Nevada Staffing
Senior Medical Writer - Structured Content Authoring - FSP
Nevada Staffing, Carson City, Nevada, United States, 89701
divh2Senior Medical Writer - Structured Content Authoring/h2pParexel is hiring an experienced Senior Medical Writer to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base growsmaking it a great learning experience and a chance to deliver impactful solutions./ppKey responsibilities include:/pulliConfigure and maintain SCA platform settings to support medical writing and regulatory workflows./liliCustomize templates, metadata fields, and document structures for compliance and efficiency./liliImplement and validate workflow configurations for review, approval, and version control./liliEnsure integration of SCA with other enterprise systems./liliConduct functional testing and troubleshoot configuration issues./liliMaintain detailed documentation of configuration changes for audit readiness./liliCollaborate with internal teams to gather requirements and translate them into technical solutions./liliProvide user training and support on SCA features and best practices./liliOffer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform./liliEnsure all configurations comply with regulatory standards and company SOPs./li/ulpRequired qualifications include:/pulliProven experience with SCA platforms./liliBackground in medical writing or strong familiarity with regulatory documentation processes./liliHands-on experience in content creation, review, standardization, and management within a structured content platform./liliDemonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents./liliFamiliarity with compliance and audit requirements in a GxP environment./liliStrong problem-solving skills and attention to detail./liliScientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar./liliFluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation./li/ulpPreferred qualifications include:/pulliExperience training users or driving adoption of structured content methods./liliHands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms./liliExperience working in a CRO or pharmaceutical environment./liliKnowledge of electronic submission standards (e.g., eCTD)./liliStrong communication skills for cross-functional collaboration./liliAbility to work independently and manage multiple priorities./li/ulpEducation: Bachelors degree in Life Sciences/Health Related Sciences or equivalent./ppWhy join Parexel?/pulliImpactful work: Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide./liliGlobal collaboration: Work with diverse teams across the globe in a dynamic, innovative environment./liliCareer growth: Access to professional development programs, mentorship, and opportunities for advancement./liliFlexibility: Enjoy the benefits of a fully remote role with a healthy work-life balance./liliInclusive culture: Be part of a company that values diversity, integrity, and collaboration./li/ulpReady to make an impact? If you are passionate about medical writing, regulatory excellence, and leveraging technology to drive innovation, we want to hear from you! Apply today and join Parexel in shaping the future of clinical research./p/div