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Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA

Experienced Master’s level accountant, financial analysis and contract/project management professional.

Highly focused and diligent accountant with an excellent employment record of accuracy and client satisfaction. Exceptionally discreet and ethical financial manager across a variety of businesses. Able to work well independently or as part of a financial management team.

Ideal Companies: SAS, Blue Cross Blue Shield NC, State Employees Credit Union

Tags for this Online Resume: Management, Data Management, SAP, Audit, Billing, Services, Commissions, Financial, Manufacturing, Oracle, Contract Management, Order Manager, Bookkeeping, A/P, A/R, analysis, salesForce, DocuSign

Clinical Research Project Manager Interested in Growing with a Patient Centered Organization

​My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...

Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.

Clinical Research - 2 Years of Experience - Near 90057

QUALIFICATIONS SUMMARY Years as a CRA (total number): 20 Therapeutic Area (s): Oncology, Ophthalmology, Cardiovascular, HIV/HCV, Asthma, CNS, Infectious Disease, Pain Management, Gastrointestinal, Osteoarthritis, and Diabetes Years of Oncology Experience (as a CRA): 20 Indications (within Oncology only): Breast, Colon, Rectal, Prostate, Ovarian, Bladder, Pancreatic, Lung, Head and Neck, Cervical, Renal, CML, ALL Phases (wit...

Tags for this Online Resume: Clinical Research, Research, Management, Project Management, Policies and Procedures, Forecasting, HIV, Oncology, Quality, Quality Assurance

Pharmaceutical/Biotech Account Management - 15 Years of Experience - Near 33763

CAREER SUMMARY Proficiency to Protocol Implementation Adherence to Regulatory FDA Requirements Creative Research Strategies Study Participants Critical Care Registered Respiratory Therapist (RRT) 14 years Pharmaceutical Hospital Sales Experience KEY ACHIEVEMENTS: * #1 Enrollment manager in nation with PAREXEL * 5th in Sales in Nation by January 2009 after successful launch of new biotech medication in July 2008 with Adolor ...

Ideal Companies: Pharmaceutical/Biotech Account Management Sales

Tags for this Online Resume: NICU, Transportation, Pharmaceutical, Sales, Sales Executive, Trauma, Critical Care - Respiratory, Intubations, Protocol, ACLS, oncology, clinical, phase, trial, gcp, protocol, sas, pharmaceutical, Registered Respiratory Therapist, Arterial line insertions, Drawing gases, interpretation of gases and vent changes, PowerPoint, Word, Excel, budgets, speaking engagements, presentations from 20 to 300, territory analysis every 30 days

Dedicated healthcare professional

Dedicated healthcare professional with 14 years of clinical, administrative and management experience, including 6 years as a Clinical Research Coordinator and 14 years as a Medical Assistant. Combined clinical skills and business acumen. Excellent communication and interpersonal skills. Master of Science in Clinical Research Administration degree.

Ideal Companies: Clinical Research

Tags for this Online Resume: Recruiting, Microsoft office, Liaison, Employee Development, Clinical Research Coordinator, Medical Records, Healthcare Administration, Management, Data Collection, Analysis, Medical Terminology

Clinical Research

I am currently exploring new opportunities where I can utilize my more than 20 years of experience to add value to the clinical research industry. My experience includes 8.5 years as a Clinical Trial Assistant, 4 years as an In-House CRA, 1.5 years as a Regional CRA, and 5 years supporting study start-up and site activation. I enjoyed managing regional clinical sites the most and want to further my career and skills in this...

Tags for this Online Resume: Protocol, Management, Documentation, Data Entry, Clinical Research, Compliance, Document Review, Research, Query resolution, Inform Consent Form, eCRF guidelines, SAE Reporting, AE Reporting, IRB Submissions, Regulatory Compliance, ICH / GCP / FDA guidelines, Database lock timelines met, Site deficiencies resloved, Patient enrollment and retention, Ongoing site education and support, Ensure lines of communication remain open, Study specific SOPs, Electronic Data Capture, InForm, Phase Forward, Medidata, BioClinica, Oracle, Siebel, Share Vault, Phlex Global, PhlexEview, Egnyte, Trial Interactive, Microsoft Word, Excel, Publisher, PowerPoint, DocuSign