Technical Writer - Regulatory
Company: Precision Biosciences
Posted on: November 11, 2018
Job Summary The Regulatory Technical Writer will be a key member of the Development organization and interface with Cell and Gene Therapy personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The technical writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. * Maintains consistent high quality and efficiency in the generation of technical documentation including clinical, nonclinical, and CMC to support regulatory filings * Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and orphan drug applications for cell and gene therapy programs * Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc. * Works with technical teams (CMC and nonclinical) to convert technical study data and results into reports in support of regulatory submissions, as needed, including training subject matter experts on technical writing skills and best practices * Supports generation of Common Technical Document-ready documents for regulatory publishing * Provides organization and finalization of all literature references to support submissions * Trains on Precision BioSciences document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed * Performs other activities as assigned * Reviews and edits documents as needed, including those authored by others both internally and externally * Participates in both internal and external project team meetings as needed and offers proactive solutions and advice to team members * Manages timelines and communicate with team members to maintain awareness of expectations, milestones, and document deliverables. * Coordinates and manages communications to enable timely reviews from authors and reviewers and to function as a collaborative team player * Ensures that documents undergo a quality check before approval Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. * Familiarity with the key requirements for regulatory submissions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics * Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred * Ability to critically analyze, synthesize, and present complex information in well-constructed documents * Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology * Ability to support multiple projects and to prioritize work independently * Ability to comply with company and/or industry style guides and templates * Ability to guide and train others in the writing of technical documentation * Fluent written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy * Advanced MS Skills in Word, Excel, and Adobe Pro Education/Experience: * Degree in Biological Sciences; BS or MS with 10 years experience or Ph.D. and 5 years experience in a technical writing capacity * Confidence to present to management, peers, and scientific or business collaborators * Strong written and verbal communication skills Work Environment * This position operates in a professional office environment, and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines * Travels when necessary to client sites or professional meetings * Typically works at a desk and computer in a climate-controlled office environment * Responsible for meeting tight deadlines * Participates in lengthy meetings with research groups, clients, and company management Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. * The employee must occasionally lift and/or move up to 25 pounds * Specific vision abilities required by this position include close vision, distance vision, and depth perception * While performing the duties of this position, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms, and talk or hear Travel Requirements * This position may require -10% travel on a periodic basis Precision BioSciences, Inc. is dedicated to improving life by developing advanced tools to edit DNA with a uniquely specific approach. Our proprietary method relies on a single small enzyme, ARC Nuclease, which combines cutting with sequence recognition and can be redesigned to find and edit new target sites across the genome. This simple, powerful gene editing solution allows us to create products that solve not just treat, but solve significant problems in oncology, genetic disease, agriculture, and beyond. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented, committed people who are excited to be a part of the medical and scientific breakthroughs enabled by Precisions next generation gene editing technology. For additional information, please visit www. precisionbiosciences.com Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.SDL2017
Keywords: Precision Biosciences, Durham , Technical Writer - Regulatory, IT / Software / Systems , Durham, North Carolina
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