Business Development Manager

Roseann Affinito

**** ********** ******

P.O. Box 1518

Toms River, New Jersey 08755

Mobile : 973-***-****

Email : ************@*****.***

POSITION: Business Development Manager

Life Sciences - Pharmaceutical, Biotech, Medical Devices, Clinical

Personal Summary

Dynamic, self-motivated Life Sciences /Pharmaceutical /Medical Device / Clinical/ Environmental Sales/Marketing and Global Account Business Development Professional with a 15 + year record of achievement and demonstrated technical sales success and negotiations of contracts in Drug Development: Preclinical, Phase I, II, III and post marketing for Rx, Generics, OTC, Cosmetics and Consumer Products filing FDA IND through NDA applications. Experience also includes sales of environmental lab testing services abiding EPA regulations to include: Soil, Water, and Air. Deep knowledge of both industry regulatory agencies and their guidelines. Cross-selling all laboratory testing services (Pharmaceuticals, Environmental, Food, Water, Health, Veterinary, and Cosmetics).

Established long-term relationships in EAST COAST and MID-ATLANTIC regions in both industries. Exceptional account base to drive sales growth and market share in highly competitive markets. Exceptional communication and organization skills, regulatory, clinical, and R & D project management skills with diverse science and business background. Secured customer loyalty and established strong relationships with executive level customers R & D, Clinical, IT, Legal, Regulatory, and Procurement through strategic global planning and research. Major accounts include top 100 pharmaceutical companies and previous accounts include large environmental firms.

Researched, organized face-to-face, web meetings, and presented laboratory testing services and quality system to prospective clients. Meetings included department executive levels only.

Past Marketing Chair for the Association of Clinical Research Professional - Metro New York Chapter with an established network of pharmaceutical, biotech, and investigator relationships.

Life Cycle Management skills from selection of API, preclinical, moving through Phase I, (" a quick to clinic" approach), Phase II, Phase III, Post Marketing to include: Reformulation of existing drug. Projects include: Various dosage forms for Rx, OTC – Switch: Orals, Solids, Softgel and other innovative technologies. Sales of CRO lab testing services for genomics, discovery pharmacology (toxicology), PK Bioanalysis, forensics, and for supporting global clinical trials.

Working together with our Operations team, provided testing and solutions to customers filing FDA IND/NDA or Medical Device (510K) applications. In addition, our ISO Certified laboratories provided support for testing, recalls, auditing, thereby meeting all regulatory requirements for safety and quality (ISO 9001 Quality Management System) for continual improvement of processes, products, and services. Laboratories provided regulatory and compliance support.

Environmental Accounts includes the top 25 Environmental companies in tri-state area working with Government, State, Municipalities, and private sector. Projects included testing: water, soil, air, and innovative new technologies. Deep knowledge of EPA guidelines and chemical testing.

Professional Experience:

i-Start-Me-Up, LLC. January 2016 – Present

Independent Sales and Marketing Consultant: Laboratories, Medical Practices, Hospitals, Pharmaceutical Companies:

Assisting Start-Up Life Science / Healthcare companies: Contract work for Pharmaceutical, Consumer, Biotech and Medical Device start-up companies to include all customer service, CRM, administrative, sales, and creative marketing

Develop sales and marketing plans to include EDC programs, SWOT analysis, and other sales and marketing functions for large Medical Practices.

CRM implementation – Program: Salesforce, Hubspot

Data input and Management Reporting: Sales, Marketing, Social Media

Existing Database of pharmaceutical, medical device, biotech and environmental accounts in tri-state area

Ocean County Vocational Technical School: September 2021 – Present

Substitute Teacher for Medical Assistant Certification and Medical Terminology Classes

Impact Analytical Laboratory – Now Element Laboratory October 2020 – February 2023

Sales and Marketing Consultant – Contract under i-Start-Me-Up, LLC.

Laboratory Sales to include:

Laboratory Testing Services for: Pharmaceutical and Medical Devices

Consumer Products, AgroSciences, and Specialty Chemicals.

Marketing Services: Assisting and attended industry trade shows, sorted leads,

Technical Materials: Researched and created preliminary white papers, brochures and other marketing materials. CRM system is Hubspot. Uploaded created templates into CRM system

Alternative Biomedical Solutions: November 2019 – May 2020 (Contract)

Regional Account Manager – Laboratory Sales to include:

LC/MS Service and maintenance contracts for SCIEX

Refurbished laboratory equipment (LC/MS)

Sold Laboratory consumables, parts, training and support

Introduced established R & D laboratory accounts to ABS

Microbac Laboratories, Inc. December 2017 – June 2019

cGMP / GLP Technical Sales Manager:

Review project detail with prospective clients to include Rx, OTC, Generics, Cosmetic companies.

Responsible for gathering and organizing resources for major key accounts

Work closely with the lab technical team to review the RFP and align projects with Operations,

Establish CDA’s and review technical RFP’s

Organized and gathered resources for key accounts

Laboratory testing services for various projects include Microbiology, Chemistry, and Virology testing.

CRM System is: Salesforce

Intertek Pharmaceutical Group: CRO (Contract) February – June 2016

Business Development Manager – Life Sciences for GMP Laboratory

Developed new accounts and increased sales for CRO services to include my existing pharmaceutical / biotech account base. Maximized existing accounts 30% and goal of 70% for new business.

Trained in GMP.

Gene Dx: Division of Bioreference Labs and OPKO Pharmaceutical: (Contract)

Medical Appeals Investigator for Customer Service

Start up division for Bioreference Labs / Optko Health (Gene Dx) (April 2015 - October 2015)

Position entailed the review of patient’s medical records which have been denied for payment and obtaining additional appropriate clinical records to support the denial of the appeal. It is necessary to build a case for the insurance company (based on medical need) as genetic testing is still not recognized as a medical necessity. Worked closely with patients, physician offices, Genetic Counselors and major hospitals nationwide.

Princeton Consumer Research: Princeton, New Jersey / UK (Consulting)

Sales Consultant (July 2014 - March 2015) - Contract Position

Start-up: Developed marketing and sales plan for US Start-Up company

Established new pharmaceutical relationships for UK - US subsidiary to promote laboratory testing services (Pharmaceutical and large consumer companies)

Immediate results of new accounts / sales to include major pharmaceutical and consumer companies

Worked closely with clinical groups of OTC cosmetics and other products to develop plans for clinical testing services at the laboratory

Major Pharmaceutical / Biotech Corporate Accounts Manager -

STS CORPORATION - Global Distributor of Active Pharmaceutical Ingredients (API)

September 2013 - July 2014)

Generated new drug product development opportunities from API to drug Phase I-III

Increased alternate source opportunities for commercial product

Maximized growth opportunities / revenue with existing customers working with customers existing pipeline and various therapeutic areas

Managed sales through forecasting, negotiations and closing the sale

Communicated information regarding new drug development projects with global team

Arranged meetings at major industry event (cPHI) to discuss customers upcoming drug development programs and inventory needs for commercial manufacturing of API

Director,Business Development - USA Accounts (GLP Laboratory) GLP Lab

KCAS BIOANALYTICAL LABS: (CRO) (August 2012 - September 2013)

Sales of laboratory testing services. Strategized CRO outsourcing programs for analytical and biopharmaceutical laboratory testing services to pharmaceutical ( Rx, OTC, Ophthalmic) and biotech companies including Phase I, II or Phase III of drug development programs

Delivered immediate new business results / accounts and RFP’s with high revenue possibilities and results

Understands the internal politics of pharmaceutical and biotech to penetrate accounts and work with stakeholders within accounts.

Sales of Biologic Services – Clinical trial support

Completed global RFI’s for corporation and clinical sites – review protocol

Works closely and cross-functionally with internal groups to move project: Operations, Legal, Finance, Marketing and Sales TEAM

Business Development Manager - USA and Global Accounts (GMP Laboratory) GMP Lab

FRONTAGE LABS: (CRO) CMC – Clinical – Bio – DMPK (August 2010 – August 2012)

Introduced strategic CRO outsourcing programs for analytical and biopharmaceutical laboratory testing services to pharmaceutical ( Rx, OTC, Ophthalmic) and biotech companies including Phase I, II or Phase III of drug development programs

Delivered immediate new business results / accounts and RFP’s with high revenue possibilities and results

Completed global RFI’s for corporation and clinical sites – review protocol for China and USA Projects

Obtained CDA’s and negotiated MSA’s from major pharmaceutical accounts to align major pharma global procurement global offices for Frontage corporate brand awareness and centralized purchasing power

Negotiated successful Master Business Agreements with major pharmaceutical

Developed long term business relationships with key executive contacts at the top 20 pharmaceutical companies – currently have a solid base of global accounts

Presented to major pharmaceutical and biotech R & D / Purchasing / Regulatory groups reviewing all laboratories capabilities

Reviewed incoming projects with operations team

Organized client meetings with Operations team to acquaint themselves with new incoming large pharma accounts (to accustom customer to internal operations team)

Business Development Manager – Mid-Atlantic Region (GMP Laboratory)

SGS LIFE SCIENCES (CRO) R & D /QC Laboratories Division (January 2008 – July 2010)

Strategic planning, budgeting and sales of clinical research organization (CRO) laboratory testing services (R & D, Quality Control services, GMP, GLP) to global pharmaceutical, medical device, major consumer product and cosmetic companies within the Mid-Atlantic Region.

Planned visits and provided weekly technical presentations to pharmaceutical executives and their clinical teams; introduced SGS’ European clinical research organization (CRO) capabilities in an effort to increase sales and corporate brand recognition.

Increased sales by 20% in specific Mid-Atlantic states.

Representing (3) SGS laboratories within North America; worked with clients to scope projects for their Phase I – IV clinical trials adhering to ICH and other regulatory guidelines.

Reviewed legalities of contracts and finalized RFP pricing for large proposals prior to submission to client.

Worked cross-functionally with the laboratory staff and other departments to close the sale and win the projects while maintaining detail and clear communication among everyone on the team.

Developed strategic bio-pharmaceutical market plan for prospective business in the Mid-Atlantic States and presented to European corporate office. Plan successfully used by SGS clinical sales team.

Maximized existing accounts and provided resolutions to client issues relating to laboratory testing services

Attended conferences and exhibitions pertaining to industry; follow up on leads and close sale

CRO: Business Development Manager, Trained at Corporate office in Germany

ACCOVION INC. (August 2006 – December 2007) – Clinical Trials

Basic clinical trials training with CRO company located in Germany. Phase I, II, III and Post Marketing Adverse Event Reporting. Trained with various departments including Pharmacovigilance, Biostatistics, Regulatory and Quality Assurance in an effort to learn the drug development process involved in clinical trials – Phase I – IV, post marketing. Sales office located in Admour, PA.

Developed new business opportunities with pharmaceutical companies working in Phase I, II, III and post marketing projects. CITI training: New York Presbyterian Hospital (see attached certs)

System: Siebel and worked with eClinical platform

Pharmaceutical Sales Representative – Customer Service Division: Corp / Field Sales

DAIICHI PHARMACEUTICAL CORPORATION, Montvale, New Jersey (April 2001– March 2006)

Business Planning:

Responsible for the sales and promotion of anti-infectives and Internal Medicine Specialties to approximately 400 remote Pediatricians and Rheumatologists

Exceeded market share higher than the national average brand consistently

Achieved average 125 - 150% of sales goals for 2004 and 2005

Territory accounted for 75% of the internal customer sales department

Increased market share of approximately 350 field zero-market share specialty physicians located throughout the U.S. achieving 25% total growth in 2006

Collaborated with cross-functional teams in Marketing / Distribution / Logistics effectively distributing regulated samples utilizing a sample-by-mail program abiding PDMA / FDA guidelines

Member of Sales Advisory Board: Preview new clinical & marketing material before distribution

Pilot group for Siebel System: Roll out to field reps and customer service teams. Trained Inventiv reps

Customer Service Division:

Respond to all incoming inquiries regarding product indications, federal supply schedules, patient assistance program, managed care, adverse event reporting and other client and physician related issues

Government Sales: Hospitals and Clinics

Developed and executed a sales plan for Government Public Health services including Native American Health Hospitals and Clinics

Increased Government sales by 35% in Public Health Services

Successfully developed and established business relationships with key decision makers in the DOD, Navy, BOP, Coast Guard and other Public Health Sectors

Organized and attended industry trade shows, conventions and meetings

Successfully achieved two major regional government formulary wins encompassing over 150 hospitals and clinics resulting in increased government sales in Native American Public Health

Contributed articles to industry magazines in an effort to gain recognition

Familiar with DOD procurement process and contract bidding

Computer Software Training:

Proficient in MS Word, Power Point and Excel; excellent presentation skills

Experienced in management reporting for: IMS, Siebel, SAP, Oracle, ACT, Access, Sales Logix and Salesforce, and HRIS

Sales Training and Support:

Mentor for Corporate Sales Training Program for Ventiv Health contracted rep

Pilot group for Siebel System (internal customer service and field reps)

Selected by executive staff for the Sales Advisory Board

Developed two Customer Service Sales Training Manuals

Trained and worked in conjunction with field reps in achieving Public Health Service Hospital Formularies throughout mid-west states

Extensive ongoing Corporate Sales Training Programs including POA’s

Trained in FDA, PDMA, ICH, NDA and Corporate SOP compliance programs

Trained in GCP, GLP and GMP practices

Advanced educational workshops in physiology, biology and basic drug development

Hands-on training in the laboratory and trained in clinical trials phases, I, II and III

Selected as representative for Department’s SFA (sales force automation) pilot study team

Accounts Sales Manager - Major Accounts (1996 – 2000)

Integrated Analytical Laboratories

*Environmental Laboratory Network, Inc.

Sales of analytical laboratory testing services: water, soil and air to environmental engineering firms

Sales and promotion of laboratory services to major environmental firms and pharmaceutical Industry

Sales of analytical laboratory testing services to Government DOD

Established approx. (200) new business accounts

Increased sales from $1.5 to $4.0

Introduced packaged pricing increasing existing customer base sales (RCRA metals)

Maximized existing accounts increasing sales by 25%

Introduced innovative service line for laboratory analysis (Phytoremediation).

Member of the U.S. Interstate Innovative Technology Committee: Wash, D.C

Eventually evolved into well-water testing business for private sector and municipalities. I started my *own company and left Integrated Labs

Project Management:

Priced and managed laboratory bids, contracts, and reports (municipal and government work)

Priced requests for proposals (RFP’s) and finalized contracts with client

Collaborated with various departments to complete project by contract date.

Sales Operations Manager: (1992 – 1995)

Sentex Sytems, Holmdel, NJ

Managed U.S. Subsidiary reporting directly to VP Sales in Japan

Sales Planning: Established US five-year Sales and Marketing plans

Established international sales targets and sales goals analyzing market information, the competition, primary/secondary data and generating quarterly/yearly management reports aligning to Japan’s Corporate office ten-year plan

Arrange International meeting to include actual and forecasted budgets for sales team

Sales Assistant: (1989 – 1991) (Full-Time)

BECTON DICKINSON CORPORATION, Franklin Lakes, New Jersey

Liaison to field reps and corporate office – bids, proposals, client relations

Human Resources Assistant – Promoted to Sales Assistant (1988 – 1989)

BECTON DICKINSON CORPORATION, Franklin Lakes, New Jersey (Part-Time)

Assisted Manager and Director of Human Resources in all H.R. functions

Achievements

Merit Scholarship - Oxford University, England, (short-term study abroad program) International Business; Deans List

National Business Honor Society; Inducted Beta Xi, Alpha Beta Gamma,

American Management Association, Inc., New York, (Program: Operation Enterprise) -Scholarship - Selected for a three-week intensive entrepreneurial business training program held in Lake Placid, NY

Merit Scholarship: Ho-Ho-Kus College - NJ – Computer Science (1 year Certificate program)

Awarded numerous sales performance awards and bonus’

Caldwell College 2014 - Inducted into the National Society of Leadership an Success, Sigma Alpha Pi (Academic Accomplishment and Leadership in Business)

Education / Certifications

Columbia Southern University – Bachelor’s degree (final year)

New Jersey Certification # as a Substitute Teacher

Rockland Community College, New York, International Marketing (Transferred Credits)

CRA: University of Michigan – (Nursing Program) online certificate program

Certified as (CRA – Clinical Research Associate) - Complete understanding of Clinical Trials from Phase I through Phase III, including FDA approvals and post marketing manufacturing

Languages

Bilingual: Fluent in English / Italian

Volunteer Work

ACRP: Past Marketing Chairperson – Metro New York Association of Clinical Research Professionals

Cross Cultural Volunteer Program

National Society of Leadership and Success, Sigma Alpha Pi - Leadership Honor Society

Previous Member of the Chamber of Commerce

Yearly Drive: "One Warm Coat" for children and adults

New York Presbyterian Hospital

Hospital: Volunteer at Pediatric Clinical Unit (while training as a Clinical Research Associate)

*CLINICAL RESEARCH ASSOCIATE (CRA) Certification – January 2011

University of Michigan – Department of Nursing

*CITI TRAINING /CERTIFIED – January 2011

Affiliation: New York Presbyterian Hospital – Weill Cornell Medical (Special Studies)

Basic institutional Review Board (IRB) regulations and review process, Genetic Research in Human Populations, Research w/ culturally / medically vulnerable groups, history and ethical principles, informed consent, international research, records-based research, research and HIPAA privacy protections, research with protected populations, social and behavioral research for biomedical researchers.

1)*INTERNSHIP: Clinical Trials Assistant / Patient Recruitment – P/T

New York Presbyterian Hospital – Div. of Pediatric Special Studies

New York (January 2010 – March 2010)

2)*INTERNSHIP: Clinical Trials Assistant - P/T

Fieve Clinical Research – New York City (Dr. Fieve – Author)

New York (October 2010 – March 2011)

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