Medical Devices Engineer KATALYST HLS

Job Description:
Support new product design, development and implementation of delivery devices and Client injection tools/aids for biologic therapeutics.
Primary technologies include auto-injectors, patch infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges.
Execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various medical device designs.
This will include the execution of routine and ongoing R&D stability testing, design verification testing, complaint investigations and special testing requests.
Work with design engineers and the medical device development laboratory manager to identify, develop, implement, qualify and validate new testing equipment.


Clinical Trials Manager KATALYST HLS

Job Requirements:
BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
Seven or more years of relevant clinical trials experience, with at least four years of experience as a travelling CRA in the pharmaceutical industry
1+ years of trial management experience
Experience in CNS required
Travel required up to 20-25% of the time
Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
Demonstrated ability to work independently and in a team environment

Regulatory CMC specialist KATALYST HLS

Job Duties:
• Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
• Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers
• At least a Bachelor Degree required. Master’s Degree or PhD preferred


Senior Lead Data Manager KATALYST HLS

Job description:
Oncology Business Unit – Medical & Data Management. Data management serves as key subject matter expert on topics related to data management activities.
Contributions include, but are not limited: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management.
Position Summary:
The Senior Lead Data Manager (Sr. LDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community.
The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Oncology Data Management on the Core Study Team.


Statistician II KATALYST HLS

Primary Job Function:
Provide appropriate statistical input into study design and analysis of data. Ensures accuracy of programs and documents. Participates in statistical or process related presentations to customers.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Developing Statistical Plan:
Effectively communicates with project manager/CRA to understand to objectives of the study. Follows the appropriate operating procedure required for developing the statistical plan. Demonstrates the ability to research and provide appropriate statistical input to the study design. Using templates or examples, writes accurate statistical plans that are clear and understandable to the reviewers. Explains the rationale of the statistical methods to the project team.
Study Preparation:
Meets with CRA, R&D, Instrumentation scientists, department data collection programmers, and data entry to find the best way of capturing the dat


Clinical System Designer Katalyst HLS

Job Description:
Clinical Database Programmer with extensive data management experience in designing Oracle & Medidata Rave Clinical databases, creating Oracle Clinical validations, derivations and SAS views and 2 years of experience in Clinical Data Management as a Clinical Data Manager/ Analyst with expertise in designing Data specifications document, Edit Check Specifications, User acceptance Testing, External data Specifications, Data transfer specifications
Recognized for improving data review efficiency through proficient use of SQL and PL/SQL.
Has extensive understanding of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer system.
Overall knowledge on Discrepancy Management and communicating with team including External data reconciliation, SAE data checking.
Ensures clinical data within EDC is in quality to freeze and lock as appropriate for interim and statistical review
Experience with team


Clinical Regulatory Affairs Associate Katalyst HLS

This position interacts with multiple departments, as appropriate, involved in regulatory submissions.
The position, under supervision of the manager, makes FDA submissions, reviews requisite/critical documents and reports for completeness and suitability for submission.
Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.
Request missing and/or illegible pages, arrange for translations as needed.
Review regulatory documents to assure FDA requirements are met and are ready for submission.
Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies.