A strategic thinker with extensive hands-on experience (15+ years) developing new medicines for rare diseases or areas with high unmet medical needs. Highly regarded as a dedicated, passionate and innovative Regulatory Affairs Leader throughout career. Contributed to successes of a number of development organizations.

 Led and/or contributed to global licensing of 9+ products and development of 21+ products o Solid US, EU and global RA (GRA) working experience managing full-spectrum product development, marketing applications (NDAs/BLAs/MAAs: NMEs, 505(b)(2), hybrid), approvals…

Strategy, Intelligence and Product Development: • Member of core/executive drug development teams and/or Program Team Lead • Created and managed multiple global strategies for drugs, biologics, biosimulars and combination products • Conducted regulatory research and intelligence on a global basis for various therapeutic indications/areas • Performed gap analyses to identify potential challenges to successful IND, NDA, MAA, BLA and NDI/DS filings

Scientific Advice Meetings: • Wrote, managed and compiled associated packages for FDA/EU/EMA/Health Canada scientific advice meetings • Conducted in-person…

1200 word content write up of 2023 Decentralized Clinical Trials predictions.  Primary input- interview of thought leader, plus individual DCT trends research.  To be published in pharmaceutical trade journal.

Clinical research professional with 20+yrs academic and biotech/pharmaceutical industry experience. M.D. Ph.D. pulmonologist with expertise in (rare) respiratory, auto-immune, inflammatory and fibrotic diseases. Physician-scientist bridging basic and clinical science, thrilled to guide new discoveries through clinical development.

Highly accomplished leader of pharmaceutical industry with wide range of experience in project and organizational leadership. 20+ years of international drug development expertise coupled with strategic, operational and management experience.

◄ Core competencies include ► ★ In-depth Biopharmaceutical Industry Experience ★ Extensive Drug Development/Life Cycle Management ★ Product Development Plan Creation & Prioritization ★ Hands on Project & Program Leadership ★ US, EU, & International Experience ★ Strategic Alliance Experience

◄ Key Accomplishments ► ★ Developed asset for Phase…

I love everything about Clinical Research. Most of all, I am passionate about getting Clinical Research Sites that are struggling or research naive back on track and audit ready. I went from doing lab work at the bench to researching the effects of the drugs made at the bench in people. If you are looking for a passionate, enthusiastic and high-performing Clinical Operations Consultant and Clinical Research Associate, look no further. I specialize in Site Management and Monitoring, Study Start-up,…

Technical and Scientific Nonclinical Writing, Team Lead, Director

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global…

As a Professional Nonclinical & Toxicology Consultant and Diplomate of the American Board of Toxicology, I provide professional strategic IND-enabling and NDA-program planning and execution for drug development with focus on small molecules and peptides for Oncology in solid and hematologic cancers, neurodegeneration, osteoarthritis, IPF (idiopathic pulmonary fibrosis), obesity, dermal (AGA, atopic dermatitis, psoriasis and tendinopathy) and multiple other indications. Regulatory writing for IND/NDA nonclinical documents as subject matter expert (SME), review of Pharmacology/PK/Tox reports, IND timeline management, Integrated Risk…

Preclinical Safety Assessment Scientist and Project Manager with 30+ years of Medical University and Global Pharmaceutical industry experience. Specializing in Toxicology and Core Safety Pharmacology studies, Pharmacodynamics/Pharmacokinetics/Metabolism, IND-enabling Services, Proof of Concept and Candidate Selection, Strategic Program Management, Investigative and Regulatory Cardiovascular and Renal Safety Pharmacology, CRO Selection, Audit and Monitoring, Preclinical Safety Assessment, Market Analysis, Business Opportunity Assessment and Safety Pharmacology Training Workshops. Expert in strategic planning of preclinical drug development programs, protocol design to provide…

Hello,

I am Jessica Green. Owner of Crystalline Pharmacare, LLC. I am just starting my journey of independent consulting. I have 5 years experience in Safety and 10 years experience in TMF. In Safety I was a case processor and then moved on to write narratives. During my time in Safety I found my love of improving processes. In TMF, I started as a TMF Lead, managing projects and TMF Health. I spent my last 5 years creating and implementing…

Assistant professor with multiple patients well versed in tech transfer and business management and pre-IND drug discovery/development.  Phenotype Evangelist,

help for bookkeeping and quickbooks

General Manager and Visionary Pace-Setter with progressive experience delivering incredible growth results for companies ranging from entrepreneurial start-ups to global Fortune 500 enterprises. Careerlong record of success launching new products, crafting compelling brand stories, building best-inclass business development functions, innovating new marketing and sales vehicles, and facilitating multimillion-dollar M&A transitions and exits. Incredibly diverse career includes both senior marketing and sales experience at life sciences, technology, financial services, luxury, and major media companies.

§  A team player with ability to perform a deep literature search and understand complex scientific topics, enthusiastic collaborator experienced in setting strategies, meeting deadlines and milestones to reach ambitious goals as evidenced by successful completion and delivery of NIH, DOD and VA funded projects and multiple collaborative projects.

§  Expertise in writing manuscripts, study reports, IACUC and IRB protocols and driving the document review process from start to…

Life sciences professional with an entrepreneurial mindset and experience in supporting scientific and business needs. Experience in managing preclinical and clinical drug development programs. Demonstrated strength in proactively identifying business opportunities and facilitating strategic partnerships and collaborations with stakeholders in the industry, academia, and government. Adept at implementing business strategies, conducting due diligence, and developing solutions to resolve challenges. Passionate about working at the intersection of science and business to improve patient outcomes.

A small, Arizona based sponsor currently in Phase II with a leading candidate in oncology, among others, looking to explore with FDA their Phase II as a transformational trial, protocol amendment/s, etc. as they move towards study start up.

A proven operational leader who offers a record of success in introducing strategies that drive growth, define short-and  long-term  strategic  vision,  and  create  a  positive  company image.  Builds productive internal and external relationships to advance corporate revenue  achievements,  while delivering significant time  and cost savings. Hires, trains, mentors, and leads teams across multiple disciplines.

Medical editing and content management system experience