Regulatory Writing Contractor

POSITION SUMMARY POSITION SUMMARY The Regulatory Writing Contractor is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work directly with client teams to manage regulatory writing projects. ESSENTIAL FUNCTIONS To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statements • Regulatory writing skills with mastery of 3 or more regulatory document types (e.g., clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components). • Solid understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area. • Manages at least 3 single-document projects simultaneously. • Working knowledge of: • Relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance • Core cross-functional clinical research roles and procedures, and how they relate to document preparation • Acts as a primary writer and/or project manager for key documents and projects. • Ensures document accuracy, completeness, and consistency of messaging. • Organizes and leads cross-functional document review meetings, clarifies and incorporates feedback, works with cross-functional subject matter experts to resolve unclear comments and differences of opinion between functional areas. • Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and writer peer review (logical flow, sense check etc.). • Leads project-level management activities, ie, timeline preparation and oversight and meeting scheduling. • Understands and complies with SOPs, templates, best practices, policies, and regulatory writing style guides. • Develops project-level lexicons and conventions. POSITION QUALIFICATIONS • Above average attention to detail, teamwork and initiative. • Ability to interact with clients and other departments within the company and be proficient in e-mail and verbal communication. • Proficient in Microsoft Excel, Power Point and Word and quickly able to learn new software. • Ability to apply regulatory guidelines to content development. Competency Statements • Ethical - Ability to conform to a set of values and accepted standards. • Accountability - Ability to accept responsibility and account for his/her actions. • Accuracy - Ability to perform work accurately and thoroughly. • Analytical Skills - Ability to use thinking and reasoning to solve a problem. • Detail-Oriented - Ability to pay attention to the minute details of a project or task. • Self -Motivated - Ability to be internally inspired to perform a task to the best of one’s ability using his or her own drive or initiative. • Organized - Possesses the trait of being well organized or following a systematic method of performing a task. • Tactful - Ability to show consideration for and maintain good relations with others. • Problem Solving - Ability to find a solution for or to deal proactively with work-related problems. • Project Management – Ability to develop and complete a project in a timely manner. • Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others. • Customer-Oriented - Ability to take care of client needs while following company procedures. • Communication, Written - Ability to communicate clearly and concisely in writing. • Communication, Oral - Ability to communicate effectively and professionally with others using the spoken word. Ability to present information to clients via videoconference or phone presentations. • Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience. • Working Under Pressure - Ability to complete assigned tasks under stressful situations. • Regulatory Understanding – Ability to apply regulatory and compliance guidelines to pharmaceutical industry. • Time Management - Uses time effectively and productively, prioritizes tasks, delivers results on time, solves problems quickly and decisively. • Work Ethic - Highly motivated, produces consistent high-quality work, has a desire to work hard, takes responsibility, learns from mistakes, follows through with commitments, is professional, is inclusive and welcoming, has respect for others, and goes above and beyond what is required. • Behavior and Attitude - Treats others with respect, projects and promotes a positive attitude, uses appropriate behavior, establishes good working relationships, resolves conflict effectively, and speaks kindly to others. • Self-Motivated - Ability to be internally inspired to perform a task to the best of one’s ability using his or her own drive or initiative. SKILLS AND ABILITIES Education: Advanced degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience. Experience: More than 2 years (typically >5 years) of experience in scientific/medical/regulatory writing in the pharmaceutical domain. Computer Skills: Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.