Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Associate Scientist II
Posted: 06/05/2023
2023-06-05
2023-07-06
Employment Type:
Contract
Job Category: Scientific
Job Number: 565359-1
Is job remote?: Yes
Country: United States
Job Description
• Writes clinical study reports, Post-Market Clinical Follow-up (PMCF) Plans and Reports, and Clinical Development Plans (CDPs) by evaluating scientific data and staying abreast of current clinical practice.
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• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with regulatory agencies as needed and will use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
•
• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
•
• Interacts with various study support groups cross-functional teams to assist in clinical strategy, the development of plans, reports and project deliverables. Is responsible for providing clinical feedback for other cross-functional deliverables.
•
• Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager.
•
• Conducts team meetings, drafting and sending routine correspondence (e.g., timelines, meeting minutes) and/or by giving presentations to senior staff on project status. Creates, manages, or participates in clinical study or clinical evaluation timelines.
*CO/NYC candidates might not be considered
•
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with regulatory agencies as needed and will use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
•
• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
•
• Interacts with various study support groups cross-functional teams to assist in clinical strategy, the development of plans, reports and project deliverables. Is responsible for providing clinical feedback for other cross-functional deliverables.
•
• Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager.
•
• Conducts team meetings, drafting and sending routine correspondence (e.g., timelines, meeting minutes) and/or by giving presentations to senior staff on project status. Creates, manages, or participates in clinical study or clinical evaluation timelines.
*CO/NYC candidates might not be considered
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Embrace the career journey in Lake Bluff, Illinois! Nestled along the shores of Lake Michigan, Lake Bluff offers a picturesque backdrop for both work and play. From the vibrant arts scene featuring the stunning Ragdale Foundation to the renowned Citadel Theatre, this area exudes creativity and culture. Savor the local cuisine at The Silo Restaurant, or take a stroll through the scenic Open Lands natural areas for a relaxing getaway. With proximity to Chicago's professional sports teams and venues, Lake Bluff provides the perfect balance of small-town charm and big-city excitement. Explore our job opportunities today and embark on a rewarding career in this enchanting region!
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