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.

Clinical Pharmacologist working in the Pharma industry since 1989, in oncology, cardiovascular and respiratory therapeutic areas. An excellent communicator, writer and problem solver with broad experience in leading cross-functional project teams (preclinical pharmacology and pharmacokinetics, DMPK, safety, toxicology) for early compound selection and due-diligence activities, from IND through Phases I-III and BLA/NDA submission with regulatory agency experience. In-depth understanding of PKPD, pharmacometrics, population PK and translational medicine

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

Having helped launch Brilinta (ticagrelor tablets), Onglyza (saxagliptin), Farxiga (dapagliflozin), NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid / ezetimibe) and supported the post-launch activities of VASCEPA (icosapent ethyl) and Feraheme (ferumoxytol), I have become an accomplished Executive Medical Science Liaison and a tireless and passionate teammate, mentor, and leader in support of medical affairs activities.

I have covered multiple territories including the Atlantic States and Midwest (when I lived in Wilmington, DE), the Southwest and Northeast, Texas, and…

Marina Lewis, MD, PhD. Experienced Medical Director with a demonstrated history of working in the pharmaceuticals industry and Medical Device industry. Extensive experience in research in Academic setting. Experience in medical fields including Oncology, Hematology, Pulmonology, Pediatrics and Cardiovascular surgery. Twenty-plus years in research: Pathology, Microbiology, Histology, Cell Therapy, Immunotherapy, Molecular Biology and Immunology.Graduated from the Medical Academy of Sciences, Institute of Pediatrics, Moscow, Russia.

Twenty-four years of experience in the Pharmaceutical Industry mostly in Global Pharmacovigilance and Risk Management department. Very deep understanding of functions within Research & Development (such as Clinical Development, Regulatory Affairs, and Medical Affairs) and outside of R&D (QA, Supply Chain, and Commercial). Within Pharmacovigilance, expert in Clinical Trial and Postmarketing Safety; Aggregate reports; global Risk Management Plans; PV Operations; Outsourcing (medical information and pharmacovigilance); and Vendor management. Longstanding expertise in risk management issues associated with drugs…

My name is Paul Leverson. 

I am a practicing physical therapist with 27+ years of experience serving general outpatient orthopedic clients. In addition, I am certified in pain science through EIM since 2015.

My training in pain science allows me a particular perspective as to the biology of pain, neuroplasticity and neurosensitivity, specifically, actions and reactions.  This is valuable information to understand not only in the effective treatment of pain, but also in understanding how environmental stimuli   – from…

Physician-scientist with expertise in rare diseases and gene therapy and over 25years of leadership and management experience in academic, biotech and pharmaceutical industry settings.

•Led teams responsible for key aspects of the clinical development of 4marketed drugs:•Eliquis® (apixaban) Factor Xa inhibitor for thromboembolic disease

•Galafold™ (migalastat) chaperone for Fabry disease

•Tegsedi™(inotersen)antisense oligonucleotide for the polyneuropathic form of transthyretin amyloidosis

•Libmeldy™autologous hematopoietic stem cell (HSC)lentiviral gene therapy for metachromatic leukodystrophy(MLD)

•Expertise in clinical pharmacology, biomarker strategy, and clinical development of novel…

NA

Technical and operation oriented Regulatory professional with 21+ years of Regulatory Operations experience

Extensive experience in Regulatory Submission Management and strong background in eCTD and NeeS based submission formats

Well versed in Regulatory Systems/Applications selection and implementation process (Electronic Document Management Systems, Submission Document Authoring, eCTD Publishing, Submission Viewing and Submission Validation)

Experienced in building and re-organizing Regulatory Operation organization based on business needs

Experienced in aligning systems and processes between Regulatory and cross-function touch points (Adpromo, Quality, eTMF, PV…

Hi There, I am an Admin Expert.

Looking for a pharma R&D  SME to help us develop use cases, gain traction with early adopters and refine our offerings to be in further alignment with the life sciences R&D space.