Senior Medical Writer
Location
United States
Posted
5 days ago
Salary
$116K - $128K / year
Seniority
Senior
No structured requirement data.
Job Description
Senior Medical Writer
Veristat
Role Description The Senior Medical Writer - Safety Focus is a major contributor to document authorship for a variety of aggregate safety reports within the safety service line. The Medical Writer - Safety Focus will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Qualifications - Bachelor’s degree or higher, in a scientific discipline strongly preferred - 2 to 5+ years of regulatory writing experience with aggregate safety report writing including: - Development safety update reports (DSURs) - Periodic safety update reports (PSURs) - Periodic benefit-risk evaluations reports (PBRERs) - Risk management plans (RMPs) - Periodic adverse drug experience reports (PADERs) - Addenda to clinical overviews (ACOs) - Safety topic reviews - Understand regulatory authority guidelines and requirements to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance - Experience in the development of aggregate safety reports Requirements - Proficiency with Microsoft Word skills (editing tools, creating, and modifying tables, and inserting figures) and document management techniques - Strong understanding of the document creation process and of the drug development lifecycle - Ability to work in a collaborative environment, be tolerant of differences in culture and beliefs, easily build relationships with others, openly share information, and willingly contribute toward accomplishment of team goals - Be action- and detail-oriented, always seeking new development opportunities to build knowledge and skills - Show flexibility to meet project needs as required by deadlines and to meet corporate goals and objectives - Remain knowledgeable of changes in the industry and adapt best practices - Demonstrate solid time management and other organizational skills - Ability to synthesize data across multiple data sources and documents to create summary reports - Ability to use logical arguments to persuade others when presenting ideas and suggestions but also respond positively to opposing views voiced by others - Develop professional relationships with clients to further the business relationship and maintain current industry knowledge - Ability to identify and institutionalize work practices that are most effective to ensure consistency in performance Benefits - Remote working - Flexible time off - Paid holidays - Medical insurance - Tuition reimbursement - Retirement plans
Related Guides
Related Categories
Related Job Pages
More Content Writer Jobs
Autor, Lektorat/Korrektorat, Fortbildungsinhalte, Pflegekinderhilfe / Vollzeitpflege
DiinguB2B e-learning platform for the social sector – flexible, pedagogical, AI-powered.
• Unterstütze uns bei der Ausweitung unseres Fortbildungsangebots auf den Bereich Pflegekinderhilfe / Vollzeitpflege (§ 33 SGB VIII). • Du wirkst an der gemeinsamen Erarbeitung und Weiterentwicklung eines Curriculums bzw. einer Themenstruktur für den Bereich Pflegekinderhilfe / Vollzeitpflege mit. • Du recherchierst umfassend aktuelle Fachliteratur sowie evidenzbasierte Methoden und Best Practices. • Du entwickelst fachspezifische Lerninhalte für Fachkräfte der Pflegekinderhilfe auf Grundlage bestehender Konzepte oder gemeinsam erarbeiteter Strukturen. • Du überarbeitest bestehende Texte sprachlich und fachlich. • Du sorgst für eine präzise und verständliche Aufbereitung der Inhalte und stellst sicher, dass die Texte sprachlich einwandfrei und fachlich korrekt sind. • Du trägst aktiv zur strategischen Weiterentwicklung unserer Fortbildungskurse bei, indem du branchenspezifische Trends und Best Practices identifizierst und in die Kurse integrierst.
• Creating formal written quotes and proposals based on client specifications and knowledge of laboratory services. • Ensuring that the lab has the appropriate certifications and can meet any technical specifications. • Collaborating efforts and activities with those of outside sales account managers and technical staff, as needed. • Transition project wins from Business Development to Project Management. • Additional job duties as assigned.
• Ability to contribute reliably and consistently (buying guides, tutorials, and news) under tight deadlines. • Willing to input work into our in-house CMS, as well as find and format images, according to our guidelines. • Stay up to date on the latest computing news, products, and hardware updates. • Coordinate with the editorial team for assignments and feedback.
• Drive Proposal Success • Collaborate with proposal managers and sales leaders to develop persuasive, differentiated proposal content that wins business. • Conduct thorough market and therapeutic area research to ensure proposals are informed, relevant, and compelling. • Contribute strategic insights to planning meetings—identifying client needs, recommending study approaches, and ensuring feasible, high-quality solutions. • Own the proposal development process from strategy through delivery, managing timelines and ensuring all stakeholders are aligned. • Master Contract Development • Partner with contract specialists to develop clear, compelling contract language that protects Parexel while meeting client expectations. • Navigate complex contractual requirements and MSAs with confidence. • Identify potential issues early and work collaboratively to resolve them before signature. • Build Organizational Excellence • Maintain and enhance our proposal and contract templates, ensuring they're current and accessible. • Contribute to case studies and thought leadership materials. • Share lessons learned with the team to continuously improve our processes. • Mentor and support junior team members as you grow into a leadership role.
