Why is remote work so nice? Let's try to see!
Apply
Medical Writer
Posted about 1 month agoInactiveViewed
💎 Seniority level: Middle, 3 years
📍 Location: United States
🔍 Industry: Healthcare
🏢 Company: Cream City Studios
🗣️ Languages: English
⏳ Experience: 3 years
Requirements:
- Bachelor's degree in Life Sciences, Medical Writing, or a related field; advanced degree preferred.
- Minimum of 3 years of experience in medical writing or related field.
- Strong knowledge of regulatory requirements and guidelines for clinical documentation.
- Excellent writing, editing, and proofreading skills with a keen eye for detail.
- Ability to communicate complex scientific concepts clearly to various audiences.
- Proficient in Microsoft Office Suite and familiarity with document management systems.
- Strong organizational skills with the ability to manage multiple projects and deadlines.
Responsibilities:
- Create and review clinical study reports, protocols, and informed consent forms.
- Prepare regulatory submission documents in compliance with FDA and EMA guidelines.
- Develop and author scientific publications for peer-reviewed journals.
- Collaborate with cross-functional teams to gather necessary information for documentation.
- Ensure consistency and adherence to internal style guides and template standards.
- Edit, revise, and proofread documents to ensure quality and accuracy.
- Stay updated on industry trends and regulatory changes affecting medical writing.
Related Jobs
Apply
🔥 Medical Writer
Posted about 12 hours ago
🔍 Medical Writing
🏢 Company: ClinChoice
- Minimum bachelor’s degree in any life sciences field,
- 3-5 years of experience in medical writing, or any related field as applicable,
- Can work in a diverse team environment,
- Good analytical and comprehension skills,
- Proficient in time management and can work with minimal supervision,
- Proficient in oral and written English language,
- Proficient in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint)
- Responsible for authoring/reviewing/supporting regulatory documents (which include, but are not limited to, Systematic Literatures as support for Clinical Evaluation Reports, Post-Market Surveillance Reports and Premarket Approval Reports) as per client requirements using the assigned template within an assigned timeline.
- Prepares, writes and edits literature review reports with the aim of synthesizing and analyzing clinical data from medical and scientific publications.
- Participates in all phases of the systematic literature review process, from planning to execution, which include (aside from literature protocol and report writing) literature search, literature screening, literature appraisal and data extraction, and data analysis,
- Ensures template and style guidelines are followed as appropriate,
- Utilizes available software, such as literature processing tools, to perform specific tasks within the scope of work,
- Communicates and collaborates with other team members and client stakeholders to ensure project timelines and quality standards of deliverables are met,
- Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study designs, ensures compliance with medical device regulations globally, and escalates any new or emerging risks
Posted about 12 hours ago
ApplyApply
🔥 Medical Writer - Medical Communications
Posted about 15 hours ago
📍 United States
🧭 Full-Time
💸 69600.0 - 104400.0 USD per year
🔍 Medical Communications
🏢 Company: Precision AQ
- Advanced Science Degree (PharmD, MD, PhD)
- Proficiency in using Microsoft Word®, PowerPoint®, Excel®, Adobe Acrobat®, and reference-management software (eg, EndNote®)
- 0-3 years relevant experience
- Generate content outlines that contain a clearly highlighted story arc and a complete reference list.
- Develop client-ready drafts of content in various forms (slide decks, executive and comprehensive summaries, and other meeting materials).
- Organize and annotate references in accordance with client’s directives or house style.
- Confer with the teams in the medical/legal/regulatory (MLR) review process, answering all queries from the MLR review committee, and understand and implement the required changes.
Data AnalysisCommunication SkillsMicrosoft Office SuiteResearchWritingPowerPoint
Posted about 15 hours ago
ApplyApply
🔥 Medical Writer
Posted 1 day ago
📍 United Kingdom
🔍 Medical Communications
🏢 Company: ApotheCom
- Excellent and versatile scientific writing and editing skills
- Experience developing content for different medical audiences
- Create materials to a high standard and quality, with minimal internal review/assistance
- Experience writing in a range of media, including print, video, new media (CD-ROM and web-based work)
- Excellent quality control skills – style/consistency, grammar, scientific accuracy, proof-reading, layout.
- Ensure all writing meets our client's strategic marketing goals and being of high scientific quality/credibility
- Understanding of pharmaceutical and health-related issues
- Ability to work within a team and form productive working relationships within, and external to, iNIZIO
- Client-centric attitude - ability to work with clients on projects, ensuring they meet strategic marketing and medical needs
- Research and developing technical material
- Ensuring that all output follows written brief, is accurate in content and editorial style and can be referenced
- Partnering with clients and KOL's on content development either through the Account staff or directly
- Attending scientific meetings where output is required
Content creationCommunication SkillsAnalytical SkillsResearchWritingClient relationship managementEditing
Posted 1 day ago
ApplyApply
🔥 Medical Writer- Remote opportunities
Posted 1 day ago
🔍 Pharmaceutical
- Minimum of 3 years of experience writing clinical and regulatory documents for drugs, biologics, medical devices/diagnostics for a CRO, pharmaceutical company, or biotechnology company.
- Knowledge of clinical research principles and the ability to interpret and present clinical data and other complex information.
- Understanding of global regulatory bodies and applicable regulations and guidelines.
- Understanding of regulatory submission requirements and processes.
- Author (write / edit) high-quality regulatory writing deliverables
- Adhere to established regulatory standards / guidelines
- Strive to complete writing deliverables on time and within budget.
- Interact and communicate directly with clients, lead team meetings
- Interact and collaborate as needed with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
- Coordinate QC reviews of documents and maintain audit trails of changes as applicable.
- Review statistical analysis plans and table / figure / listing shells (as applicable) for appropriate content, grammar, format, and consistency.
- If requested by supervisor, perform QC review (e.g., reviews in-text tables against statistical output).
- Assist with project-related administrative tasks (e.g., creating and maintaining timelines, updating deliverable trackers, and hosting internal / client meetings) with support from senior personnel (as needed).
- Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
- Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out-of-scope tasks to regulatory writing leadership.
Posted 1 day ago
ApplyApply
🔥 Associate Principal Medical Writer
Posted 29 days ago
📍 Europe, US, APAC
🧭 Full-Time
🔍 Medical Communications
🏢 Company: Nucleus Global👥 501-1000PharmaceuticalConsultingMedical
- Previous experience working in a Medical Writing role, within a medical communications agency environment
- An academic background in the life sciences
- Experience writing across a broad range of scientific deliverables
- Reviewing and line management experience
- Researching and developing technical materials, ensuring that all outputs follow written brief, are accurate in content and editorial style and can be referenced
- Communicate with clients and KOL on content development
- Attend several scientific meetings
Research
Posted 29 days ago
ApplyApply
🔥 Senior Medical Writer
Posted about 1 month ago
💸 140000.0 - 157000.0 USD per year
🔍 Biotech/pharmaceutical
🏢 Company: Spyre Therapeutics👥 1-50💰 $180,000,000 Post-IPO Equity over 1 year agoBiotechnologyTherapeutics
- A minimum of 4+ years of regulatory medical writing experience within the biotech/pharmaceutical industry.
- Proven track record of successfully managing clinical study protocols, their amendments, study reports, investigator’s brochures, and other key clinical and regulatory submission documents.
- Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.
- Excellent leadership, collaboration, communication, and interpersonal skills.
- Strong problem-solving and critical thinking abilities.
- Ability to meet deadlines and adapt to changing priorities.
- Proficiency in word processing software and document management systems.
- Author clinical study protocols, amendments, IBs, and other supporting documents
- Review or develop timelines for clinical documents in collaboration with our team and our CROs. Ensure that protocols will be authored, reviewed, and finalized in time for regulatory submission(s) and study execution.
- Co-author protocols and IBs with cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments).
- Coordinate the finalization and publication of documents.
- Author CSRs and data summaries for INDs, CTAs, BLAs, and MAAs
- Work closely with the clinical development, translational science, data management, and/or biometrics SMEs, as well as the regulatory affairs and medical writing teams, to plan for the data that we expect to report in our CSRs. Co-author robust CSR shells in preparation for database lock(s).
- Co-author CSRs with accurate and concise interpretations of the results. Manage review cycles.
- Prepare written summaries for submission to regulatory agencies. Ensure key messages are clear and consistent across and within documents.
- Coordinate data integrity reviews of CSRs and data summaries, ensuring that the data and interpretations are consistent with TLFs and raw data.
- Identify risks and contribute to risk mitigation or contingency planning for submission activities.
- Contribute to the maintenance of document templates, job aids, and training materials. Identify opportunities for process improvement.
- Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.
- Other duties as assigned.
Posted about 1 month ago
ApplyApply
🔥 Senior Medical Writer (Medical Communications/Commercial)
Posted 3 months ago
📍 United States
🔍 Healthcare, Medical Communications
🏢 Company: OPEN Health👥 1001-5000💰 $1,300,000 Pre-seed about 1 year agoDatabaseConsultingMedicalHealth Care
- Strong scientific understanding (PharmD or PhD preferred) and excellent writing skills.
- Multiple years of agency experience drafting Medical Communication documents.
- Ability to interpret and write from clinical trial protocols and clinical study reports.
- Good ability to interpret and describe scientific statistics.
- Proficiency in communicating complex scientific ideas in a simple manner.
- Skill in managing multiple priorities and setting expectations.
- Confidence and professionalism when interacting with clients and experts.
- Enthusiasm, team-player attitude, and self-motivation.
- Proficiency with PubMed searches and MS365 programs.
- Providing research and writing support to assigned brand teams and new business efforts.
- Working independently and as part of a multidisciplinary team.
- Producing slide presentations, executive meeting summaries, and other materials.
- Writing scientifically accurate, fully referenced materials.
- Interacting with key experts to solicit input and resolve queries.
- Researching medical topics and maintaining knowledge in relevant therapy areas.
- Incorporating revisions based on feedback and communicating about deadlines.
- Contributing strategic recommendations for quality improvement.
ResearchWriting
Posted 3 months ago
ApplyApply
🔥 Senior Medical Writer
Posted 5 months ago
📍 Japan
🔍 Medical communications
🏢 Company: MEDiSTRAVA
- Fluent in written and conversational Japanese.
- Ability to quickly learn new therapeutic areas and understand competitor therapies.
- Demonstrate excellent scientific writing and editing skills.
- Experience creating content for various healthcare medical audiences.
- Proven ability to produce high-quality materials with minimal review.
- Experience writing in multiple media formats including print, video, and web.
- Strong quality control skills for style, consistency, grammar, and scientific accuracy.
- Familiar with local, regional, and global codes of practice for medical communication.
- Ability to work collaboratively within a team and build productive relationships.
- Strong client-centric attitude with a track record of meeting client strategic goals.
- The Senior Medical Writer will research technical materials and clinical situations.
- Develop content for diverse healthcare audiences in line with client objectives.
- Ensure all content is accurate and supported by robust evidence.
- Collaborate with external experts and internal teams to maximize relevance.
- Attend client planning meetings and external scientific events when necessary.
- Work closely with the wider MEDiSTRAVA team across different locations.
Communication SkillsAnalytical SkillsCollaboration
Posted 5 months ago
ApplyApply
🔥 Medical Writer (CER)
Posted 6 months ago
📍 EU, UK
🧭 Contract
🔍 Medical/Healthcare
🏢 Company: Cross Border Talents👥 251-500💰 $75,919 Grant over 9 years agoStaffing AgencyConsultingHuman ResourcesRecruiting
- EU citizen living in any country of EU or UK.
- Proficient in English grammar/sentence structure.
- Between 02 to 05 years of experience as Medical Writer (recent).
- Strong background in Clinical and/or Medical Devices.
- At least 02 years of experience in writing Clinical Evaluation Reports (CER) or Post-Market Surveillance Reports (PMSR).
- Good knowledge in drafting literature review and state of art documents.
- Good knowledge of MEDDEV Rev. 4 guidance.
- Used to perform scientific literature searches in different databases.
- Experience in reviewing scientific literature.
- Understand about Medical Device Regulations (MDR).
- Perform scientific literature searches and collection of research articles from appropriate databases (e.g. PubMed and other search engines).
- Perform literature and database searches, reviews articles to extract relevant information, and summarizes information from identified articles.
- Demonstrate sound knowledge of the medical writing process, medical device regulations, and associated approval processes.
- Apply medical concepts and terminology appropriately.
- Update project-related tracking tools.
- Work with multiple teams to collect documents as required.
- Maintain records for all assigned projects, including archiving.
- Schedule and conducts document-related meetings, including the preparation of meeting agendas, key data points for discussion, and meeting minutes.
- Work closely with the study team to ensure that content and results in clinical documents are accurate and complete as required.
Data AnalysisCommunication SkillsAnalytical SkillsCollaboration
Posted 6 months ago
ApplyRelated Articles
Posted 7 months ago
Insights into the evolving landscape of remote work in 2024 reveal the importance of certifications and continuous learning. This article breaks down emerging trends, sought-after certifications, and provides practical solutions for enhancing your employability and expertise. What skills will be essential for remote job seekers, and how can you navigate this dynamic market to secure your dream role?
Posted 7 months ago
Explore the challenges and strategies of maintaining work-life balance while working remotely. Learn about unique aspects of remote work, associated challenges, historical context, and effective strategies to separate work and personal life.
Posted 7 months ago
Google is gearing up to expand its remote job listings, promising more opportunities across various departments and regions. Find out how this move can benefit job seekers and impact the market.
Posted 7 months ago
Learn about the importance of pre-onboarding preparation for remote employees, including checklist creation, documentation, tools and equipment setup, communication plans, and feedback strategies. Discover how proactive pre-onboarding can enhance job performance, increase retention rates, and foster a sense of belonging from day one.