Get new jobs for this search by email

The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is an hybrid role typically requiring on-site presence at least 3 days per week.Responsibilities:Develop and execute strategies for organizing and preparing documents for regulatory health authority submissionsPlan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs)Oversee document preparation activities and track progress against targets; produce timely and accurate status update reportsProvide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing packageLead document review and comment resolution processes with cross-functional teamsLeverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reportsCoordinate the review and approval of documentsDevelop templates, style guidelines, and SOPs for regulatory documentationEnsure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirementsPreferred Education and Experience:JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD)Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiencesAble to compile, analyze, and present data clearly, concisely, and effectivelyExperience participating in submissions to the US FDA (IND, NDA) and EMA (MAA)Strong understanding of drug development and regulations (US, EU and ICH)Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirementsProficiency with Electronic Common Technical Document (eCTD) templatesStrong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queriesThe pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.Applicants must be currently authorized to work in the United States on a full-time basis.

#J-18808-Ljbffr