Director, Senior Account Executive And Regional Operation Officer Resume Example Buck Consultants A Xerox Company

DIRECTOR, SENIOR ACCOUNT EXECUTIVE AND REGIONAL OPERATION OFFICER

Professional Summary

Results-driven and high performing Senior Account Executive successful at cultivating new business relationships, up-selling to existing accounts and closing deals. More than 12 years of experience working in the medical and pharmaceutical industry holding positions in research and development, regulatory strategy, quality control, sales, marketing and business development.

Core Qualifications

Strategic

Operations management

Client-focused

Thinks outside of the box

Detail-oriented

Project management

Experience

Director, Senior Account Executive and Regional Operation Officer May 2012 to Current
Buck Consultants a Xerox Company － Secaucus, NJ

Manage a portfolio of key accounts, which generates over $6 million in revenue.
Surpass quota goals every year.
Lead the health care IBG.
Works closely with hospital administration in order to grow and develop the health care vertical.
Works closely with both pharmaceutical and medical device industry as part of the health care vertical. Integration, acquisitions and mergers.
Collaborates with other account managers and practice leaders to prepare and deliver performance updates and quarterly business reviews to executive staff.
Works closely with legal counsel to write and implement MSA's, SOW's and change order requests.
Determine the cost and pricing of proposals, bids and deal reviews.
Lead various Q-reviews and RFP's.
Plan, create and deliver strategic account plan presentations.
Negotiate details of contracts and payments and prepared sales contracts and order forms.
Deliver exceptional account service to strengthen customer loyalty.
Work closely with company executives to identify new business opportunities.
Account team operations management.
Implements key office initiatives.
Fosters a cross-office culture to ensure best solutions and resources are brought forth.
Coordinates activities with local CMs, AEs and new logo sales.
Contributes to the development of strategies to position Buck's brand for continued recognition and market share growth against competitor.
Supports market-specific marketing campaign, in partnership with marketing team and local Office Managers, promoting national events at the local level and coordinating local event opportunities.
Ensures participation at local industry events.

Senior Clinical and Regulatory Consultant May 2012 to Current
M2 － Remote, NJ

Perform all necessary tasks as required by the client for FDA IDE, 510k and De Novo submissions.
Attending consultant at various FDA and client meetings.
Research, compile and organize all necessary data to formulate effective regulatory and clinical strategies.
Define and manage study timelines and budgets.
Identification of potential qualified investigators and clinical sites, including initial contact with potential investigators, site assessments and initiations.
Advise and train study site personnel on sponsor and regulatory requirements for study conduct, adequate screening and enrollment of study subjects, data management expectations and adherence to study specific timelines.
Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
Responsible for the consistent planning, implementation and successful completion of clinical research activities for clinical trials.
Perform all necessary tasks as required by the client for Clinical Evaluation Reports CERs), Clinical Literature Reviews, and other regulatory submissions.

Clinical and Regulatory Director Apr 2009 to May 2012
E2/ElectroCore － Morris Plains, NJ

Planned budget and resources to start-up clinical trials.
Developed clinical and regulatory operational plans.
Managed clinical team in the protocol development process.
Designed and implemented study protocols working closely with physicians and KOL's.
Interfaced with relevant departments to facilitate operational activities including but not limited to: study specifications/scope of work/project timeline, vendor selection and contract execution.
Planned investigator meetings.
Managed development of study plans, i.e. Monitoring Plan/DMP/ SAP.
TMF management.
Ensured clinical trials were conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
Facilitated and actively participated in process improvement initiatives.
Ensured compliance to all manufacturing regulations and guidelines.
Managed CRO's and other applicable vendors.
Participated in conducting pre-clinical animal testing labs.
Collected and analyzed pre-clinical data.
Developed and maintained exceptional, steadfast relationships with medical staff.
Present in the operating room as applicable to capture data and answer questions about the device(s) and associated instrumentation.
Communicated with Investigative sites regarding study progress issues, communicate regularly with contacts within Joint Venture organizations, when appropriate, and communicate study progress/status on a regular basis to the executive board.
Advised and trained study site personnel on sponsor and regulatory requirements for study conduct, adequate screening and enrollment of study subjects, data management expectations and adherence to study specific timelines.

Sr. CRA, Study Manager Dec 2003 to Apr 2009
Stryker Spine － Summit / Remote, NJ

Lead CRA training and management of 6 CRA's across the country.
Lead in identification of potential qualified investigators and clinical sites as required, including initial contact with potential investigators and conducting pre-qualification visits.
Attended Investigator Meetings, Sponsor meetings as required.
Development of study specific project plans, monitoring tools, etc.
Liaison between the Project Manager and study site personnel to obtain and provide timely communication of site issues including enrollment status, protocol deviations/violations, SAEs, and other site issues.
Conducted Site Initiation Visits in accordance with the study specific Clinical Monitoring and Site Management Plan, including advising and training site personnel on Sponsor and regulatory requirements for study conduct.
Assisted site personnel with the development of recruitment strategies and enrollment plans.
Conducted Interim Monitoring Visits per the schedule defined in the study specific Clinical Monitoring and Site Management Plan to ensure compliance with the study protocol, GCP/ICH regulations, Sponsor SOPs and overall clinical objectives.
Reviewed site files and records, investigational product accountability records, case report forms and source documents for accuracy, completeness, consistency and compliance; identify deficiencies and discrepancies; provide additional training and initiate corrective action as required.
Conducted Close-out Visits per the study specific Clinical Monitoring and Site Management Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution and resolution of outstanding action items.
Prepared timely and accurate monitoring reports, confirmation letters and follow-up letters for all site visits as per the study specific Clinical Monitoring and Site Management Plan.

Education

Bachelor of Science 2003 Rutgers University

Biochemisty

C.R.A certified

Professional Affiliations

SoCRA

Rutgers alumni

NJ life sciences

RAPS

Accomplishments

Created strategies to develop and expand existing customer sales, which resulted in at least 5% growth YOY for all clients in my portfolio.
Managed a portfolio of key accounts exceeding $6 million in sales.
Ability and passionate about training and leading staff.
High performance scores leading to multiple promotions throughout career.
Most recently promoted to NJ office leader of business development, overseeing, managing and training in excess of 150 employees with the goal being to optimize our client relationships and growth targets.
Lead numerous industry expos where I was key note speaker.

Theraputic Expertise

Orthopedic * Degenerative Disc Disease (DDD) * Lumbar Fusion * Cervical Fusion * Osteomeylitis * Foot/Ankle Surgery * Endocrinology * Diabetes * Diabetic Foot Ulcers (DFU's) * Diabetic Neuropathy * Diabetic Retinopathy Gastroenterology * Obesity * Bariatric Surgery * Duodenal Switch * Balloon * Bypass * POI * Endoscopy * Endo Sleeve Respiratory * Asthma * COPD Oculoplasitc Surgery * Headache: Migraine/Chronic * Vagus Nerve

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Director, Senior Account Executive and Regional Operation Officer Resume Example

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