<p><strong>Medical Writer - Senior Regulatory Writing Specialist (Clinical) <br></strong><strong><br>Essentials:</strong><strong></strong></p> <ul><li>3+ years of regulatory writing experience (actual writing, not just a contributor)</li><li>Experience with at least 3 different regulatory documents (including but not limited to: clinical study reports, protocols, Investigators Brochures, briefing documents, Module 2 documents)</li><li>Client-facing experience/project management experience</li><li>Excellent attention to detail MS Word expertise</li><li>Experience with quality control (QC) review</li><li><strong>Fluent:</strong> C1 or C2 - English language</li><li>Clinical regulatory experience</li><li><strong>Location:</strong> Remote Brazil</li></ul> <p><strong>Nice-to-Have:</strong><br></p> <ul><li>PhD, PharmD, or MD</li><li>Nonclinical (or preclinical) writing experience (Module 2.4 or Module 4 documents)<br></li><li>Science or research experience (PhD/PharmD not required, but some scientific or research experience is helpful)</li><li>Experience with platforms such as Veeva Vault, Sharepoint, or PleaseReview Basic understanding of statistics</li></ul> <p><strong>POSITION SUMMARY</strong></p> <p>The <strong>Senior Regulatory Writing Specialist</strong> 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.</p> <p><strong>ESSENTIAL FUNCTIONS</strong></p> <p>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.</p> <p><strong>Essential Functions Statements</strong></p> <ul><li>Regulatory writing skills with mastery of 3 or more regulatory document types (eg, clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components).</li><li>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.</li><li>Working knowledge of: Relevant regulatory guidance (eg, 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.</li><li>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.</li><li>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.).</li><li>Leads project-level management activities, ie, timeline preparation and oversight and meeting scheduling. Participates in guiding less experienced writers on those documents for which they have expertise.</li><li>Proactively contributes to improvements to medical writing processes.</li><li>Understands, complies with, and contributes to the updates of SOPs, templates, best practices, policies, and regulatory writing style guides.</li><li>Develops project-level lexicons and conventions.</li></ul> <p><strong>POSITION QUALIFICATIONS</strong></p> <p>Above average attention to detail, teamwork and initiative. Ability to interact with other departments within the company and be proficient in written and verbal communication.</p> <p>Proficient in Microsoft Word, Excel, Power Point and Outlook, and quickly able to learn new software. Ability to apply regulatory guidelines to content development.</p> <p><strong>SKILLS AND ABILITIES</strong></p> <p><strong>Education: </strong>Advanced degree in a scientific discipline (eg, life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.</p> <p><strong>Experience: </strong>More than 2 years (typically 3-5 years) of experience in scientific/ medical/regulatory writing in the pharmaceutical domain.</p> <p><strong>Computer Skills: </strong>Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.</p> <p><strong>WORK ENVIRONMENT</strong></p> <p>Remote - Europe</p> <p><strong>Disclaimer</strong></p> <p>The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.<br></p> <p>By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. <a data-id="17431" data-type="page" href="https://medcommunications.com/privacy-policy/">Privacy Policy</a>. Please read this policy carefully for more information on your rights regarding personal data protection.</p> <p>We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.<br><br><strong>Recruitment Agency Notice:</strong><br><br>Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes.<br><br>Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.<br><br>Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.</p>