CrawlJobs Logo

Senior Medical Writer

iconplc.com Logo

iconplc

Location Icon

Location:

Category Icon
Category:
IT - Software Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

Job Responsibility:

  • Deliver high quality relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports), as well as CSRs, protocols, and other documents, within the required regulatory system per global aligned procedures of the client
  • Write clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
  • Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers
  • Provide scientific and medical writing consultancy to project teams, as requested
  • Services rendered will adhere to applicable client’s SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
  • Ensure clear communication with clinical pharmacology & pharmacometric leaders and other team members
  • Ensure deliverables are inspection ready and compliant with relevant requirements
  • Maintain the central planning of population PK/PD document writing and QC deliverables

Requirements:

  • Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
  • Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
  • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
  • Excellent writing, editing, and proofreading skills
  • Ability to communicate scientific concepts to diverse audiences
  • Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
  • Experience in interacting with regulatory agencies during the review and approval process
  • Demonstrated ability to work effectively in a fast-paced, deadline-driven environment
  • Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables
  • Excellent interpersonal and communication skills
  • Ability to collaborate effectively with cross-functional teams
  • Ability to build relationships with key stakeholders
  • Ability to influence decision-making processes
What we offer:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Additional Information:

Job Posted:
February 17, 2026

Work Type:
Remote work
Icon
iconplc - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Medical Writer

Senior Healthcare Content Writer

Our client, a leader in the healthcare insurance space, is seeking a highly skil...
Location
Location
United States , Atlanta
Salary
Salary:
Not provided
tier4group.com Logo
Tier4 Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A Bachelor’s degree, preferably in English, Journalism, Marketing or communications
  • Minimum of 7-10 years’ experience
  • Corporate experience with the ability to interact with C-level executives
  • Superior creative and technical writing and grammar skills
  • Experience in medical or healthcare communications and writing with a strong understanding of medical terminology and healthcare industry practices
  • Proven ability to translate complex analyses into engaging, clear, and impactful content
  • Understanding of SEO and writing meta data, keywords, and alt text
  • Knowledge of MS Office applications including Word and PowerPoint
  • Openness to a rapidly changing and growing environment
  • A self-starter that’s able to work both independently and collaboratively on multiple projects concurrently
Job Responsibility
Job Responsibility
  • Research and write articles, white papers, reports, presentations, courses, and other content primary for the website, but channels also could include print, video, social, email, and more
  • Work with analytics team to highlight liability risk and incorporate analytics insights throughout content
  • Edit learning content developed by medical and legal faculty
  • Collaborate with the Chief Medical Officer, Director, Advice Content Strategy, and subject matter experts to research and develop ideas for new content
  • Work closely with the marketing team to optimize copy for digital channels, including SEO
  • Deliver work that reflects a careful attention to detail and adherence to legal and brand guidelines
  • Fulltime
Read More
Arrow Right

Senior Content Manager

Lead the development, review, and delivery of high-impact medical education cont...
Location
Location
Canada , Toronto
Salary
Salary:
Not provided
fullscript.com Logo
Fullscript
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 8+ years in medical writing and editing, preferably with a focus on practitioner education
  • Deep understanding of scientific writing standards, editorial best practices, and regulatory requirements
  • Proven ability to write across modalities and tones—from protocols to presentations to podcast scripts
  • Confidence collaborating with freelancers and SMEs, setting expectations, and providing editorial direction
  • Familiarity with using AI tools to support content development, with strong human oversight
Job Responsibility
Job Responsibility
  • Create and oversee the development of evidence-informed educational content for healthcare professionals
  • Direct freelance medical writers, providing clear outlines, editorial guidance, and constructive feedback
  • Collaborate cross-functionally with internal teams and stakeholders to shape content formats and delivery strategies
  • Tailor content for diverse audiences and formats
  • Ensure quality and compliance by conducting or reviewing literature searches, validating accuracy of claims, reviewing for FTC/FDA compliance, and adhering to internal style and compliance guidelines
  • Conduct clear content intake processes to define context, audience, CME requirements, and format
  • Identify opportunities to improve workflows for editing, reviewing, and approving medical content
  • Ensure content quality and utility by measuring performance, applying insights, and adapting content to better meet user needs and maximize impact
  • Fulltime
Read More
Arrow Right

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...
Location
Location
United States
Salary
Salary:
152684.00 - 193308.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of directly related experience
  • Master’s degree and 6 years of directly related experience
  • Bachelor’s degree and 8 years of directly related experience
  • Associate’s degree and 10 years of directly related experience
  • High school diploma / GED and 12 years of directly related experience
  • Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
  • 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry
Job Responsibility
Job Responsibility
  • Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
  • Conduct the formal review and approval of authored documents, following applicable standard operating procedures
  • With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
  • Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
  • Provide functional area input for Global Regulatory Plan and team goals
  • Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
  • Lead departmental and cross-departmental initiatives, as appropriate
  • Generate document timelines
What we offer
What we offer
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
  • Fulltime
Read More
Arrow Right
New

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and documen...
Location
Location
United States , San Rafael
Salary
Salary:
116000.00 - 159500.00 USD / Year
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility
  • Experience writing, reviewing, or editing protocols and clinical study reports required
  • Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
  • Experience writing, reviewing, or editing regulatory briefing books preferred
  • Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
  • Ability to interpret and create complex tabular and graphical clinical data presentations
  • Advanced applied knowledge of basic clinical laboratory tests
  • Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
  • Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets
  • Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
Job Responsibility
Job Responsibility
  • Applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.)
  • Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)
  • Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams)
  • Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
  • Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
  • Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
What we offer
What we offer
  • Discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Paid time off
  • Company-sponsored medical, dental, vision, and life insurance plans
  • Fulltime
Read More
Arrow Right

Senior / Principal Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...
Location
Location
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
  • Excellent interpersonal, negotiation, verbal, and written communication skills
  • A flexible attitude with respect to work assignments and new learning
  • Motivation to work consistently in a fast-paced, rapidly changing environment
  • Ability to manage multiple / varied tasks with enthusiasm and prioritize workload with attention to detail
  • Competent working in a matrix environment and values the importance of teamwork
  • Possesses team leadership skills and cross-cultural sensitivity
  • Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate
  • Presents solutions and follows through to ensure problems have been satisfactorily resolved
  • Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned
Job Responsibility
Job Responsibility
  • Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training
  • Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
  • Manage ongoing and/or revised project documentation and correspondence
  • Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
  • Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission
  • Project Management: Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents
  • Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project
  • Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences
  • Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence
  • Client Liaison/Service: Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management
What we offer
What we offer
  • Structured career pathway and encouragement to develop within the role including awareness and understanding of the industry
  • Competitive base salary
  • Holiday
  • Private healthcare
  • Other benefits that you would expect with a top company in the CRO Industry
Read More
Arrow Right
New

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and documen...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
February 18, 2026
Flip Icon
Requirements
Requirements
  • Bachelor’s or higher degree required, scientific focus desirable
  • Minimum requirement: Experience in medical writing
  • Evidence of medical writing career development desirable, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association
  • Up to 6 years of as a medical writer in the pharmaceutical industry OR At least 10 years of medical or scientific writing experience as a primary job responsibility
  • Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets
  • Direct experience with documentation in all phases of drug development
  • Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection
  • Intermediate to advanced applied knowledge of: Documentation required for the conduct of clinical studies
  • Protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
  • Study results reporting
Job Responsibility
Job Responsibility
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.)
  • Drafts and edits documents used in the preparation of regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)
  • Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Represents Global Medical Writing at cross-functional team meetings (e.g., study team, development team, other sub teams)
  • Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
  • Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
  • Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
  • Works effectively with cross-functional groups within BioMarin
  • Fulltime
Read More
Arrow Right

Medical Affairs Medical Writer

Medical Affairs is responsible for ensuring the safety and efficacy of Medicatio...
Location
Location
United States , Sandy, UTAH
Salary
Salary:
39.00 - 41.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in a relevant Medical Device Industry required
  • Minimum of 2-3 years writing experience within the Medical Device Industry.
  • Superior attention to detail.
  • Ability to write with scientific accuracy
  • Ability to compile, write, edit, and format documents for submission to regulatory agencies. (Writing samples required)
  • Ability to assist with comprehensive literature searches as needed.
  • Understanding of MEDDEV 2.7/1 rev4 guidelines and the MDR regulations related to clinical evaluation reports preferred.
  • Ability to ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines
  • Excellent written and verbal communication skills.
  • Proficiency in MS Office with expertise in Microsoft Word with a special focus on word processing, use of templates, and formatting. Working knowledge of Excel.
Job Responsibility
Job Responsibility
  • Combine knowledge of science with understanding of research and writing to present information effectively and with clarity.
  • Focus on scientific medical writing to prepare documents – clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) – for submission to regulatory bodies.
  • Collaborate with other functions and with the Senior Medical Writer as necessary to ensure accurate and timely completion and review of clinical documents for regulatory submissions.
  • Assist with and / or compile, review and summarize, available data to access the safety and efficacy of MDS products worldwide.
  • Fulltime
Read More
Arrow Right

Senior Medical Writer

The Senior Medical Writer: 1) writes original content for publications activitie...
Location
Location
United States , West Chester
Salary
Salary:
Not provided
synchronygroup.com Logo
Synchrony Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD, PharmD, or MD
  • Minimum of 3 years’ experience in medical communications
  • Substantial professional medical writing experience in a wide variety of communication formats
  • Ability to work independently on assigned projects
  • Excellent attention to detail and high degree of scientific and medical accuracy
  • Ability to manage outcomes to win-win resolution
  • Ability to identify key issues and to creatively and strategically overcome challenges or obstacles
  • High level of integrity, ethics, confidentiality, and accountability
  • Sound analytical thinking, planning, prioritization, and execution skills with an ability to multitask
  • Well-developed professional communication skills, including written and interpersonal
Job Responsibility
Job Responsibility
  • Demonstrate a command of assigned therapeutic areas and expertise with assigned products
  • Write original content for publication/communication activities (primary and review manuscripts, abstracts, posters), slide presentations, meeting summaries, and other materials for HCP and internal audiences
  • Prepare materials according to internal writing guidelines and other applicable guidelines (eg, client-specific style guidelines, compliance best practices, journal style guidelines)
  • Follow all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices, including GPP3
  • Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed
  • Interpret and apply clinical data
  • Maintain a proactive approach on initiatives for existing and prospective clients
  • Work in conjunction with team members to manage workload and develop and adhere to logical and attainable timelines for project completion
  • Attend team meetings to provide input and aid in troubleshooting/problem-solving
  • Efficiently and accurately collate and incorporate author/client comments
What we offer
What we offer
  • Competitive salaries
  • Generous paid time off
  • Excellent health insurance
  • Family leave
  • 401(k) plan with employer matching
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy