Hiring: Associate Director, Medical Writing Company: Supernus Pharmaceuticals, Inc. Location: Rockville, MD Job Posted Time: 2026-09-10 12:01:57 Target Skills & Keywords : Microsoft Office, Project Management About the job Experience: •5+ years relevant work experience in pharmaceutical companies or CROs. Required Skills: •Provides strategic input into program-level plans for document development and authoring, deliverable level timelines to meet program-level goals and objectives. •Provides leadership and guidance at the team level as an SME for document scope and content. •Contributes strategically and scientifically at the study team level with recommendations for data reviews, collection of specific data, data outputs, and document content. •Proactively advice study and submission teams regarding regulatory requirements and ICH guidance for clinical documents. •Aligns, coordinates, and builds consistent information and messages across clinical program(s) for deliverables. •Documents for NDA, BLA, IND, CTA, SOPs, etc •Reviews and provides oversight of documents prepared by outside contractors for content, clarity, accuracy, consistency, and alignment with company’s position. •Proactively anticipates risks, provides solutions, and takes necessary actions to mitigate risks, manages expectations of stakeholders. Qualifications: •Bachelor’s in physical or life science required with a minimum of 8+ years of experience or a Master’s degree with a minimum 6+ years of relevant medical writing and project management experience. •PhD degree is highly desirable with a minimum of 5+ years relevant work experience in pharmaceutical companies or CROs. •Demonstrated direct clinical regulatory writing experience in a pharmaceutical, biotech, or CRO space. •Demonstrated experience in being able to lead, collaborate, and manage people. •In-depth knowledge of Microsoft Office. •Solid functional working knowledge of medical terminology. •Operational familiarity with relevant regulatory guidance especially ICH E6 and E3. •Demonstrated capacity to work independently and as part of a team and maintain high ethical standards of integrity and quality. •Ability of having an innovative and dynamic approach to work. •A self-starter able to work independently but comfortable working in a team environment. Compensation: •$166,000 - $193,000 / year •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!