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2,921 senior regulatory submissions manager jobs

Regulatory Submissions Manager - PLS

Shire Pharmaceuticals 100+ Reviews Lexington, MA

and delivery of regulatory submissions. The PLS Manager is also responsible for non-submission regulatory… authorities within required timeframes.  Lead activities for non-submission regulatory reporting on behalf… Shire Pharmaceuticals

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Senior / Clinical Trial Head – easy apply

Novartis Pharmaceuticals - Oncology East Hanover, NJ

of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission… . * Thorough knowledge of GCPs, clinical trial design, statistics, regulatory processes, and the full life… Novartis Pharmaceuticals - Oncology

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SENIOR RESEARCH DATA MANAGER

Brigham and Women's Hospital 100+ Reviews Boston, MA

. Participate in cleaning adjudicated data for clinical study reports, interim analyses, regulatory submissions… Job Title: SENIOR RESEARCH DATA MANAGER / 40 HOURS / DAY / BWH - TIMI STUDY GROUP… Brigham and Women's Hospital

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Senior Manager, Clinical Data Programming

Sunovion 89 Reviews Fort Lee, NJ

, procedures, industry standards, regulatory requirements and recommendations. Essential Functions Provide… ; Review/generate/validate electronic submission deliverables such as SDTM datasets, Define.XML, aCRF… Sunovion

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Senior Associate/Manager, Regulatory Affairs

Pharmacyclics, Inc. 57 Reviews Sunnyvale, CA

documents preparation, review and submission, and assist with compliance issues. Provide regulatory support… consistency, completeness and adherence to standards for all regulatory submissions. Participate… Pharmacyclics, Inc.

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Pharmacovigilance, Senior Specialist/Manager

Vertex Pharmaceuticals 100+ Reviews Boston, MA

with relevant regulatory guidelines. By virtue of their experience, the Senior Specialist is expected to provide… The Pharmacovigilance, (PV) Senior Specialist is responsible for performing Individual Case Safety… Vertex Pharmaceuticals

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PROJECT MANAGER

Brigham and Women's Hospital 100+ Reviews Boston, MA

, including serious adverse event reporting, and for ensuring all regulatory requirements are met in all… . 8. Identifies, organizes, and ensures accurate completion of required regulatory documents from… Brigham and Women's Hospital

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Senior Manager, Biostatistics

Sunovion 89 Reviews Marlborough, MA

for regulatory submissions. This typically involves oversight of internal or external teams of biostatisticians… that lead to comprehensive statistical/clinical study reports suitable for regulatory submissions. 2… Sunovion

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GRANTS COORDINATOR

Brigham and Women's Hospital 100+ Reviews Boston, MA

Investigators (PIs), the Grants Administrator, the Senior Grants Manager, the Director of Research Management… of expenditures with Grants Administrator and Senior Grants Manager. 3. Request purchase orders, submit… Brigham and Women's Hospital

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Manager/Senior Manager, CMC Regulatory Affairs

Pharmacyclics, Inc. 57 Reviews Sunnyvale, CA

and lead/coordinate the process for compiling CMC section of regulatory submissions. Key… submissions. Acquires and maintains current knowledge of applicable regulatory requirements and scientific… Pharmacyclics, Inc.

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Senior Manager, Quality Assurance

Sunovion 89 Reviews Marlborough, MA

of regulatory submissions for IND’s, CTA’s, NDA’s, etc. as assigned. • Assist in product release activities… will be responsible for compliance to regulatory filings and therefore must have experience in a Quality Assurance… Sunovion

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Senior Medical Director

Pharmacyclics, Inc. 57 Reviews Sunnyvale, CA

authority interactions with little or no supervision from his/her manager Works with Regulatory… partners and regulatory authorities. Key Accountabilities/Core Job Responsibilities: Plays… Pharmacyclics, Inc.

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Senior Clinical Analyst

Healthfirst (New York) 100+ Reviews New York, NY

will also assist in the annual HEDIS, QARR and QRS reporting functions alongside the Senior Manager… : The Senior Clinical Analyst is responsible for the maintenance and delivery of informatics that produce… Healthfirst (New York)

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Senior Associate Contract Manager Provider Affairs Rockville MD

Kaiser Permanente 100+ Reviews Rockville, MD

DescriptionThe Senior Associate Contract Manager for Provider Affairs, working under the direction… to the contract manager, development of the counter proposal to be evaluated and approved for submission Kaiser Permanente

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Corporate- (Senior) Tax Manager

Charles River Associates 89 Reviews Boston, MA

, demanding workplace. The (Senior) Tax Manager is a key member of the financial administration… of compensation plans is an important aspect of the role in which the (Senior) Tax Manager will be involved… Charles River Associates

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