973 Java Developer jobs in Norristown,PA

Minimum of 4-year undergraduate degree
5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry
Experience with EMA, MHRA and other local European agencies preferred
Understanding of GxP systems and Quality principles
Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies
Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications
Excellent communication, time management and project management skills
Continuous quality improvement mindset and attention to details
Can do attitude, flexibility, and mental agility
Key Experience, Skills and Knowledge listed under Requirements

KPMG

Philadelphia, PA 19019

Actalent

Horsham, PA 19044

Advanced Technology Services

Merchantville, NJ 08109

Orbis

Philadelphia, PA 19120

Must be a US Citizen with a Secret Security Clearance
High School Diploma or equivalent.
Target Experience: Five (5) years of relevant QA work experience.
The contractor employee shall have experience in performing various quality assurance functions such as Quality Planning, Inspection and Testing, Auditing, review of Objective Quality Evidence, and Quality Management, and/or services that are essential to the safe operations of United States (U.S.) Submarines and Naval Level I Material Program.
They shall also have experience in supporting the development procedures and work instruction for governmental approval in support of departmental Quality Programs.
The contractor shall be proficient in reading and understanding complex electromechanical engineering drawings/blueprints.
Knowledge of Quality Systems that meet MIL-I-45208/ISO 9001 standards.
Effective communicator (oral and written).
Experience with Adobe, and Microsoft Office Suite programs.
Expected to meet the following daily physical demands:
• Standing for excessive periods of time.
• Climbing ladders.
• Subjected to loud environment.
• Subjected to fluctuating climate temperatures.
• Squatting and ducking to maneuver through congested spaces.