- Deloitte (Philadelphia, PA)
- …Specialist (CIS) (Security Incident Response/Vulnerability Response), Certified Technical Architect ( CTA ), CISSP, CISM, or CISA certification a plus + Demonstrating ... flexibility in prioritizing and completing tasks, including a willingness to learn and work in a disciplined and collaborative environment. + Maintaining a "self-starter" mindset, and the ability to listen to clients, managers, and peers, take strategic… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA , NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong ... oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. -… more
- Lilly (Philadelphia, PA)
- …Drive development and execution of CMC activities in support of IND, CTA and BNDA/MAA submissions. + Partner closely with Development and Manufacturing Operations ... teams to oversee technical transfer, process validation, stability, and comparability planning. + Maintain accountability for CMC program timelines, budget, resource allocation, and key deliverables. + Serve as the primary interface between CMC and global… more
- Deloitte (Pittsburgh, PA)
- …may be available. Preferred Qualifications: + ServiceNow Certified Technical Architect ( CTA ) + Experience with ServiceNow Security Operations or Governance, Risk, ... and Compliance modules + Experience with security operations, incident response, or vulnerability management + Knowledge of cybersecurity frameworks (NIST, ISO 27001, etc.) + Experience with integration technologies and API development + Strong understanding… more
- Deloitte (Pittsburgh, PA)
- …to Report processes + Experience with Intercompany, Consolidations, Multibook accounting, CTA Analysis, FX variances, and/or Financial Reporting + You should reside ... within a commutable distance of your assigned office with the ability to commute daily, if required + You can expect to co-locate on average 3 times a week with variations based on types of work/projects and client locations + Ability to travel up to 50%, on… more
- University of Pennsylvania (Philadelphia, PA)
- …slides, MOPs, DSMB charter, CRFs, SOPs. Provide assistance with IND/IDE/ CTA exemption determinations. + Assist/conduct pre-award finance activities (MRA/MCA ... development, CTMS registration, RBN, driving contract timelines, budgeting input or development, grant writing assistance); and/or post award finance activities (invoicing, billing review). + Staff supervision: Assist and train direct and/or indirect research… more
- CDM Smith (Wayne, PA)
- …testing, installation, and construction phase services, preferably with clients like CTA , Metra and/or similar transit agencies nationwide. -Experience managing and ... delivering design projects from initiation through final design. -Working knowledge of Revit and AutoCAD. -Ability to present in front of large groups. -Task leader, discipline leader, or project management experience, including development of project… more
- J&J Family of Companies (Spring House, PA)
- …goals with timely, high-quality deliverables (eg, Investigator's Brochures, IND/ CTA /NDA nonclinical modules, briefing books, health authority responses) across ... all programs and development phases. + Partner with Nonclinical Safety, Drug Metabolism and Pharmacokinetics, Bioanalytical, and Pharmacology Leads and other SMEs to develop clear storytelling in submissions by positioning key messages, providing robust… more
- Deloitte (Philadelphia, PA)
- …the work you do and the clients and industries/sectors you serve. Preferred: + CMA/ CTA certification + 4+ years of experience in generating new client business + ... Experience collaborating and developing client relationships, developing new opportunities with clients, and identifying engagement follow-on opportunities for continuous improvement + Business Development experience selling 3+ year deals and offering… more
- Merck (West Point, PA)
- …frameworks applicable to radiopharmaceuticals (GMP for radiopharmaceuticals, IND/ CTA requirements, radiation safety/compliance). Prepare and contribute PET-specific ... scientific content for regulatory filings, including IND submissions. + **Partner and site management:** Coordinate with CROs, CDMOs, and clinical sites to support cGMP manufacturing logistics and clinical supply/distribution for radiopharmaceuticals. Manage… more