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Regulatory Affairs Project Manage Jobs

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Senior Manager, Regulatory Affairs

Sagent Pharmaceuticals

Department: Regulatory Affairs Classification: Exempt Reports To: Sr. Director, Regulatory Affairs Job Summary / Overview: Serves as the primary regulatory interface with FDA, Partners and internal team. Ensure the business needs for the assigned products are met by

3/19/2013  Schaumburg, IL  Save This Job

Associate Director/Director, Regulatory Affairs - SM001

Relypsa

DEPARTMENT: Regulatory Affairs Relypsa will soon be located in Redwood City and we are hiring! Relypsa is seeking a reliable, self-motivated professional for the position of Associate Director/Director, Regulatory Affairs. This position will support Regulatory Affairs in the

3/25/2013  Santa Clara, CA  Save This Job

Sr. Associate, Regulatory Affairs

Sagent Pharmaceuticals

Department: Regulatory Affairs Classification: Exempt Reports To: Sr Manager, Regulatory Affairs AND/OR Associate Director Regulatory Affairs Job Summary / Overview: The role is primarily responsible for the management and support of Pre and Post approval regulatory

3/19/2013  Schaumburg, IL  Save This Job

Manager, Regulatory Affairs, Labeling

Sagent Pharmaceuticals

Department: Regulatory Affairs Classification: Exempt Reports To: Associate Director Regulatory Affairs Job Summary / Overview: This role is primarily responsible for managing the development of labeling and managing key labeling systems and processes to support labeling

3/19/2013  Schaumburg, IL  Save This Job

Sr. Manager, Quality Assurance and Regulatory Affairs

Promega

Tracking Code 1864 Job Description JOB OBJECTIVES: Responsible for all aspects of the PBS quality system, encompassing product quality as well as the quality of processes and services throughout the organization. ACCOUNTABILITIES: ? Accountable for the development and

4/29/2013  Sunnyvale, CA  Save This Job

Senior Manager/Associate Director, Regulatory Affairs (13-120)

FibroGen

Description: Review, provide comments on, and prepare documents for submission to FDA and international regulatory authorities including protocols, investigator brochures, nonclinical and CMC amendments, and other regulatory documents. Lead teams on the preparation, review and

5/16/2013  San Francisco, CA  Save This Job

Project Manager

Outcome Software, Inc.

Description Purpose: With supervision from Management, the Project manager (PM) role is to implement agreed upon strategies for the management of national or international internet-based outcome studies with pre-specified timelines and budgets. The PM leads the project team and

3/30/2013  Cambridge, MA  Save This Job

Project Manager

Outcome Software, Inc.

Description Purpose: With supervision from Management, the Project manager (PM) role is to implement agreed upon strategies for the management of national or international internet-based outcome studies with pre-specified timelines and budgets. The PM leads the project team and

3/30/2013  Cambridge, MA  Save This Job

Head of Medical Writing

Anacor Pharmaceuticals, Inc.

Job Summary Head of Medical writing will manage a Medical Writing group of contract medical writers and develops, manages, and executes medical writing activities for projects in accordance with applicable regulatory and Anacor requirements. Assumes primary responsibility for

4/9/2013  Palo Alto, CA  Save This Job

Clinical Trial Manager

Theraclone Sciences

Theraclone Sciences is a Seattle-based biotechnology company focused on the development of novel, therapeutic, human-antibodies for the treatment of infectious disease and cancer, and as a basis for vaccine development. Theraclone is a privately held company with venture

4/3/2013  Seattle, WA  Save This Job

Medical Director - Oncology

KaloBios Pharmaceuticals

Reports to: Chief Medical Officer The Medical Director - Oncology will report to the Chief Medical Officer and will provide medical direction for the Oncology clinical programs at KaloBios. Lead the clinical strategic efforts for the oncology programs Lead and develop all

4/16/2013  South San Francisco, CA  Save This Job

Senior Manager, Clinical Operations

Acceleron Pharma

About Acceleron: Founded in 2003, Acceleron Pharma, Inc. is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. We have internally discovered and developed 4 products

4/10/2013  Cambridge, MA  Save This Job

Regional Medical Director - West

Horizon Pharma

Description Position Summary: The Regional Medical Director (RMD) will serve as a scientific liaison to the medical/scientific community and will be responsible for establishing, developing and maintaining relationships with prominent experts and clinicians throughout the US. The

5/2/2013  Palo Alto, CA  Save This Job

Regional Medical Director

Horizon Pharma

Description Position Summary: The Regional Medical Director (RMD) will serve as a scientific liaison to the medical/scientific community and will be responsible for establishing, developing and maintaining relationships with prominent experts and clinicians throughout the US. The

5/2/2013  Deerfield, IL  Save This Job

General Counsel

KaloBios Pharmaceuticals

Reports to: Chief Executive Officer The General Counsel will report to the Chief Executive Officer and will oversee all in-house and external legal function and groups at Kalobios. The General Counsel is responsible for overseeing the legal function at the company and will be

4/16/2013  South San Francisco, CA  Save This Job

Medical Writer

CoreLab Partners

Overview: Main responsibility involves reviewing protocols, writing Charters and Imaging Manuals, and reviewing the technical and medical components of study-related documents. Responsibilities: Author Independent Review Charters (Charters), Imaging Manuals (if applicable)

2/5/2013  Princeton, NJ  Save This Job