Medical Writer - I
Medical Writer - I
Posted on :
13-10-2024
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Job Description
Description:
Job Title: Clinical Trial Education and Literature Review Specialist
Job Summary:
We are seeking a detailoriented and analytical Clinical Trial Education and Literature Review Specialist to support the development and submission of clinical trial education materials to the Promotional Review Committee (PRC). This role is also responsible for conducting comprehensive literature reviews to assess the landscape of new and emerging medical indications. The ideal candidate will work closely with crossfunctional teams including medical affairs regulatory and marketing to ensure that all materials are accurate compliant and aligned with the latest medical research.
Key Responsibilities:
Develop organize and submit clinical trial education materials to the Promotional Review Committee (PRC) for review and approval ensuring compliance with regulatory and company guidelines.
Provide ongoing support during the PRC review process addressing feedback revising materials and ensuring timely approval.
Conduct thorough literature reviews to gather and analyze data on new medical indications treatment trends and advancements in the field.
Collaborate with crossfunctional teams (Clinical Development Medical Affairs Regulatory Marketing etc.) to ensure educational materials align with clinical trial objectives and reflect the latest medical information.
Monitor and stay current on industry trends new therapies and scientific advancements that may impact clinical trial materials or strategic positioning.
Synthesize complex medical and scientific information into clear concise educational content for internal and external audiences.
Assist in the development of communication strategies that effectively educate healthcare professionals about clinical trials investigational products and new medical indications.
Ensure all educational materials are updated and consistent with the latest clinical trial data and regulatory requirements.
Maintain a comprehensive database of clinical trial education materials and literature review findings for easy access and future reference.
Qualifications:
Bachelor s degree in life sciences clinical research healthcare or a related field (Advanced degree preferred).
24 years of experience in clinical research medical affairs regulatory affairs or medical communications.
Experience preparing materials for Promotional Review Committees or similar review bodies.
Strong understanding of clinical trial processes regulatory requirements and promotional guidelines (e.g. FDA EMA).
Demonstrated experience conducting literature reviews including the ability to analyze
Fully remote role.EST is preferred
Job Summary:
We are seeking a detailoriented and analytical Clinical Trial Education and Literature Review Specialist to support the development and submission of clinical trial education materials to the Promotional Review Committee (PRC). This role is also responsible for conducting comprehensive literature reviews to assess the landscape of new and emerging medical indications. The ideal candidate will work closely with crossfunctional teams including medical affairs regulatory and marketing to ensure that all materials are accurate compliant and aligned with the latest medical research.
Key Responsibilities:
Develop organize and submit clinical trial education materials to the Promotional Review Committee (PRC) for review and approval ensuring compliance with regulatory and company guidelines.
Provide ongoing support during the PRC review process addressing feedback revising materials and ensuring timely approval.
Conduct thorough literature reviews to gather and analyze data on new medical indications treatment trends and advancements in the field.
Collaborate with crossfunctional teams (Clinical Development Medical Affairs Regulatory Marketing etc.) to ensure educational materials align with clinical trial objectives and reflect the latest medical information.
Monitor and stay current on industry trends new therapies and scientific advancements that may impact clinical trial materials or strategic positioning.
Synthesize complex medical and scientific information into clear concise educational content for internal and external audiences.
Assist in the development of communication strategies that effectively educate healthcare professionals about clinical trials investigational products and new medical indications.
Ensure all educational materials are updated and consistent with the latest clinical trial data and regulatory requirements.
Maintain a comprehensive database of clinical trial education materials and literature review findings for easy access and future reference.
Qualifications:
Bachelor s degree in life sciences clinical research healthcare or a related field (Advanced degree preferred).
24 years of experience in clinical research medical affairs regulatory affairs or medical communications.
Experience preparing materials for Promotional Review Committees or similar review bodies.
Strong understanding of clinical trial processes regulatory requirements and promotional guidelines (e.g. FDA EMA).
Demonstrated experience conducting literature reviews including the ability to analyze
Fully remote role.EST is preferred
Additional Details
- Managers Requested Bill Rate : (No Value)
- Onsite Offsite : Offsite
Employment Type
Full Time
Key Skills
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