Belsy Daniel
Philadelphia,PA
Summary
Experienced professional with over 7 years in the pharmaceutical industry specializing in compliance and learning management systems. Proven track record in managing training programs for large teams and ensuring regulatory compliance. Skilled in project management and team collaboration to streamline training operations. Committed to leveraging expertise to enhance learning systems and drive business success.
Overview
11
11
years of professional experience
Work History
Precision Medicine Project Manager
Johnson & Johnson (Contracted Through LabConnect)
05.2025 - Current
- Provide project management support to cross-functional Translational Research (TR) and Companion Diagnostics (CoDx) teams.
- Manage multiple stakeholders and teams in a fast-paced, cross-functional environment, ensuring alignment across the drug development lifecycle.
- Drive agendas, capture key actions and decisions, track task completion, and facilitate communication within TR teams.
- Support cross-functional planning, budgeting, and resourcing while managing Key Event Maps (KEMs) that outline timelines and costs.
- Oversee biomarker plan creation and updates, and support delivery of Translational Research status updates.
- Lead and support sub-team meetings, enable proactive risk management, and ensure clarity on team roles and responsibilities.
- Collaborate in DAS strategy discussions and drive TR teams toward Think Tank 2 (TT2) sessions for early budget reads.
- Coordinate budget forecasting and planning with the BDO, creating accurate line items and ensuring financial alignment.
- Utilize MS Teams, SharePoint, OneNote, Project, and Portfolio Dashboards for collaboration, tracking milestones, and maintaining team visibility.
- Contribute to KPI reporting and data visualization through systems like Tableau, Beacon, V6, UCT, and VizCafe.
- Contracted through LabConnect
Founder/ President
Independence Billboards
04.2023 - Current
- Developed and presented business proposals to secure partnerships and drive business growth.
- Enhanced marketing expertise by staying informed on industry trends, leading to effective marketing campaigns.
- Analyzes target audiences to design effective and impactful marketing campaigns based on client needs.
- Ensures all advertisements comply with relevant laws and industry guidelines.
- Managed financial oversight by tracking expenses and revenue, ensuring financial stability.
- Proactively identifies potential challenges and implements strategies to mitigate risks.
Manager, Global Patient Safety Evaluation, Standards and Training
Takeda Pharmaceutical Company Limited (Contracted
12.2021 - 04.2022
- Assigned and managed training sessions for new hires.
- Monitored and ensured training compliance using the Learning Management System (LMS).
- Collaborated with document authors to update, revise, or retire integrated documents within LEADs Document Management System (DMS) and VEEVA.
- Assisted in updating and retiring non-integrated documents in legacy systems, providing writing support as needed.
- Reviewed GPSE job roles and Learning Plans (LP), working with functional area heads to maintain accurate and up-to-date training requirements.
- Responded to inquiries in the global training mailbox, providing guidance and support.
- Contracted through Real Staffing
Learning & Development Specialist
Merck & Co., Inc.
03.2020 - 11.2021
- Designed, managed, and maintained Good Manufacturing Practice (GMP) job skills training, curricula, and job codes, ensuring compliance with internal and external regulations in SAP SuccessFactors LMS.
- Partnered with area leaders and Subject Matter Experts (SMEs) to conduct learning needs analyses, identify performance gaps, and develop training solutions based on adult learning principles.
- Oversaw and maintained 30+ training materials, conducting 3-year reviews and updates to align with business process changes.
- Managed and maintained 25+ comprehensive job skills curricula to support training compliance and workforce development.
- Provided performance consulting, developing GMP training programs to ensure regulatory adherence and continuous improvement.
- Led the review and update of 50+ training materials, ensuring alignment with evolving business processes.
- Developed and implemented strategies to address compliance gaps, mitigate risks, enhance performance, and maintain product quality.
- Supported internal and external audits, ensuring training and documentation compliance.
- Collaborated with cross-functional teams to streamline processes and improve training efficiency.
- Assisted in the development of electronic approval forms using PowerApps to enhance workflow automation.
LMS Document Compliance Specialist
Glaxo Smith Kline (Contracted Through Valspec)
04.2018 - 02.2020
- Created and retired Read and Understand training items, 3-Tiered On-the-Job (OJT) training items, and curricula within SAP SuccessFactors/myLearning LMS.
- Updated training materials by modifying content and integrating new document versions.
- Managed job role assignments, adding and removing personnel as needed.
- Scheduled and recorded training sessions to ensure proper documentation.
- Generated Management Monitoring, Level 2, and Level 3 Audit reports for the BPDS group.
- Conducted daily CDMS (Document Management System) searches to ensure training documents, including SOPs, Work Instructions, Equipment Instructions, Analytical Methods, Guidelines, and Safety Risk Assessments, were available in myLearning.
- Set and managed release dates for documents requiring training in CDMS and myLearning.
- Performed quality checks on curricula and job role updates to ensure compliance.
- Provided user support and troubleshooting assistance for myLearning LMS.
- Managed and maintained the SharePoint site for myLearning requests.
- Designed and monitored the One Source Training Management SharePoint site.
- Proficient in SuccessFactors, myLearning, SharePoint, and Microsoft Office.
- Managed high-volume tasks with strong analytical and problem-solving skills.
- Contracted through Valspec
Compliance Scientist
Janssen Pharmaceuticals, J&J
06.2017 - 03.2018
- Company Overview: Contracted through Eurofins Lancaster Laboratories
- Ensured compliance with all relevant regulatory requirements (e.g., global cGMP) through ongoing monitoring and mitigation of any identified gaps.
- Redesigned training curriculums to align with the specific needs of individual job functions, ensuring they were 'fit for purpose.'
- Managed and updated the Compliance SharePoint site to enhance usability and accessibility.
- Produced weekly management reports detailing overdue training assignments and upcoming assignments within a 15-day window for the PDMS LM group.
- Supervised and supported a team of direct reports, providing guidance and leadership.
- Contracted through Eurofins Lancaster Laboratories
LMS Administrator/ Training Coordinator
Janssen Pharmaceuticals, J&J
10.2014 - 06.2017
- Company Overview: Contracted through VWR
- Completed formal training and qualification curricula on the Learning Management System (LMS) and governing documents (SOPs, Work Instructions, and Job Aids) for Stability Operations group at Janssen Pharmaceuticals.
- Managed training system access, created training curricula, and archived training records to ensure compliance with Global J&J Training standards.
- Created and updated user accounts, user groups, courses, training item codes, curricula, and quizzes in ComplianceWire- Learning Management System (LMS).
- Generated weekly management reports on training qualifications and assignments and provided quarterly Stability Management Review training metrics.
- Assisted and supported various audit inspections (FDA, EMA, etc.) concerning training and data handling procedures.
- Conducted laboratory logbook reviews to ensure adherence to cGMP standards and J&J local procedures.
- Contracted through VWR
Education
Bachelors of Science - Kinesiology
Temple University, College of Health Professions and Social Work
Philadelphia, PA12.2013
Skills
- Training & Development
- Learning Management Systems (LMS)
- Document Management Systems (DMS)
- Compliance Management
- Project Management
- Training Program Development
- SAP Successfactors LMS Proficiency
- Regulatory Documentation Management
- Cross-Functional Collaboration
- Microsoft Office
- Microsoft SharePoint
- Strong Relationship Management
- Strong Multi-Tasking Ability
- Detailed Oriented & Highly Organized
- Solution & Result Oriented
- Quick to Learn & Adapt to New Technologies
Languages
English
Native or Bilingual
Malayalam
Professional Working
Hindi
Elementary
Timeline
Precision Medicine Project Manager
Johnson & Johnson (Contracted Through LabConnect)
05.2025 - Current
Founder/ President
Independence Billboards
04.2023 - Current
Manager, Global Patient Safety Evaluation, Standards and Training
Takeda Pharmaceutical Company Limited (Contracted
12.2021 - 04.2022
Learning & Development Specialist
Merck & Co., Inc.
03.2020 - 11.2021
LMS Document Compliance Specialist
Glaxo Smith Kline (Contracted Through Valspec)
04.2018 - 02.2020
Compliance Scientist
Janssen Pharmaceuticals, J&J
06.2017 - 03.2018
LMS Administrator/ Training Coordinator
Janssen Pharmaceuticals, J&J
10.2014 - 06.2017
Bachelors of Science - Kinesiology
Temple University, College of Health Professions and Social Work
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