Medical writer

• Research, write, edit, reference, and annotate scientific and medical materials, including manuscripts, abstracts, posters, congress materials, slide presentations, advisory board materials, newsletters, eLearning modules, digital content, medical/commercial communications, and materials for lay audiences
• Conduct literature reviews, analyze data, and prepare materials for MLR review and defense
• Ensure scientific accuracy, readability, stylistic consistency, and alignment with AMA style, journal/congress requirements, client standards, and regulatory expectations
• Contribute to scientific narratives, communication platforms, and strategic content initiatives
• Manage content development from initiation through delivery, ensuring high-quality, timely outputs and proper version control
• Serve as the scientific lead in client meetings, advisory boards, workshops, and planning discussions
• Provide scientific expertise and strategic recommendations that support client and brand objectives
• Support business development through scientific insights and pitch materials
• Participate in publication planning and scientific communications activities
• Recommend authors, journals, and congresses using evidence-based rationale
• Apply knowledge of publication planning processes, timelines, and best practices
• Mentor junior writers through editorial review, feedback, and guidance on department SOPs
• Collaborate with cross-functional teams to ensure scientific accuracy and alignment across deliverables

Senior Medical Writer

• Prepare high-quality regulatory documentation for client submissions
• Contribute to authorship of documents across different service lines
• Lead projects and author regulatory documents for client engagements
• Mentor others in regulatory document authoring
• Author and lead Modules 3 and Module 2.3
• Serve as document lead for submission-level documents
• Provide subject matter guidance on document preparation, review, comment resolution, and finalization
• Lead project teams toward goals within timelines and budgets
• Build professional client relationships and support business relationships
• Identify and institutionalize effective work practices
• Resolve sensitive or high-pressure project problems
• Transfer knowledge across the organization

Principal Medical Writer – CMC Focus

• Partner closely with Clinical Scientists on protocols and protocol amendments
• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies with minimal supervision
• Coordinate medical writing activities across departments
• Lead resolution of client comments
• Write clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and act as an internal peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and resolve issues, escalating as appropriate
• Provide technical support, training, and consultation
• Mentor and lead less experienced medical writers
• Develop expertise in industry topics and regulatory requirements
• Monitor budgeted hours and communicate status and changes to medical writing leadership
• Complete required administrative tasks and other assigned duties

Sponsor Dedicated Protocol Medical Writer II/Sr

• Prepare high-quality documentation for regulatory submissions to streamline the regulatory documentation process for clients
• Contribute to authorship of various documents across different service lines
• Lead projects and contribute as an author for all types of client engagements
• Mentor others in authoring regulatory documents
• Lead submission-level sections for clinical documents, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE
• Lead sub-teams for pharmacovigilance and transparency and disclosure deliverables
• Take responsibility for clarity of purpose and lead others toward common goals within timelines and budgets on complex projects
• Manage crisis communications and risks
• Identify and promptly address potential problems, particularly in sensitive or high-pressure situations
• Integrate expertise across multiple therapy areas to deliver business successes and transfer knowledge across the organization

Principal Medical Writer – Clinical Focus

• Research, write, and edit manuscripts, abstracts, slide presentations, posters, and other medical communications deliverables
• Collaborate on highly visible client projects involving pharmaceutical products and medical technologies
• Work with the Medical Communications team on publication projects
• Review study data and distill it into thorough, well-written deliverables
• Communicate with team members to achieve content development goals
• Deliver work by designated deadlines and follow the project development process
• Save all deliverable versions according to standardized file-naming criteria
• Work respectfully and productively with internal teams
• Ask supervisors for assistance when appropriate

Senior Medical Writer – Publications

• Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
• Organize, analyze, interpret, and present scientific and statistical information
• Ensure documents comply with ICH, other regulatory guidelines, and company document standards
• Work under the direction of Medical Writing management
• Collaborate with cross-functional internal and external document production teams

• Independently plan and prepare a range of regulatory documents and medical communications supporting all phases of product development.
• Organize, analyze, interpret, and present scientific and statistical information in accordance with ICH and other regulatory guidelines and company document standards.
• Work under the direction of Medical Writing management.
• Collaborate with cross-functional internal and external document production teams.

Principal Medical Writer

• Lead clear and accurate medical writing deliverables and manage writing activities across departments
• Lead resolution of client comments
• Complete protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and resolve issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standard practices, and capabilities
• Mentor and lead less experienced medical writers
• Develop expertise in industry topics and regulatory requirements
• Monitor assigned project budgets and communicate status and changes to medical writing leadership
• Complete administrative tasks and other assigned duties
• Minimal travel may be required, less than 25%

Senior Medical Writer – Regulatory Focus

• Lead the development and execution of medical writing strategies for clinical research projects
• Prepare, review, and edit clinical study protocols, clinical study reports, investigator brochures, regulatory submissions, and other clinical documents
• Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams
• Interpret and analyze clinical trial data and summarize scientific findings
• Participate in planning and execution of clinical development programs
• Provide strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives
• Contribute to publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences
• Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles
• Foster excellence, collaboration, and continuous learning within the medical writing team