Medical Writer at Whippany

Job Description

• Ensuring the timely and correct creation of clinical study reports for Phase 1/2a studies as well as of project and submission documents in cooperation with the Clinical Sciences project leaders and study managers in accordance to the agreed submission relevant project-/study goals and abiding by all international and regulatory standards.
• Supporting CS Medical Writing Coordinators with medical and scientific questions relating to their assigned studies.
• Manages the planning, creation, review and approval of the clinical study report according the valid company SOPs in order to ensure the completion of high quality documents.
• Independently creates draft clinical study reports for Phase 1 and 2 a studies based on all available study documentation (e.g. statistical table sets, reference documents, subject data listings, etc.).
• Independently creates draft project or submission documents (or parts thereof) in close cooperation with the CS project responsible persons (Clinical Pharmacology Leader, CPL or Early Pharmacology Leader, ECL).
• Review of submission-relevant project and study documents for correctness, plausibility and compliance with company internal and international standards.
• Actively communicate and work with project or study teams as well as other key interface partners to facilitate the completion of clinical study reports and submission documents. 
• Support the Global Regulatory Strategist (GRS) and CPL in developing and maintaining all CS submission relevant documents for a particular project, work with the CPL to develop project level standards in line with overall messaging strategy, work with assigned submission team experts (Medical Expert [ME], CPL, GRS) in developing and implementing the submission authoring strategy for all CS sections needed for a submission.

Job Requirements

• Bachelor’s degree or higher degree in an area of natural science (e.g. medicine, pharmacy, biology) with at least 5-7 years of experience in the pharmaceutical industry in total, including a minimum of 3 years as a Medical Writer and demonstrates a working knowledge of medical and pharmacokinetic principles.
• The incumbent should have familiarity with clinical research, statistics, pharmacokinetics and regulatory guidances, standards and requirements pertaining to regulatory medical writing globally (e.g. ICH, FDA, EMEA).
• Experience should include working with complex documents, preferably pharmaceutical research and submission documents (e.g. clinical study protocols, clinical study reports, other submission documents.
• The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards (e.g. Documentum based systems, Adobe Acrobat, ISI-Toolbox). 
• The incumbent must be able to work on a wide variety of medical writing projects with minimal supervision. He/she must be highly organized and capable of setting up and maintaining the necessary procedures to ensure all projects are completed according to agreed timelines.
• The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
• The incumbent must be a skilled user of word processing applications (e.g. Microsoft Word and Excel).

Country: USA, State: New Jersey, City: Whippany, Company: Joule' Clinical.