Encapsulation Systems Incorporated Work Values

Daily Duties at Encapsulation Systems Incorporated:

Vice President, Intellectual Property, and Clinical Director: Responsibilities included regulatory and clinical oversight for PK and Ph I clinical trials for a Class III transdermal medical device that used ultrasound to deliver insulin to patients with Type 2 diabetes. Duties included protocol design, protocol writing, clinical investigations, creation of investigator meetings, attendance at investigator meetings, work order creation, management of trial medications and the monitoring of patients according to GCP guidelines. Also supervised and trained clinical, marketing, engineering, executive and administrative staff on GCP guidelines and our company SOPs. I was responsible for the timely and compliant progress of clinical trials. I also worked with a small medical device CRO partner as well as two separate IRBs. I provided clinical and regulatory trial oversight in San Antonio, TX and Philadelphia. I collaborated with CRO QA/QC personnel to enforce our clinical regulatory requirements and GCP Adverse Event reporting. I supported principal investigators to correctly gather clinical information for submission to our CRO data management team. I asisted internal Project Managers to achieve milestones and stay on track with designated clinical endpoints. Worked with internal Business Development and Executive teams to review master service agreements, external partnership agreements and vendor agreements. Created a scientific advisory board that helped support our clinical program and provide clinical, regulatory and scientific direction. Acted as a liaison to the FDA preparing and submitting various IDE’s and 510k’s. Separately supported CE self-certification. Also worked with our Engineering team to review engineering change orders, deviation reports and rework procedures. Thorough knowledge of device and pharmaceutical cGMPs, cGLPs, and cGCPs as well as 510ks, PMA, INDs, NDAs and FDA guidances.

What they like about Encapsulation Systems Incorporated:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

intellectual property, biotech, device, regulatory affairs, corporate integrity agreements, pharmaceutical, litigation, mediation, negotiations, contracts, partnerships, licensing agreements, alliances, FDA, compliance, data discovery, electronic data collection, data analysis

Skills

Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Leadership , Patent Searches, IP Negotiations and Litigation, Biosimilar 505(b)(2) and Generic IP Analysis, In-Licensing and Out-Licensing Deal Making

These are some of the questions we asked our climbers about their experiences with Encapsulation Systems Incorporated: