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Job Details

Strategic Feas Writer

Company name
Pharmaceutical Product Development, LLC.

Location
Wilmington, NC

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Summarized Purpose: Sources and analyzes data from investigator surveys, literature searches, and internal and external databases to clearly and concisely incorporate into surveys, Requests for Proposal, bid defense presentations and feasibility reports. Essential Functions and Other Job Information: Essential Functions\u00a0 Prepares deliverables, including critical evaluation of data and creation and modification of tables, figures, text and\/or slides for presentation of data. Drafts and reviews feasibility surveys. Supports preaward efforts (strategies for RFP, RFI and bid defenses) through research, data analysis and writing proposal text. Assists with ad hoc requests for departmental initiatives, including gathering updates and reporting performance metrics. Participates in internal and external training as appropriate regarding feasibility assessment and clinical trial methodology. Manages the timelines of the feasibility report draft and review process, coordinating input from the within and outside of the department (i.e., medical, regulatory, and project management staff). Qualifications Education and Experience: Bachelor's degree or equivalent and relevant formal academic \/ vocational qualification. Advanced degree (PharmD, PhD, MD) preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years\u2019). Prior experience in clinical trial feasibility surveys or analysis preferred. Knowledge, Skills and Abilities: Good and effective time management skills Capable of multitasking and effectively interacting with cross functional teams, including senior level staff, to influence adherence to feasibility reporting timelines and associated client deliverable requirements Basic working knowledge of biomedical and clinical trial concepts Good grammatical, editorial, and proofreading skills Good problem solving, organizational, and data mining\/research skills Good ability to interpret and present extremely complex data in preparing a coherent written document Proficient with Microsoft Word and other applicable software packages Good prioritization and time management skills, flexibility to adapt to changes in work duties, responsibilities, and requirements Capable of working independently with limited supervision Good analytical and critical thinking skills Working Conditions and Environment: Work is performed in an office\/ laboratory and\/or a clinical environment Exposure to biological fluids with potential exposure to infectious organisms Exposure to electrical office equipment Long, varied hours frequently required Travel required on rare occasions Physical Requirements: Ability to work in an upright and \/or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and\/or local law. Organization -Site and Patient Access Primary Location -North America-United States-North Carolina-Wilmington - Home Based

Company info

Pharmaceutical Product Development, LLC.
Website : http://www.ppdi.com/

Company Profile
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 12,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

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