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Georgetown, SC

Georgetown, SC

Georgetown, SC

Georgetown, SC

Georgetown, SC

Medical Director
Eagan, MN

Director Regulatory Affairs
Eagan, MN

Miami, FL

Our Clients
Choose Category: 
 File No.  1B6F4C
 Location  San Francisco
 Designation/Title  Pharmaceutical Sales Representative
  • Managed a client portfolio consisting of over 150 physicians in efforts to promote three cardiovascular lipid lowering products (Trilipix, Niaspan, Simcor)
  • Collaborated with four team members strategically targeting high volume cholesterol primary care physicians in the San Francisco territory
  • Successfully launched Trilipix, a fibrate for dyslipidemia, targeting key physicians and achieved 80% penetration of top decile prescribers   
  • Total performance to date is 97.3% of sales goal, exceeding both nation and region; Trilipix  and Niaspan  performance above both nation and region
  • Winner of Spiff and “Reward It” bonuses for achieving sales goals

 File No.  B848CA
 Designation/Title  Regulatory Affairs Specialist

Highly experienced Regulatory Affairs Specialist with a 6 year record of providing results for employers and clients.  I have a RAC certification from the Regulatory Affairs Professional Society demonstrating my expertise.  The services I can render include:

  • Knowledge and competence in regulations and good practices governing clinical trials and new pharmaceutical products
  • Assemble, organize and submit applications to the FDA for new drug products
  • Advise clients regarding regulations and standards for clinical trials
  • Reputation for honesty, reliability, and fostering good relationships

 File No.  C78318
 Location  Manassas
 Designation/Title  Director of R&D
  • Ten years of experience in early and late stages of therapeutics development
  • Strong knowledge in multiple therapeutic areas including metabolic diseases, oncology and infectious diseases
  • Excellent business management and leadership skills
  • Managed teams including internal direct reports, external consultants, contract labs and academic collaborators
  • Led complex projects from start-up, implementation and completion within timeline and budget
  • Presented and chaired at international scientific meetings
  • Excellent communication skills in both English and Mandarin

 File No.  8BE777
 Location  Vernon Hills
 Designation/Title  Scientific Manager
  • Specialized in discovery and clinical research /development of novel cancer therapeutics.
  • Strong expertise in translational medicine bridging discovery and developments of therapeutics, and managed the interface between research and clinical development.
  • Over 10 years of post-doctoral managing and recruiting experience to build and expand research teams with hiring Ph.D., M.D., M.S. and B.S. levels of scientists and lab managers.
  • Highly skilled at applying immunology, cell biology, microbiology and molecular biology background in discovery, development and clinical analysis of cancer therapeutics.
  • Established and managed research activities in tumor immunology and discovery of biomarkers, which were translated into pre-clinical validation and clinical development.
  • Skilled at epitope prediction for development of new cancer therapeutics and experienced in identification of potential cancer targets.
  • Provided scientific leadership in research and clinical development of therapeutics.
  • Coordinated clinical trials support activities for early therapeutics development (Phase I/II).
  • Well versed in developing immunotherapeutics in oncology/hematology, establishing clinical monitoring strategies, supporting late stage (Phase III) of clinical development, measuring disease-specific immune responses in patients and directing bioassay development activities.
  • Skilled at design and validation of biomarkers, immuno-stimulatory antibodies and immunogenicity studies, and implementation of them in clinical analysis.
  • Experienced working with regulatory agencies and in identification and management of contract research organization (CRO) alliances.
  • Accomplished close collaborations formed through networks to industry and academic entities to implement new initiatives based on a comprehensive background in science.
  • Experienced in strategic plans and implementation of biotechnology initiatives to a start-up company, and managed scientific and technological evaluation of in-licensing opportunities.
  • Facilitated cross-functional activities (research, development, clinical, finance, legal, commercial) and operational planning, delivered project goals, led due diligence, managed team operations, and communicated updates to upper management team.
  • Identified and evaluated new cutting-edge technologies, skilled at strategy development and integration of development plans, and demonstrated international experiences.
  • Led multidisciplinary teams, acted as primary contact to extramural partners, accommodated issue resolution, and assured correct and timely information flow to stakeholders.
  • Directed and oversaw experiments following Standard Operating Procedures (SOP) and using Good Laboratory Practice under Biosafety Level 2 and Level 3 conditions.

 File No.  63C4FB
 Location  Philadelphia
 Designation/Title  Sr. Medical/Technical Writer, Clinical Affairs
  • Worked on the European Medical Device Directive as it applies to Clinical data and reports
  • Conducted literature reviews to determine the most recent, relevant clinical data regarding advice or device family
  • Reviewed existing technical files and identify areas that do not meet the most recent standard
  • Updated and developed Device Technical files to meet the most recent standard specifically the European Medical Device Regulations
  • Authored clinical reports and documents used in regulatory submissions.
  • Assured timely accurate and complete collection of data from the literature searches and or study data
  • Interacted with various customers (internal and external) in order to facilitate and complete regulatory submissions
  • Handled multiple projects
  • Performed other related duties as assigned

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