Senior Medical Writer

Perceptive Inc.

. Create, research, edit and coordinate production of clinical documents related to independent review .

Posted 9/23/2026full-timeRemote • United StatesSenior💰 $84,368 - $120,526 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drafting, editing, and coordinating clinical documents while ensuring compliance with FDA, EMA, and ICH-GCP guidelines. Proven ability to manage stakeholder relationships and project timelines effectively in a fast-paced, regulated environment.

Highest-signal resume keywords

Clinical Document PreparationRegulatory Submission ExperienceKnowledge of ICH-GCP GuidelinesProject Management SkillsFluent English Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document DraftingMedical EditingRegulatory Document PreparationCritical ThinkingProcess ImprovementAttention to DetailAgile MethodologiesData AnalysisQuality ControlLiterature Review

Soft Skills

Stakeholder EngagementNegotiation SkillsTeam CollaborationProblem SolvingTime Management

Tools & Technologies

Microsoft Office SuiteTableauPower BI

Industry Keywords

Life SciencesClinical ResearchContract Research OrganizationPharmaceuticalBiotechnology

Tech Stack

Tools & technologies

Tableau

About the role

Key responsibilities & impact

Create, research, edit and coordinate production of clinical documents related to independent review
Prepare clinical documents for submission to regulatory authorities
Prepare clinical documents not intended for regulatory submission
Revise drafts based on review comments from team members
Follow SOPs, templates, guidelines, regulations, client instructions and applicable processes
Perform literature searches and reviews for background information and training
Draft or ghost-write clinical documents for more experienced medical writers
Support team members to ensure documentation is accurate and meets stakeholder needs
Participate in process improvement and training initiatives, including development of SOPs, central content, guidelines and workflow procedures
Participate in marketing initiatives such as white papers, abstracts, posters and manuscripts
Serve as primary client contact for medical writing projects
Negotiate deliverable timelines and resolve project-related issues
Represent medical writing on assigned project teams and facilitate authoring team meetings
Coordinate and conduct interdepartmental reviews of draft and final documents
Evaluate task progress, identify issues, facilitate resolutions and advance documents to approval
Distribute final documents to project teams and clients on agreed timelines
Identify project challenges and raise them with stakeholders, suggesting resolution options
Attend project team meetings and maintain project documentation
Provide project management of contractual and financial aspects when required
Implement stakeholder engagement and communications plans
Manage problems, issues, resolutions, corrective actions and lessons learned
Collect and use stakeholder feedback to measure relationship-management effectiveness
Develop and enhance customer and stakeholder relationships
Develop, maintain, control and distribute documents using systematic quality methods
Prepare documents for publishing readiness and ensure consistency and integrity
Ensure documentation adheres to FDA, EMA and other applicable regulatory guidelines and SOPs
Perform medical editing reviews of draft and final documents, including copyediting and content review
Control updates and distribution of quality standards
Carry out other reasonable duties as requested

Requirements

What you’ll need

Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience
Fluent English, written and verbal
Non-English language, written and verbal, desirable
Solid professional experience in the same or very similar role
Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications
Experience working in and knowledge of the life sciences sector
Solid knowledge of industry guidelines and regulations, including ICH-GCP
Experience of regulated environments
Understanding of Agile methodologies
Experience using tools to communicate progress to stakeholders
Proven ability to use Microsoft Office products, including Word, Excel and PowerPoint
Demonstrable ability to apply critical thinking to problems and tasks
Ability to consistently produce documents of high quality
Ability to manage multiple and varied tasks and prioritize workload with attention to detail
Ability to work methodically in a fast-paced, time-sensitive environment
Ability to identify and implement process improvements
Ability to negotiate on behalf of medical writing to align resources, timelines and expectations
Up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements affecting technology within the life sciences domain
Ability to work under own initiative
Experience using data analysis tools such as Tableau or Power BI desirable

Benefits

Comp & perks

Medical, Dental and Vision benefits for you and your family
Flexible Spending Accounts (FSA)
Health Savings Accounts (HSAs)
Paid time off policy including holidays and sick time
Internal growth and development programs & trainings
401(k) program
Life & accident insurance
Disability insurance