Manager, Regulatory Affairs

 

Overview 

Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture. …

QC Supervisor

This role provides Supervisory oversight of the analyses, inspection, and tests of products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing/incoming, to ensure quality standards and compliance with company standards, customer and governmental regulatory requirements, and tolerance specifications for the chemical or physical property.…

Labware LIMS System Admin

LabWare LIMS Sr Sys Admin

This role primarily requires:

1A. Basic BA skills are a nice to have, but will not be required to gather requirements, must have script clean up experience, knowledge of off-the-shelf vs custom Labware changes to guide business in the appropriate path forward, and be able to implement changes independently to existing functionalities as well as implement new applications within Labware. …

Labware LIMS System Admin

LabWare LIMS Sr Sys Admin

This role primarily requires:

1A. Basic BA skills are a nice to have, but will not be required to gather requirements, must have script clean up experience, knowledge of off-the-shelf vs custom Labware changes to guide business in the appropriate path forward, and be able to implement changes independently to existing functionalities as well as implement new applications within Labware. …

Respiratory Medical Science Liaison/Sr. MSL

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world.…

Sr. Director, R&D

This is an important, high profile and visible role and requires an individual with outstanding communication and cross-functional leadership skills, as well as the ability to build strong relationships with key stakeholders in Clinical and other relevant functions within MedImmune and external academic collaborators.…

Global Principal Clinical Scientist

The position holder is responsible for both scientific input to clinical development strategies for early pipeline projects, acting as a liaison between Research, clinical Development Therapeutic Area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes the Early Development Plan, study synopses and protocols, Investigator’s Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications 
Main Responsibilities and Accountabilities 
1 Contribute, in collaboration with Research, the scientific rationale for clinical development strategies for early pipeline programs.…

Temporary Technical Writer – Analytical

Overview 

3 Month Assignment. 

Prepare documentation to include specifications, method verification/validation reports, method transfer reports, and characterization reports as and when needed in appropriate format required by regulatory affairs. 

Review, revise and draft Standard Operating Procedure documents. 

Working efficiently to setup Active Pharmaceutical Ingredients (API) as well as Finished Product (FP) specification based on API manufacturers drug master file (DMF), United state Pharmacopeia (USP) monograph and ICH guidelines with the help of group leader and scientist. …

Manager, Clinical Trial Disclosure and Transparency

The Manager, Clinical Trial Disclosure and Transparency is responsible for executing CSL disclosure and transparency activities as directed, including clinical trials registration and summary results disclosure, in all regions across the global CSL organization according to CSL policy. He/she will manage the trial disclosure system in collaboration with the Senior Manager, Clinical Trial Disclosure and Transparency 
The incumbent will also contribute to the development and maintenance of procedures and standards that will support current and future global clinical trial disclosure requirements. …

Principal Scientist/Director and Team Leader, Oncology Bioscience

Principal Scientist/Director and Team Leader, Oncology Bioscience – Target identification/validation and early project leader 
At AstraZeneca , we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing.…

Science Associate Director/Science Director

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.…

Director- Clinical Development & Research (Multiple positions) Job

Purpose
Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.

Relationships
Reports to the Executive Director- Clinical Development & Research- Diabetes & Obesity.…

Associate Scientist II – Lung Regeneration & Repair

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to collaborate with renowned scientists to find the targets which are fundamental derivers of human disease. As one of the world's premier biotechnology companies, our mission is centered on making a difference in people's lives every day. …

Post Doctoral Fellow – Human Lung Stem Cells and Regeneration

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to collaborate with renowned scientists to find the targets which are fundamental derivers of human disease. As one of the world's premier biotechnology companies, our mission is centered on making a difference in people's lives every day. …

Modelling and Simulation, Associate Principal Scientist

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.…

Document Management Technician

Overview 
People are at the center of who we are and what we do. 
Are you seeking… 

– A culture defined with the help of your voice? 
– Recognition for your talent and continued growth opportunity? 
– Upfront tuition assistance (eligible day one of employment)? …

Director, Tumor Strategy

An opportunity to use your scientific knowledge and strategic analysis skill to influence decisions that will have a direct impact on patients' lives! 
At AstraZeneca, we have created and strategically acquired one of the most promising Oncology pipelines in the industry. …

Clinical Scientist, Oncology

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century .…

Manufacturing Associate, Drug Product Primary

Overview 
People are at the center of who we are and what we do. 
Are you seeking… 

– A culture defined with the help of your voice? 
– Recognition for your talent and continued growth opportunity? 
– Upfront tuition assistance (eligible day one of employment)? …

Senior Systems Analyst, LIMS

B. Braun Medical Inc.

Requisition ID 2017-11025
Company B. Braun Medical Inc
# of Openings 1
Job Locations US-PA-Bethlehem
Category Information Technology
Position Type Regular Full-Time
Shift 8 am to 5 pm
Site Corporate/Sales/ B. Braun of Canada/ BIS/ CeGat

Overview

With a nationwide sales team and several manufacturing locations, B.…