• Responsible for researching, writing, and editing materials for regulatory submission to the FDA from pre-clinical to clinical trials Phase 1 - 4 • Works collaboratively with Clinical Project Managers, Clinical Trial Associates (CTA) and other cross-functional departments • Identifies and executes timeline plans for clinical, nonclinical, and CMC • Coordinates, authors, and develops drug applications and submissions in support of clinical programs • Offers high visibility and exposure to FDA regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, and/or eCTD format • Author and compile FDA and Ex-US regulatory applications and submissions • Assist in the research of scientific and regulatory information to write submission documents • Work with data management and clinical teams to review protocol development and interpret clinical trial data • Responsible for contributing to project timelines and regulatory milestones • Responsible for communication of commitments to team members • Lead multiple, concurrent projects, with support from the Principal or Regulatory Manager • Format and edit regulatory documentation for inclusion in INDs, CTAs, and other global submissions • Support on-time preparation and publication of regulatory submission documents

Role Description JoVE is seeking an experienced Peer Review Editor to coordinate our peer review process from submission to editorial decision. You will manage reviewers, oversee review quality and timelines, and ensure that manuscripts meet JoVE’s scientific rigor, ethics, and reporting standards, delivering a clear, timely, and positive experience for authors and reviewers alike. - Manage end-to-end peer review for assigned submissions (reviewer selection/invitations, review monitoring, decision preparation, and revision management). - Build, vet, and maintain a high-quality reviewer pool; track expertise coverage; build network with top reviewers for rapid, fair evaluations. - Monitor timelines and throughput (e.g., time to first decision, reviewer acceptance/turnaround); proactively unblock delays and optimize workflow. - Collaborate with JoVE Editorial and Production teams to deliver a smooth author journey from submission through publication. - Identify and implement process improvements (templates, automation, dashboards) to reduce cycle times and improve review quality. - Maintain accurate records in the manuscript system (e.g., Editorial Manager, Monday.com): reviewer activity, decisions, correspondence, and policy exceptions. Qualifications - A Bachelor’s degree in the life sciences or a related field (advanced degree a plus). - 5+ years in scholarly publishing with hands-on peer review experience. - Working knowledge of peer review models (single-blind, double-blind, open), open access workflows, and emerging trends in scholarly communication. - Proficiency with manuscript systems and workflow tools (Editorial Manager strongly preferred; comfort with automation/AI-assisted tools for efficiency). - Exceptional written communication and editorial judgment; able to synthesize complex feedback into clear, actionable decisions. - Strong organization and project management skills; thrives in a fast-paced, deadline-driven environment. Benefits - A competitive compensation package. - You will make a direct impact in accelerating science research and in improving student learning in science education. - Opportunity to work with global teams and in an environment that promotes innovation and collaboration. - Our strong promotion from within culture draws a clear path to advance your career with us.

• Subject-matter and didactic review of geography content: You review exercises and learning texts for factual accuracy and didactic quality and provide targeted corrections and improvement suggestions. • Quality assurance of content: You review prepared materials directly in the authoring document or via the live preview and propose adjustments. • Subject-matter support for the editorial team: As a subject-matter expert you advise our editorial team on content-related questions and help to represent topics accurately and in line with curricula.

Role Description This position is available for remote work. The Proposal Writer is a critical role responsible for ensuring the successful and timely delivery of high quality, commercially competitive proposals, which are fully aligned with the company’s revenue and profitability goals, enabling the increase in conversion rate from proposal to signed contract, and ultimately increased market share for Sharp Clinical Services. The Proposal Writer will work closely with the Business Development (BD) teams in the preparation of proposals for new and ongoing business, interpreting client requirements for commercial projects, clinical study protocols or synopsis to draft proposals by working with the internal and external stakeholders. - Manage the complete RFP proposal process and timelines to exceed customer expectations and facilitate efficient, high quality and timely delivery of proposals that are fully aligned with Sharp’s commercial and financial objectives. - Complete full project assessment, evaluating scope, objectives and client requirements to enable proposal generation. This may include determining alternative strategies for the client to consider. - Manage and lead operational feasibility calls/discussions as required. - Liaise with clients/BD regarding information for proposals as and when required in addition to any other internal/external stakeholder to enable proposal generation. - Where applicable, design a packaging strategy and investigate packaging options to provide best solutions for our customers. - Calculate the unit costs for all aspects of proposal requirement using Sharp’s costing model and suppliers/service providers cost matrix or ad hoc cost estimates obtained as applicable. - Formally write up the proposal and manage the proposal approval process in accordance with Global Pricing Policy. - Fully support the global pricing team to ensure all team goals and objectives are met. - Completion of internal systems and trackers as appropriate. - Maintain compliance with Sharp’s Standard Operating Procedures (SOP). - Maintain compliance with all applicable departmental spreadsheets, filing and administration processes. Qualifications - Bachelor’s Degree or equivalent work experience. - 5 - 7 years prior costing and proposal experience, preferably in a pharmaceutical company or related vendor environment. - Strong understanding of cost structures, pricing strategies and profitability analysis. - Experience managing timelines and deliverables across different departments. - Knowledge of drug development stages (preclinical, clinical, commercial). - Must have strong writing, grammar and proofreading skills. - General understanding of cGMP guidelines is preferred. - Familiarity with CDMO contract structure (Fee-for-service, Milestone-Based, FTE-Based Pricing) is strongly preferred. - Familiarity with GMP (Good Manufacturing Practices) and regulatory requirements (FDA, EMA, MHRA) strongly preferred.