Medical Device Senior Regulatory Affairs Specialist KATALYST HLS

Job Description:
Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products.
Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products.
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines.
Provide CMC regulatory guidance to project teams and Global Regulatory team.


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.

Senior Quality / Regulatory Specialist Katalyst HLS

candidate who has strong experience in In-vitro Diagnostic (IVD) domain.
Candidate should have min of 6-8 yrs of experience and at least 5 yrs of experience in IVD domain
Should be knowledgeable on new EU regulations for IVDR


Senior Associate II, Records Methodology and Guidance katalyst HLS

Job Description:
Reporting to the Director, Records Methodology & Guidance and TMF, the Senior Associate II, Records Methodology and Guidance provides compliance and quality assurance support to all Biogen Global Development departments regarding the management of Global Development records throughout their lifecycle.
Additionally, the Senior Associate II works with the Senior Manager, Records Methodology & Guidance to support Global Development colleagues to develop, execute and measure records-related programs and internal controls to ensure that operations are conducted in compliance with applicable records management standards, and to ensure that Global Development and its personnel consistently adhere to the highest ethical standards and comply with applicable legal and regulatory records management requirements. He or she will support the communication and education of staff on records policies and governance.
The Senior Associate II will be a part of the organization’s record


Senior Data Manager katalyst HLS

Execute all DM start-up and data back lock activities, including the development and maintenance of
Edit check and custom listing specifications
Data Management Plan
CRF Completion Guidelines
Conduct user acceptance testing of data outputs per DM specifications
Organize and actively participate in CRF review meetings with the client
Perform comprehensive hands-on data review of all patient data through query management and/or manual review in accordance with SOPs and Work Instructions.
Analyzes study data metrics to continually assess both data quality and study progress
Track and provide project status updates to project managers for monthly project team meetings
Coordinate with Quality Assurance team to resolve any QA data issues


Senior Regulatory Submission Specialist Katalyst HLS

Department/Team Description:
Individual will work in the Packaging Development Group. The group is responsible for all packaging development related issues. Change control management, plant support as well as support of corporate initiatives are its primary function.
Position Summary:
The individual is responsible for issues associated with the packaging of solid, liquid, cream and ointment OTC and nutritional products manufactured at the Myerstown, PA location.
Responsibilities include, but are not limited to, package development, design and testing; identifying meaningful component specifications; qualifying components and packaging operations; troubleshooting commercial packaging operations; and implementation of quality and cost improvement programs.
Also, work within established guidelines to implement new packaging projects that have been initiated by the Marketing/I&D/Product Supply Departments in Morristown.



Functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock.
Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.
Responsible for the preparation and finalization of project and study related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
Responsible for the selection of investigators and study sites
responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to