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Technical Writer

Company name
alpha consulting corp.

Hopewell, NJ

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Job Description
TECHNICAL WRITERHOPEWELL, NJ Project Description: The primary role is to support the regulatory activities for clinical submissions (IND/CTA) for biologic products as part of the CMC Strategies team. The CMC group is committed to supporting the biologics network with integrity, reliability, active engagement, and cross-functional collaboration.\tSupport the process for regulatory submissions while interfacing across the Client network.\tAssist in the facilitation of authoring, review, verification, and submission-ready compliance for the finalization of filings.\tPreparation of CMC elements of regulatory filings\tParticipation on various cross-functional project teams, interactions with technical teams and global regulatory-CMC staff at different Client sites and other key partners both internal and external to the company are necessary.\tMust possess the ability to support multiple projects and to prioritize work independently.\tWork in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.\tDemonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines. Required Skills:\tBS degree or MS degree in scientific field with 0-5 years of pharmaceutical experience. Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems.\tMust demonstrate an understanding of the global CMC regulatory guidelines, practices and applications.\tProven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication.\tMust have a working knowledge of regulatory submissions for clinical submissions (IND/CTA).\tAbility to successfully collaborate with a diverse group of technical professionals and interpersonal styles is required.\tMust be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process.\tPossess strong interpersonal skills and demonstrates ability to effectively interact with business functions. This 6 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Ashley: ALPHA'S REQUIREMENT #18-00214MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Company info

alpha consulting corp.
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Company Profile
Our goal, in addition to communicating the benefits of becoming associated with Alpha Consulting, is to provide news, opinions, and resources to assist Clients and Consultants. As with our careers, the content will continuously change and evolve over time. Alpha Consulting Corporation is an IT (Information Technology) staffing firm with the ability to understand your specific project requirements and promptly supply appropriately matched consultants to fill both short and long-term client needs. Solely Focused on IT Staffing Unlike many firms, we do not allow ourselves to become distracted through the pursuit of permanent placement. We do, however, accommodate specific client requests for assistance in identifying qualified permanent employees or negotiating the mutually agreeable conversion of a consultant to a client's permanent staff. We also do not engage in software development, outsourcing, or offshore activities. Our effectiveness is maintained by specializing on our core competency, IT staffing, to the benefit of our clients and consultants. As a small, privately held firm, free from quarterly Wall Street pressure, we have the ability to stay focused on the individual needs of our clients and consultants. Operating from a single location further enables us to concentrate our efforts and provide superior service and support.

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