Divya Jaswal
74 Waterman Drive, Clyde,VIC
Summary
PMI certified project management professional with overall 9+ years of experience in healthcare, pharmaceutical companies. Able to oversee multiple projects simultaneously while ensuring that corporate resources relating to contract negotiating and managing, budgeting, purchasing, scheduling, cost control and accounting are properly administered. Strong analytical, problem solving & organizational abilities complemented by core values of integrity, compassion, performance excellence and team work.
Overview
11
11
years of professional experience
Work History
Project Manager
Jubilant Biosys
12.2020 - 04.2023
- Coordinate Project initiation activity, kick off meeting & scheduling of project telecommunications, once a project is confirmed from Business team.
- Supervised a cross-functional team to deliver synthetic, medicinal chemistry projects within budget
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Project timeline tracking for timely deliverables & timely raising to senior team mates for issues/concerns
- Cross departmental functioning for project work across different R&D sites
- Effective communication in discussion with technical team & senior team mates with external and internal stake holders SCM, logistics, technical, QC, IPR, BD) for project needs.
- Documenting relevant points with client & internal stakeholders for process adherence & audit record keeping.
Sr. Executive-Business Development and Project
Synchron Research Services
04.2019 - 12.2020
- Develop, coordinate and implement marketing plans to maintain and increase existing business, capture new opportunities & establishing initial business communication
- Hosting visits and meetings, develop presentation, support new clients with regard to CRO services (Conducting feasibility check)
- Preparation of site agreements, MSA, Contracts, Agreements and CDAs, budget and financial/site payment tracking during study conduct
- From product feasibility analysis, managing execution of pilot and pivotal bioequivalence studies, interpreting pharmacokinetic & statistical bioequivalence results to clinical study report submission
- Overseeing project operations and functions such as planning, design and development of project protocols, regulatory submission, data acquisition and management, analysis and reporting of study results, management of supplies and resources in adherence with the project timelines, budgets and quality standards.
Subject Matter Expert (Regulatory Solutions)
Sarjen Systems, Therapeutics
05.2017 - 03.2019
- Requirement gathering from clients.
- Involved in strategic planning for the future scope of progress and development in the field of pharmacovigilance.
- Keeping up breast of Regulatory guidelines (such as ICH E2B (R3), GDPR) know-how and its applicability in pharmacovigilance solution.
- Giving value-addition training to new and existing clients for enhancements/upgrades/Change Requests.
- Product implementation & ongoing support.
- Assisting team in interpretation and correct application of norms.
- Validation of specific documentation such as IQ, OQ and PQ for regulatory solutions.
- Participated and Documented internal/External audits and other quality assurance activities.
- Support operations in providing root cause, CAPA closures and change control process.
- Ensured consistent adherence to quality and compliance procedures, meeting internal and external requirements.
- Developed and executed corrective action plans as needed, mentoring employees to properly execute such plans.
Clinical Research Associate & Trainer
ClinSoft Clinical Research
10.2015 - 05.2017
- Maintaining Communication with sponsors and internal departments & submission to Ethics committee for approval of the protocols, ICF and its updates, other study related documents, Study Updates.
- Preparation, compilation and reviewing of Case Report Form, TMF and Source document verification, check in, Dosing and check out procedures.
- Prepare, maintain and updating all the systems and SOPs in the department.
- Conducting and compiling training evaluations and producing monthly training reports.
- Provide Training to study personnel on GCP, SOP, Protocol, CRF and Study related activities.
Medical Research Associate
ADI BackOffice Professionals
07.2012 - 01.2015
- Managing the Clinical Data process for multiple simple or complex trials
- Acquisition of data from internet, Case Report Forms (CRFs) & Data Clarification Forms (DCFs)
- Collect & analyze the information about marketed & development stage products of Pharmaceutical companies
- Handle analytic queries of client related to clinical trials
- Construct records for clinical trials conducted all over the world
- Cover a wide variety of public & proprietary data bases: FDA, EMEA, NCI, CTRI, UMIN, PubMed for trial related information
- Data Analysis, Data Mining & Secondary Research
- Competitive scientific meetings and literature (PubMed) coverage
- Worked in Oncology, Cardiology, CNS team
Education
Project Management Professional(PMP) -
Project Management Institute
Melbourne, VIC07.2023
Master of Business Administration -
Panjab University
India2018
Post Graduate Diploma - Pharmacovigilance
Cliniminds
India2014
Bachelor of Pharmacy -
Chandigarh College of Pharmacy
India2012
Skills
- PMP Certified Professional
- GCP Certified Clinical Trainer
- MS Excel, MS Word, PowerPoint
- Project Scope Analysis
- Bioavailability/Bioequivalence Studies
- Regulatory Compliance
Achievements
- Awarded with “Best Client Service” of the year by Sarjen Systems
- Got first prize in Presentation Competition held in ADI backoffice professionals
- Selected for EMG (Event Management Group) for conducting Events in Office
- SILVER MEDALIST: Got this Award from President of India, Dr. A.P.J ABDUL KALAM for securing 7th rank (Merit position) in Punjab Technical University.
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Punjabi
Native or Bilingual
Gujarati
Full Professional
Timeline
Project Manager
Jubilant Biosys
12.2020 - 04.2023
Sr. Executive-Business Development and Project
Synchron Research Services
04.2019 - 12.2020
Subject Matter Expert (Regulatory Solutions)
Sarjen Systems, Therapeutics
05.2017 - 03.2019
Clinical Research Associate & Trainer
ClinSoft Clinical Research
10.2015 - 05.2017
Medical Research Associate
ADI BackOffice Professionals
07.2012 - 01.2015
Project Management Professional(PMP) -
Project Management Institute
Master of Business Administration -
Panjab University
Post Graduate Diploma - Pharmacovigilance
Cliniminds
Bachelor of Pharmacy -
Chandigarh College of Pharmacy
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