at external meetings including investigator meetings, scientific association meetings, etc. May be responsible for Medical Review (MR) training for on label, clinical data and disease state. Responsible for managing budget for assigned projects including consulting and vendor management. Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews. Aligns medical education and scientific initiatives with the Scientific Communication Platform. Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials. Contributes to all launch readiness reviews/planning. Top 3-5 skills, experience or education required for this position (in order of priority):
Ability to work independently, with the potential to quickly onboard, because candidate has;
o Previous experience performing medical review of both medical and promotional materials o Previous experience reviewing in Veeva PromoMats and/or MedComms (CRM knowledge) o Previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new disease states.
Ability to share concisely and clearly the rational for review decisions with broader Commercial and Medical Teams. Qualifications:
Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred. 3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required. Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals). Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations Good understanding of Medical Affairs principles, study design and publications. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred. Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc. Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills. Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships. Pay Range:
$40-45/Hr Job Requirement
Medical Reviewer Safety Reviewer label clinical data Scientific Communication IIS Medical Information CRM Veeva PromoMats promotional material MedComms MS PhD MD/DO PharmD NP MSN CDER CBER FDA CFR ISO HIPPA PhRMA code GCP Medical Affairs Reach Out to a Recruiter Recruiter Email Phone Sanjay Rawat sanjay.rawat@collabera.com
Apply Now
Home Search Jobs Job Description
Medical Reviewer/Safety Reviewer III (Remote)
Contract: North Chicago, Illinois, US
Salary Range: 40.00 - 45.00 | Per Hour
Job Code: 364033
End Date: 2025-08-28 Days Left: 27 days, 3 hours left
Apply
Description: Title: Medical Reviewer/Safety Reviewer III (Remote) The primary responsibilities would include
Medical Review for label, clinical data and disease state Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews Aligns medical education and scientific initiatives with Scientific Communication Platform Responsibilities:
With oversight, contributes to the development of the therapeutic area strategy. Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with the indication or asset's strategic plan. Leads conference planning and execution. Represents at external meetings including investigator meetings, scientific association meetings, etc. May be responsible for Medical Review (MR) training for on label, clinical data and disease state. Responsible for managing budget for assigned projects including consulting and vendor management. Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews. Aligns medical education and scientific initiatives with the Scientific Communication Platform. Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials. Contributes to all launch readiness reviews/planning. Top 3-5 skills, experience or education required for this position (in order of priority):
Ability to work independently, with the potential to quickly onboard, because candidate has;
o Previous experience performing medical review of both medical and promotional materials o Previous experience reviewing in Veeva PromoMats and/or MedComms (CRM knowledge) o Previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new disease states.
Ability to share concisely and clearly the rational for review decisions with broader Commercial and Medical Teams. Qualifications:
Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred. 3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required. Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals). Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations Good understanding of Medical Affairs principles, study design and publications. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred. Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc. Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills. Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships. Pay Range:
$40-45/Hr Job Requirement
Medical Reviewer Safety Reviewer label clinical data Scientific Communication IIS Medical Information CRM Veeva PromoMats promotional material MedComms MS PhD MD/DO PharmD NP MSN CDER CBER FDA CFR ISO HIPPA PhRMA code GCP Medical Affairs Reach Out to a Recruiter Recruiter Email Phone Sanjay Rawat sanjay.rawat@collabera.com
Apply Now