Senior Medical Writer - Regulatory Submissions Lead
Integrated Resources Inc.
A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables. Ideal candidates will possess a strong scientific background and experience in medical writing or pharmaceutical development. #J-18808-Ljbffr Integrated Resources Inc.
$70k - $130k
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...Job Title: Sr. AI Driven Innovations Lead Location: Morristown, NJ About... ...clinical data processing, analysis, and regulatory submission, ensuring alignment with Sanofi's... ...extraordinary Better is out there. Better medications, better outcomes, better science. But...SeniorRegulatoryTemporary workWork experience placementFlexible hours- ...peers and cross-functional teams. Maintain solid knowledge of Regulatory Agency organizations. Apply knowledge and experience to increasingly... ...stakeholder timelines and objectives. Develop and communicate submission strategies for the project team, including strategies for...SeniorRegulatoryWork at office
- ...Description- • The Author will provide medical documentation summarizing risks... ...and efficacy, responses to regulatory questions, risk management... ...complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external...RegulatoryFor contractors
- Contributes to development of global regulatory documentation strategy and execution of tactics. Conceptualizes and develops medical communications for message-driven, concise... ...Coordinates medical writing/regulatory submission progress against global regulatory strategic...SeniorRegulatoryLocal areaRemote work
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Shionogi Inc. is seeking a Director/Senior Director of COA Strategy in Florham Park, NJ. This role focuses on developing COA strategies... ..., providing leadership to cross-functional teams, and ensuring regulatory acceptability of endpoints. The ideal candidate will possess a...SeniorRegulatory$140k - $155k
...ideal candidate will have extensive experience in operations and regulatory compliance, driving effective reporting practices to identify... ...frameworks, conducting data analyzes, and presenting findings to senior management. The compensation is competitive with a range of $14...SeniorRegulatory- Scorpion Therapeutics in Madison, New Jersey, seeks a Senior Manager, Full Stack Engineer to support Global Regulatory Sciences in an AI-first agile product environment. This role is pivotal for the end-to-end build and management of AI-native technology assets. Qualified...SeniorRegulatoryFlexible hours
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$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge,... ...Project Strategy (GRPS), Global Submission Strategy, and core product... ...of the key outcomes to senior management Advances the organization... ...Better is out there. Better medications, better outcomes, better...Regulatory- Barclays Services Corp. is seeking a Regulatory Reporting Lead, AVP in Whippany, NJ. This role is crucial for managing Regulatory Reporting and Tax submissions. The successful candidate will maintain application stability and collaborate with stakeholders to ensure efficient...Regulatory
- ...Senior Director, Head of Biometrics About the Company Respected biopharmaceutical... ...for clinical development and global regulatory submissions. The successful candidate will be... ...-making. Key responsibilities include leading the biometrics function, serving as a...SeniorRegulatory
- ...that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a... ...Instagram , X and YouTube. Job Description The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately...SeniorRegulatoryFull timeTemporary workWork at officeLocal areaRemote work
- ...week) Our client is seeking an experienced Medical Writer to support the preparation of clinical and regulatory documents across multiple development programs.... ...supporting clinical development and regulatory submission activities. The ideal candidate will possess strong...RegulatoryFull timeContract workWork at office
$188.72k - $235.9k
Our Team, Your Impact The Senior Director - Strategic Sourcing Lead is responsible for leading and strengthening... ...reflect business requirements, regulatory standards, and risk considerations... ...Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription...SeniorRegulatoryContract workLocal areaFlexible hours$140k - $165k
...Description Job Description Senior Manager CMC Regulatory A Partner to Actalent is... ...CMC Regulatory Affairs to lead regulatory strategy and... ..., drive high‑quality submissions, and collaborate effectively... ...include the following: • Medical, dental & vision • Critical...SeniorRegulatoryPermanent employmentTemporary work$119.7k - $222.3k
...program-level activities (incl. submission and post- marketing... ...Your Key Responsibilities: * Lead statistical programming activities... ...clinical study reports (CSRs), regulatory submissions/interactions,... ...disabilities. If, because of a medical condition or disability, you...SeniorRegulatoryWork experience placementRemote work
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