Experience

Culver Scientifics

Owner

Providing needs based consulting in the areas of scientific affairs, scientific and consumer based writing, regulatory affairs, scientific design, and both consumer and customer facing support (both consumer facing and customer facing). Recent projects include scientific dossiers collated for the purpose of ingredient structure/function claims substantiation and a customer facing
veterinary pharmaceutical excipient seminar.

OmniActive Health Technologies

Director of Scientific Affairs
  • Translate customer brief to market-friendly design for clinical studies to include white papers,
  • trade articles, podcasts, blogs, webinars, conference presentations, scientific events
  • Translate internal clinical science into relevant forms for regulators/customers
  • Scientific literature searches and internal reviews preparation for scientific/innovation/
  • marketing claim support/study design purposes
  • Present science for products to achieve appropriate product positioning with customers and
  • industry participants
  • Safety and regulatory dossiers for FDA-GRAS or NDI, Health Canada, and other regulatory
  • authorities in EU/Asia/South America to include responsible health claims, structure/function
  • claims, and appropriate product labels
  • Formulate and communicate the overall regulatory strategy effectively at all levels
  • Supervise commercialization of clinical studies with marketing and sales
  • Present scientific brief to customers to help commercialize the science behind their products
  • Attend industry functions and provide feedback and information on market and creative trends
  • Achieve clear understanding of product brief at scientific and business level
  • Updated as required with new relevant scientific information pertinent to the promotion of the
  • product portfolio
  • Facilitate the effective transfer of relevant scientific and clinical information required to meet the
  • needs and objectives of each business group
  • Manage ideation processes with customers; help present and drive concepts for innovation and
  • improvements

Abitec Corporation

Market Development Director, Pharmaceutical and Nutritional Health
  • Develop and design B2B communication including marketing materials, booth design, scientific
  • posters, handouts, and sales material (print and online)
  • Present new products and services and enhance existing relationship with current customers
  • Work with technical staff and other internal colleagues to meet customer needs
  • Attend industry functions, such as association events and conferences, and provide feedback and
  • information on market and creative trends
  • Present to and consult with senior level management on business trends with a view to
  • developing new services, products, and distribution channels
  • • Identify opportunities for campaigns, services, and distribution channels that will lead to an
  • increase in sales
  • Present business development training and mentoring to internal staff
  • Determine customers’ needs by obtaining market information
  • Recommend the nature and scope of present and future product lines
  • Assess market competition by comparing the company’s product to competitors’ products to
  • develop unique selling propositions and differentiators
  • Work with sales directors to develop product sales strategies
  • Assess product market data by calling on customers with field salespeople and evaluating sales
  • call results
  • Bring new products to market by analyzing proposed product requirements and establishing
  • time schedules with manufacturing
  • Introduce and market new products by developing time-integrated plans with sales, advertising,
  • and production
  • Determine product pricing by utilizing market research data; reviewing production and sales
  • costs; anticipating volume; costing special and customized orders
  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
  • Identify, research, and build relationships with potential clients; plan strategies based on client’s objectives and needs
  • Develop and implement go-to-market strategies including marketing strategies
Scientific Affairs Manager – Biosciences
  • Provide regulatory support for drug excipients (DMF), food, supplements, animal feed, and GRAS notifications
  • Make frequent presentations to all levels of customers including Physicians, Scientists, Formulators, and Sales and Marketing personnel
  • Work closely with the Regional Sales Managers in the field to optimize customer education and growth of sales
  • Present data at key scientific meetings/conferences regarding company’s products
  • Maintain a comprehensive understanding of scientific/clinical data and literature related to relevant company and competitor products and disease areas, and effectively transfers appropriate
  • Clinical/scientific information to key company personnel and external customers for business or educational purposes
  • Ensure all presentations are updated as required with new relevant scientific information pertinent to the promotion of our product portfolio and tailored to the specific audience
  • Work with Marketing to facilitate the effective transfer of relevant scientific and clinical information required to meet the needs and objectives of each group
  • Prepare executive summaries as necessary to address organizational goals and objectives
  • Lead research studies and acts as liaison with universities and technical consultants

The Hartz Mountain Corporation

Manager of Scientific and Medical Affairs

Regulatory Affairs Manager

As the sole veterinarian on staff, it was my responsibility provide guidance on all matters pertaining to an animal’s health and well-being. My largest contribution in this role was providing the scientific voice, perspective and accuracy for marketing and public outreach/media resources. This included writing for the end user (consumers) as well as for industry colleagues (veterinarians).

  • Responsible for the writing, editing and collecting of content to ensure a consistent voice across web material – this encompassed numerous web articles (>50), FAQs, answers to externally submitted questions, and technical bulletins targeted to both consumers and to veterinarians
  • Make frequent presentations to sales, marketing, and buying personnel
  • Present data at key scientific meetings/conferences regarding company’s products
  • Maintain a comprehensive understanding of scientific/clinical data and literature related to relevant company and competitor products and disease areas, and effectively transfers appropriate clinical and scientific information to company personnel and external customers for business and educational purposes
  • Work with Marketing to facilitate the effective transfer of relevant scientific and clinical information required to meet the needs and objectives
  • Developed and maintained contacts with key external opinion leaders regarding medical advances, collaborative studies and product related issues
  • Participated as internal consultant and ad-hoc member of project/product development teams in providing scientific/technical input
  • Assisted Marketing in the design, organization, execution of product to maximize product positioning and meet organization goals and objectives
  • Handled data analysis processes and distilled information obtained from collaborative studies/interactions for communications and recommendations to other departments
  • Prepare executive summaries as necessary to address organizational goals and objectives
Research & Development / Product Development

I had a leadership role on several Animal Health product development teams responsible for developing formulae to meet marketing needs and desired package claims while providing originality, scientific support, and evidence for an innovative product, all the while keeping within a specified cost of goods and providing real benefit to the owner and animal. Other obligations included:

  • Designing and writing test protocols and interpreting product-feeding trials (for acceptability, palatability, safety, etc.), nutrient analyses (for initial assessment and stability profiles
  • Determining statistical significance to package claims and for future direction of project development
  • Collating the data into easily readable charts for distribution to the product development team for comparing analysis results to formulation requirements, label guarantees, or to competitor’s formulae
  • Check raw ingredients for maturity or stability for processing and finished products for safety, quality, and nutritional value.
  • Confer with process engineers, plant operators, and packaging and marketing specialists to resolve problems in product development.
  • Develop new or improved ways of preserving, processing, packaging, storing, and delivering foods, using knowledge of chemistry, microbiology, and other sciences
  • Search for substitutes for harmful or undesirable additives
  • Stay up-to-date on new regulations and current events regarding food science by reviewing scientific literature
  • Study methods to improve aspects of foods, such as chemical composition, flavor, color, texture, nutritional value, and convenience
  • Study the structure and composition of food or the changes foods undergo in storage and processing
  • Test new products for flavor, texture, color, nutritional content, and adherence to government and industry standards
  • Develop new food items for production
  • Demonstrate products to clients
  • Participate in the development or implementation of clinical trial protocols
  • Recommends the nature and scope of present and future product lines by reviewing product specifications and requirements; appraising new product ideas and/or product or packaging changes
  • Assesses market competition by comparing company’s product to competitors’ products
  • Introduces and markets new products by developing time-integrated plans with sales, advertising, and production
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
  • Contributes to team effort by accomplishing related results as needed
Regulatory Affairs Manager

My grounding in R&D had provided a stable and knowledgeable support base for the Nutrition Regulatory Affairs division. I was responsible for two direct reports in this capacity and managed a budget of almost $800,000. My responsibilities included:

  • Formulating and implementing regulatory affairs policies and procedures to ensure that compliance is maintained or enhanced
  • Maintaining current knowledge of relevant regulations, including proposed and final rules
  • Monitoring emerging trends regarding industry regulations to determine potential impacts on business units
  • Supervising documentation efforts to ensure compliance with domestic and international regulations and standards
  • Providing responses to regulatory agencies regarding product information or issues – in this instance the Association of Feed Control Officials (AAFCO), National Animal Supplement Council (NASC), and the Center of Veterinary Medicine (FDA CVM)
  • Reviewing all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
  • Directing the preparation and submission of regulatory agency applications, reports, or correspondence
  • Establishing regulatory priorities or budgets and allocate resources and workloads
  • Providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
  • Reviewing materials such as marketing literature including product labeling and advertising to ensure that regulatory agency requirements are met
  • Training staff in regulatory policies or procedures
  • Investigating product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
  • Coordinating internal discoveries and depositions with legal department staff
Consumer Affairs and Public Relations

I had a strong public relations component this position. This included being “the face of Hartz” in print ads, on web sites, in television commercials, radio spots, and at trade shows. Other duties included:

  • Acting as a liaison to veterinary professionals and journalist (magazine and newspaper) interviews
  • Responding to product inquiries both consumer and more intricate veterinary issues through the “Ask Dr. Melinda” function on the website
  • Interfacing with the Consumer Affairs department to review call center cases that would have been sent to an outside agency for review and recommendation

Southway Animal Clinic

Associate Veterinarian
  • A large portion of my work as a small animal practitioner was comprised of diagnosis of disease processes, selection of medical treatments and medications, proper patient selection for medical treatments, routine physical exams and vaccinations, writing health certificates, running and interpreting lab work (CBC, blood chemistry profiles, specialty endocrine assays, fecal and urinalyses) and radiographs to aid in disease diagnoses, and monitoring of ICU patients 24 hrs
  • My surgery skills involve proper aseptic technique and tissue handling, proper plane of anesthesia, and the ability to apply known surgery techniques to new situations. Surgeries I have performed range from simple abscess and laceration repairs to gastrotomy/enterotomies, eneucleations, and femoral head and neck osteotomies
  • Emergency work (estimated 700 hours per year) often consisted of fielding emergency after-hours calls from all clinics in the area, assessing patient viability with a phone consult, patient triage and stabilization. Patient care continued until case resolution. Emergency calls were performed with minimal to no tech support
  • Other duties: maintained patient records, returned client phone calls, and performed callbacks on complicated medical and surgical cases

Washington State University

Instructor

  • Companion Animal Diseases, Washington State University (new class). I developed a syllabus, website, more than 40 PowerPoint/visually engaging lectures, 3 exams and a final for this class. The scope of the class included common diseases of companion animals, basic animal physiology and genetics as well as some of the more common disease processes and outcomes in cats, dogs, ferrets, and horses. The class was well received and grew from 26 students in spring 2005 to more than 45 students in its terminal semester. Spring 2005, Fall 2005, Spring 2006
  • Physiology of Animals, Teaching Assistant, Washington State University. I assisted in animal labs involving sheep that were used to demonstrate animal physiology on the live (anesthetized) animal. Additional duties included answering student questions and grading quizzes. Fall 2000