|Job Category :||Content Writing|
|Position Name:||Regulatory Technical Writer (100% REMOTE)|
|Location :||Parsippany, NJ 07054|
|Job Description :||Equivalent Experience Description: The Regulatory Technical Writer (RTW) plays an important role in the Regulatory Affairs Department supporting regulatory document writing to develop the global evidence base for company development programs. RTW is responsible for providing support to the Global Regulatory Affairs (GRA) team for all submission needs. The Writer in this position will develop documents required to facilitate global regulatory programs by incorporating an understanding of the clinical development program, relevant scientific literature, and regulatory goals to drive scope and direction of data-driven summaries. The Writer is also responsible for ensuring the accuracy and quality of submission-ready documents through close collaboration and review processes. The Writer partners with the project lead, other development working group (CDWG) contributing staff, as well as the Global Regulatory Lead/Area Regulatory Lead to prepare high-quality, accurate and concise documentation supporting the overall objectives. Responsibilities: Authors high quality regulatory documents including Clinical study reports, Investigator Brochures, Investigational New Drug (IND) submissions, Special submissions (e.g. ODD, PSP, etc.), meeting packages to agencies, responses to regulatory agency requests, clinical summaries, annual reports, and summaries contained in the modules of the Common Technical Document (CTD) in IND and all types of market applications (NDA, BLA, etc.). Provides support for the preparation and submission of critical regulatory documents and responses to health authority information requests using available reference materials, scientific literature, and content provided by Global Regulatory Affairs (GRA) team members. Prepare, write, edit, and review high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. When necessary, serve as the RTW role on project teams and functional area contributors to collaborate and advance the project. Participate in project management for compound programs and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Writer is to work closely with team members on the strategic content of target documents. Understand, assimilate, and interpret sources of information (eg, scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRA team and/or authors/key opinion leaders. Ensure required documentation is obtained. Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines. Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Assist in the arrangement and conduct of review meetings with the team. Resolve document content issues and questions arising during the writing process. Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs. Assist in the design and implementation of tactical process improvements. Qualifications: A Bachelor’s degree is required, either a Bachelor of Science, with significant relevant writing experience, or Bachelor of Arts in English or Communications with significant relevant science experience. A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred, and higher education may substitute for years of experience. American Medical Writing Association (AMWA) certification or other is a plus, with a specialty in Pharmaceutical Writing. Minimum of 2 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia, or in a related area such as quality, regulatory, clinical research, or product support/R&D. High-level content writing experience and experience with preclinical, clinical development and market application regulatory documents preferred, with working knowledge of statistical concepts and techniques. Knowledge of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations. Knowledge of Common Technical Document content templates, electronic document management systems and information technology. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following: Medical, dental & vision 401(k)/Roth Insurance (Basic/Supplemental Life & AD&D) Short and long-term disability Health & Dependent Care Spending Accounts (HSA & DCFSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.|
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