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Senior Editor, ME
American Society of Mechanical Engineers 4.4
Remote medical editor job
ASME helps the global engineering community develop solutions to real-world challenges. Founded in 1880 as The American Society of Mechanical Engineers, ASME is a nonprofit professional organization that enables collaboration, knowledge sharing, and skill development across all engineering disciplines, while promoting the vital role of the engineer in society. ASME codes and standards, publications, conferences, continuing education, and professional development programs provide a foundation for advancing technical knowledge and a safer world. From college students and early-career engineers to project managers, corporate executives, researchers, and academic leaders, ASME's members are as diverse as the engineering community itself.
We are seeking a Senior Editor to join our team and share in their passion for Mechanical Engineering. Working with the Managing Editor of Mechanical Engineering, the Senior Editor will be responsible for developing and implementing new streams of editorial content for our Mechanical Engineering magazine within print, digital, and multimedia platforms, with an aim of increasing the acquisition, engagement, and retention of ASME members.
Responsibilities include:
Work with the Managing Editor, Mechanical Engineering, and within the editorial team to help conceive, edit, develop, and produce new content for various ASME media platforms, including Mechanical Engineering magazine and ASME.org, as well as other content-based member benefits such as white papers, newsletters, blogs, and technical digests.
Help define approaches to articles and be a strong sounding board when it comes to technical topics and direction of coverage.
Ideate, write, edit, and publish content pieces, including longform articles, across various ASME print and digital platforms.
Assist the Managing Editor, Mechanical Engineering to identify, manage and develop freelance writers and editors, determining clear roles and responsibilities, in line with the editorial mission, voice and tone.
Work with internal and/or external creatives to shepherd creative assets (photo, video, illustration, graphic design) from start to finish.
Serve as the project manager for the editorial and creative teams on assigned projects.
Partner with our analytics team to analyze content performance and apply learnings to apply to future content roadmap, including data from past campaigns, SEO research, and audience behavior.
Lead the editorial team's social media and audience outreach efforts and ensure that the editorial team's content strategy fits cohesively with ASME's member content strategy.
Monitor and stay current on trends-technical, legislative, and business-that impact ASME members and the industries where mechanical engineers work.
Conduct on-camera interviews or moderate/ hosting live and virtual event sessions and webinars; serve as an on-camera reporter and narrator as needed to support projects.
This role requires a bachelor's degree or additional equivalent work experience with a minimum of 5 years' experience in technical journalism, including editing and feature writing. Experience within engineering or a related field is preferred.
Additionally, a proven track record of demonstrating knowledge, excellence and practical experience in the following technical and professional skills and competencies is required:
Communication - Oral and written presentation, including the ability to clearly explain technical concepts to non-technical audiences and demonstrated excellence in feature news-type writing skills.
Relationship Management - Ability to work well with teams in diverse, complex, and changing environments
Problem Solving - Ability to identify key issues, gather data to investigate those issues, and develop actionable recommendations
Project Management - A detailed approach and ability to work independently and remain organized in order to meet commitments and balance competing priorities
Technical:
Knowledge of science and its practical application as technology - particularly within the areas of bioengineering, advanced manufacturing, robotics, energy, and engineering professional development and workforce topics.
Demonstrated skill at managing digital workflows for media site is required - CMS systems/Adobe Creative Suite.
This role is eligible for a remote work arrangement. Periodic business travel may be required, including but not limited to, ASME offices, globally.
ASME is proud to be an Equal Opportunity Employer. At ASME, we nurture an inclusive environment, and we encourage, support, and celebrate diversity in the workplace. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex (including pregnancy), national origin, age, gender identity & expression, sexual orientation, genetic information, citizenship status, disability, or protected veteran, military status, or any other basis protected by law.
Our Equal Employment Opportunity policy pertains to every aspect of an individual's relationship with the organization, including but not limited to recruitment, hiring, compensation, benefits, training and development, promotion, programs, and all other terms and conditions of employment.
Annual base salary may vary based on geographic location. The New York metro salary range for this position is estimated to be between $90,000 - $105,000 per year.
Only those candidates selected for further consideration will be contacted.
$90k-105k yearly 2d ago
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Remote Social Media Video Editor (Project based)
Psiquantum 4.2
Remote medical editor job
PsiQuantum'smission is to build the first useful quantum computers-machines capable of delivering the breakthroughs the field has long promised. Since our founding in 2016, our singular focus has been to build and deploy million-qubit, fault-tolerant quantum systems.
Quantum computers harness the laws of quantum mechanics to solve problems that even the most advanced supercomputers or AI systems will never reach. Their impact will span energy, pharmaceuticals, finance, agriculture, transportation, materials, and other foundational industries.
Our architecture and approachisbased on silicon photonics. Byleveragingthe advanced semiconductor manufacturing industry-including partners like GlobalFoundries-we use the same high-volume processes that already produce billions of chips for telecom and consumer electronics. Photonics offers natural advantages for scale: photonsdon'tfeel heat, are immune to electromagnetic interference, and integrate with existing cryogenic cooling and standard fiber-optic infrastructure.
In 2024,PsiQuantumannounced government-funded projects to support the build-out of our first utility-scale quantum computers in Brisbane, Australia, and Chicago, Illinois. These initiatives reflect a growing recognition that quantum computing will be strategically and economically defining-and that now is the time to scale.
PsiQuantumalso develops the algorithms and software needed to make these systems commercially valuable. Our application, software, and industry teams work directly with leading Fortune 500 companies-including Lockheed Martin, Mercedes-Benz, Boehringer Ingelheim, and Mitsubishi Chemical-to prepare quantum solutions for real-world impact.
Quantum computing is not an extension of classical computing. Itrepresentsa fundamental shift-and a path to mastering challenges that cannot besolvedany other way. The potential is enormous, and we have a clearpathto make it real.
Come join us.
Job Summary:
We're looking for a social media-savvy remote Freelance Junior Video Editor to help repurpose our existing content library for digital platforms. You'll work closely with our VideoProducer to transform longer-form interviews and branded content into engaging social media edits.
Responsibilities:
Edit short-form content (reels, stories, clips) from existing edits and raw footage for LinkedIn, Instagram, Twitter/X, and other social platforms.
Create multiple cutdowns and variations of existing video content optimized for different platforms and audiences.
Add captions, subtitles, graphics, and on-brand text overlays.
Stay current on social media trends, formats, and best practices across platforms.
Organize and manage footage libraries and project files.
Collaborate on creative approaches to maximize engagement and reach.
Light color correction and audio mixing as needed
Experience/Qualifications:
Ideal Candidate:Someone who lives and breathes social media, understands platform-specific editing styles, and can work independently to create thumb-stopping content. Adobe Premiere Pro experience required. After Effects experience is a plus.
Technical Requirements:Fast/fiber internet connection is essential for remote editing workflows.
*******In order to be considered for this opportunity, applicants must provide a link to your reel*********
PsiQuantum provides equal employment opportunity for all applicants and employees. PsiQuantum does not unlawfully discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws.
Note: PsiQuantum will only reach out to you using an official PsiQuantum email address and will never ask you for bank account information as part of the interview process. Please report any suspicious activity to .
We are not accepting unsolicited resumes from employment agencies.
$48k-69k yearly est. 4d ago
Senior Medical Editor - Regulatory - Home Based
Syneos Health, Inc.
Remote medical editor job
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
* We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
* Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
* Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed.
* Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
* Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medicaleditors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles.
* Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable.
* Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process.
* Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices.
* Performs quality review of assigned documents to ensure accuracy.
* Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
* Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
* May compile medical writing deliverables.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$62,000.00 - $108,600.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
***************************
Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Improves and ensures the quality of compliance of written deliverables through copyediting, quality review, and document management. Provides advanced editorial guidance and technical expertise in the writing, production, and/or review of regulatory and other scientific/clinical documents. Independently performs advanced quality review or compilation tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Leads editorial team for large deliverables requiring multiple editors. Interacts with medical writing leadership and staff regarding assigned deliverables as appropriate. Provides training and mentoring to other medical editing staff members.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
•Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
•Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed.
•Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
•Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medicaleditors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles.
•Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable.
•Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process.
•Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices.
•Performs quality review of assigned documents to ensure accuracy.
•Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
•Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
•May compile medical writing deliverables.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$62,000.00 - $108,600.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
***************************
Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
$62k-108.6k yearly Auto-Apply 46d ago
Medical Editor - Market Access Marketing
Precision AQ
Remote medical editor job
Precision AQ - Market Access Marketing, the top payer marketing agency, supports global pharmaceutical and life sciences clients in the achievement of commercial excellence. We excel at demonstrating the economic, clinical, and societal value of creative medical treatments to payers, providers, patients, and policymakers. As leaders in the generation, analysis, and communication of that evidence, we are improving market access and supporting our clients in their mission of improving care for patients around the world.
About You:
If “Error-free” is your mantra; you've always enjoyed copy editing and proofreading, from menus to the news page to medical marketing materials.
You follow the rules - leaning on your knowledge of AMA style, FDA guidelines, client preferences, and good writing.
With an insatiable interest in health and medicine, you enjoy continually learning and understanding brands and therapeutic areas.
You are a keen and inquisitive fact checker who loves getting into the nitty gritty to make sure every bit is accurate.
You love collaborating with a team of like-minded professionals, driven to meet deadlines, and committed to quality contributions crucial to the successful execution of print and digital projects for our clients.
You are passionate about your work and adhere to the 3 c's: clear, concise, correct.
You are flexible, able to handle multiple projects at once, and do your best work in an energizing environment.
MedicalEditors partner in the content review process, reviewing and editing content for correct spelling, grammar, and sentence structure, fulfillment of creative brief, adherence to AMA and client style, and appropriate and accurate referencing. You'll be involved at all stages of content development, initiating and maintaining editorial integrity from outline to printer's proof. Editors fact check materials and align with the writers on annotating and referencing. You will represent Editorial at internal start-up and status meetings, and work with the extended team to facilitate project completion. You will ensure all pieces are aligned with each client's MLR submission process and support the MLR process.
Qualifications:
Bachelor's degree in English, Journalism, or similar field
3+ years of editing experience in healthcare and/or pharmaceutical industry required. At least 1 year of experience in the advertising and/or pharmaceutical marketing industry preferred
Editorial experience in the pharmaceutical/medical communication or ad agency field
Thorough knowledge of AMA (11th edition) style
Proficiency with Microsoft Office suite of products as well as familiarity with editing in Adobe Acrobat Professional
Preferred qualifications:
Industry experience to include in advertising, pharmaceutical marketing, medical communications, and/or medical education industry
Familiarity with Veeva, Zinc, or MLR reviews and submissions systems
Knowledge of FDA requirements with respect to pharmaceutical advertising
#LI-Remote
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$54,000-$81,600 USD
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
$54k-81.6k yearly Auto-Apply 1d ago
Principal Medical Writer - GenAI and Regulatory Writing Innovation
This Role This
Remote medical editor job
, candidate must be located within the USA
About This Role
The Principal Medical Writer serves as a scientific communication and innovation leader within Biogen's Medical Writing department, focusing on leveraging Generative AI (GenAI) technologies to transform regulatory writing. In this role, you will combine your expertise in regulatory document strategy with forward-looking approaches to content generation, automation, and AI-enabled writing support.
You will author and oversee preparation of high-quality clinical regulatory documents (e.g., clinical summaries, CTAs, INDs, and briefing packages) and collaborate closely with cross-functional teams to ensure clarity, accuracy, and consistency. Additionally, you will work on collaborative initiatives with internal and external partners to develop and pilot GenAI tools that enhance efficiency, quality, and compliance in medical writing workflows.
Coding experience is not required, but a strong curiosity and comfort with GenAI tools (e.g., ChatGPT, Claude, Gemini, Copilot, etc.)-and an ability to apply them in daily work-will be key to success.
What You'll Do
Provide medical writing leadership and authoring expertise for assigned program(s), ensuring timely delivery of regulatory and clinical documents of the highest quality.
Lead or contribute to innovation projects applying GenAI to automate and optimize regulatory writing processes in collaboration with internal stakeholders (e.g., Data Science, Regulatory, and Clinical teams) and external partners.
Serve as a GenAI champion within the Medical Writing function-sharing best practices, identifying use cases, and promoting responsible adoption of AI-enabled tools.
Provide strategic input and writing support for major submission documents such as Clinical Overviews, Summaries, and regulatory briefing packages.
Mentor and guide junior writers, providing oversight and feedback on content, timelines, and quality expectations.
Support the development of GenAI training materials and process enhancements to upskill the medical writing team.
Contribute to departmental initiatives that foster innovation, efficiency, and continuous improvement.
Ensure consistency of scientific messaging and alignment with therapeutic area strategy across documents.
Who You Are
You are an experienced regulatory writer who combines deep scientific and communication expertise with an innovative mindset. You are eager to explore how AI can transform regulatory writing and are comfortable experimenting with new technologies to improve workflows. You excel in cross-functional collaboration, balance strategic thinking with hands-on writing, and are passionate about quality, compliance, and innovation.
Required Skills
Bachelor's degree in Life Sciences or a health-related discipline required; advanced degree (MS, PhD, PharmD, MD) preferred.
At least 7 years of experience in the biopharmaceutical industry (advanced degree or academic research may substitute for some experience).
Minimum 5 years of hands-on medical writing experience supporting clinical regulatory submissions (e.g., CTD, IND, NDA/BLA components).
Demonstrated expertise in therapeutic area document requirements and global regulatory standards.
Familiarity with large language models (LLMs) and GenAI applications for writing, summarization, or data interpretation.
Proven ability to manage multiple complex deliverables, work effectively in a matrixed team, and mentor others.
Excellent written and verbal communication skills, with meticulous attention to scientific and regulatory accuracy.
Preferred Skills
Experience or strong interest in applying GenAI tools for writing, document review, or data summarization.
Ability to translate AI capabilities into practical solutions within regulated environments.
Understanding of ethical and compliance considerations for AI use in scientific communication.
Job Level: Management
Additional Information
The base compensation range for this role is: $132,000.00-$176,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families
physical, financial, emotional,
and
social well-being
; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
$132k-176k yearly Auto-Apply 14d ago
Market Access Medical Writer
GLE Creative Talent
Remote medical editor job
Senior Medical Writer and Medical Writer, Market Access
Craft Compelling, Data-Driven Content That Shapes Market Access Strategy Remote Position (EST Hours)
Join a fast-growing, high-impact division within an established, financially stable agency. As a Medical Writer, Market Access, you will play a critical role in developing strategic, scientifically accurate content that drives brand differentiation and maximizes access goals. Working closely with internal teams and clients, youll translate complex clinical data into clear, compelling narratives that support payer engagement and brand success.
Note: This is a remote position. Candidates may be based in PST or CST but must be available to work EST hours (with some flexibility).
Key Responsibilities Content Strategy & Development
Develop a deep understanding of assigned products, therapeutic areas, and competitor landscapes.
Lead content creation efforts, crafting engaging, high-quality materials that support market access strategies with minimal oversight.
Translate complex clinical and health economics data into clear, compelling, and strategically relevant content for a variety of digital and print assets.
Ensure all resources are scientifically accurate, well-referenced, and compliant with regulatory guidelines.
Guide medical/regulatory approval submissions, incorporating client and compliance feedback efficiently.
Identify credible sources and ensure adherence to the agencys standards for referencing and citations.
Proactively explore new, innovative ways to present data, enhancing impact and readability.
Collaboration & Client Engagement
Work closely with Account, Creative, and Market Access Strategy teams to develop content that aligns with client objectives.
Act as a trusted medical resource, supporting internal teams and client discussions with scientific expertise.
Defend content choices and perspectives in client interactions, ensuring strategic alignment and accuracy.
Partner with creative teams to develop accurate and effective visuals that support medical messaging.
Research, Thought Leadership & Operations
Support research and development efforts for new business pitches, contributing to strategic recommendations and the medical portion of proposals.
Educate internal teams on clinical and market access topics, strengthening agency-wide expertise.
Stay informed on industry trends, FDA regulations, and best practices to maintain high standards in content development.
Qualifications
3+ years of experience in medical writing or scientific content development, with a strong focus on market access.
Advanced degree (PhD, PharmD, MD, or equivalent) preferred; strong scientific or clinical background required.
Experience across multiple therapeutic areas; prior launch experience is a plus.
Proven ability to distill complex scientific and economic data into engaging, strategic content.
Strong understanding of FDA marketing regulations, AMA style, and compliance best practices.
Ability to prioritize multiple projects, meet deadlines, and adapt in a fast-paced, collaborative environment.
Excellent communication and stakeholder engagement skills.
Willingness to travel periodically for client meetings or industry events.
Salary & Benefits
Base Salary: $100K - $160K (dependent on experience)
Performance-Based Bonus
Unlimited PTO
Comprehensive Benefits Package
Career growth opportunities in a high-impact, innovative team environment
This is a fully remote opportunity to contribute to a growing, forward-thinking agency where your scientific expertise and writing skills will make a tangible impact. Candidates must be able to work EST hours, flexible for those in PST or CST. We'd love to hear from you if you're passionate about creating high-quality, strategic medical content!
$100k-160k yearly 60d+ ago
Medical Writer - Clinical Compliance
Solventum
Remote medical editor job
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
Medical Writer - Clinical Compliance(Solventum)
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
As a Medical Writer - Clinical Compliance you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit.
Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements.
Supporting internal and external audits as a subject matter expert in clinical evaluations.
Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices.
Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND five (5) years of experience in the medical device industry
Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirements
Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes
Strong scientific writing and communication skills, with the ability to interpret and present clinical data
Additional qualifications that could help you succeed even further in this role include:
Dental experience in a private, public, government or military environment
Demonstrated experience working on cross-functional teams in a global or regulatory environment
Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU
Excellent attention to detail, time management, and organizational skills
Ability to manage multiple complex projects simultaneously.
Strategic thinking, critical thinking, reasoning, and interpretive skills
Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.
Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency.
Work location: Remote - United States
Travel: May include up to 10% domestic
Relocation Assistance: Not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only:The expected compensation range for this position is $119,076 - $145,537, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
terms.
$119.1k-145.5k yearly Auto-Apply 37d ago
Medical Writers (San Francisco & US Home Based)
Fishawack Group of Companies
Remote medical editor job
Fishawack Group of Companies is a group of dynamic healthcare communications companies that includes US offices in the San Francisco and Philadelphia areas, as well as offices in the UK and Switzerland. Fishawack has a reputation built on excellence and creativity and bound by a common philosophy as well as a commitment to providing premium medical communications services tailored to meet our clients' individual needs. Our hand-picked team has a unique blend of scientific, marketing, and creative expertise with fresh thinking and enthusiasm. We believe that our clients' endorsement is the best testament to the success of our approach.
Job Description
Position Summary
Fishawack has an immediate need for a Medical Writer or Sr. Medical Writer who will work in our San Francisco office, and a Lead Medical Writer who will be home-based (any US location). Both positions require experience in a medical communications or
medical education agency, researching and writing scientific posters, abstracts, manuscripts and presentation materials. These are NOT regulatory medical writer positions.
As part of our Medical Writing & Scientific Services Staff, Medical Writers provide research, writing, and editing expertise for customized medical communications initiatives-scientific posters, abstracts, manuscripts and presentation decks/materials for our pharmaceutical clients. Medical Writers are primarily responsible for developing and delivering original, accurate, high-quality scientific content within the project specifications, timeline, and budget. Our customized initiatives include print, video, and web-based programs. Our Lead Medical Writers function as scientific and therapeutic experts for assigned project teams, and provide high-quality content oversight for both project work and business development efforts. Medical Writers interact regularly with clients and Publication Managers, Project Managers, Review Specialists, Editorial Assistants, faculty, and authors to ensure scientific accuracy, quality, and successful completion of projects.
Main Responsibilities
Research, write, and revise high-quality, original scientific content; develop clear, concise outlines and on-target first drafts, and incorporate data and revisions as needed
Interpret and analyze complex datasets to develop comprehensible scientific content for medical communications initiatives and publications
Cultivate expertise in assigned therapeutic areas
Edit and appropriately reference content written by others; improve the clarity in others' writing and serve as a mentor to junior members of the medical writing team
Represent the company at client meetings (eg, advisory boards, speaker-training meetings) in a professional manner; lead client and internal meetings as necessary
Attend and participate in relevant meetings-based projects (eg, advisory board meetings, symposia, roundtable meetings, congresses, business development meetings) as needed (travel may be required up to 10 times per year)
Effectively and proactively communicate with team members, authors/faculty, clients, and vendors
Qualifications
Advanced degree in the life sciences or related field is required
1-7 years' experience (depending on position level) as a scientific/medical writer in a
medical
communications or medical education
agency setting is required; knowledge of pharmaceutical healthcare marketing principles is preferred
Experience (3-5 years) in developing scientific publications (specifically: posters, abstracts, manuscripts, and presentations) is required; and experience in developing publication plans is preferred
Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel
Proficiency in Internet and PubMed searches
Demonstrated ability to write scientifically focused medical education materials for healthcare professionals with a high degree of grammatical and scientific accuracy and quality
Thorough familiarity with AMA editorial style and medical terminology
Ability to understand the evolving regulatory environment
Ability to work independently with minimal supervision, and as part of a team
Additional Information
All your information will be kept confidential according to EEO guidelines.
Fishawack offers a comprehensive benefits package, which includes generous PTO time; medical, dental, and life insurance coverage that begins on your first day of employment; and a 401(k) retirement plan.
If you are interested in learning more about these full-time opportunities,
please submit your cover letter, resume, and writing samples.
For more information about Fishawack Group of Companies, visit our website at *************************
$89k-135k yearly est. 2d ago
Medical Writer - Clinical Compliance
Healthcare Services 4.1
Remote medical editor job
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
Medical Writer - Clinical Compliance(Solventum)
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
As a Medical Writer - Clinical Compliance you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit.
Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements.
Supporting internal and external audits as a subject matter expert in clinical evaluations.
Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices.
Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND five (5) years of experience in the medical device industry
Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirements
Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes
Strong scientific writing and communication skills, with the ability to interpret and present clinical data
Additional qualifications that could help you succeed even further in this role include:
Dental experience in a private, public, government or military environment
Demonstrated experience working on cross-functional teams in a global or regulatory environment
Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU
Excellent attention to detail, time management, and organizational skills
Ability to manage multiple complex projects simultaneously.
Strategic thinking, critical thinking, reasoning, and interpretive skills
Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.
Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency.
Work location: Remote - United States
Travel: May include up to 10% domestic
Relocation Assistance: Not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only:The expected compensation range for this position is $119,076 - $145,537, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
terms.
$119.1k-145.5k yearly Auto-Apply 37d ago
Associate Medical Writer
Psi Cro Ag
Remote medical editor job
We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Writes, edits, and reviews documents, including informed consent forms, patient information, and other project-specific clinical documentation.
Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives.
Collects and tracks documents for CSR appendices, in support of the Quality Control Associates.
Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates.
Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks.
Collaborates with the Process Improvement narrative automation team to develop patient safety narratives.
Qualifications
College or university degree, preferably a Bachelor's or Master's degree in biomedical or life sciences fields, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years of experience in medical and/or regulatory writing and related tasks.
Minimum 2 years of corresponding industry experience working with clinical documentation and data
Prior pharmaceutical, biotechnology, or contract research organization experience
Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of documents
Basic knowledge of electronic Common Technical Document (eCTD) requirement
Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
$76k-114k yearly est. 2d ago
Principal Medical Writer (Regulatory MW)
Invitrogen Holdings
Remote medical editor job
Principal Medical Writer
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our Medical Writing team is growing, and we are looking for a Principal Medical Writer. This role is based in the United States.
Discover Impactful Work:
Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and Marketing Applications, ensuring outstanding quality and compliance.
A Day in the Life:
Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices.
May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
Keys to Success:
Acts with intensity
Strong project management skills
Excellent interpersonal skills including problem solving and negotiation
Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Education
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Experience in managing and directing complex Regulatory medical writing projects required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
Knowledge, Skills, Abilities
Significant knowledge of global, regional, national and other document development guidelines
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc
Strong project management skills
Excellent interpersonal skills including problem solving and decision-making
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
What We Offer:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
$76k-114k yearly est. Auto-Apply 60d+ ago
Medical Writer
Immunitybio
Remote medical editor job
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.
Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.
Position Summary
The Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator's brochures, and informed consent forms. The Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials.
Essential Functions
Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.
Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.
Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents.
Lead document review meetings and discussions.
Provide direction and solutions to cross-functional teams on expectations for document content.
Perform QC of clinical and nonclinical documents.
Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
Participate in project team meetings.
Performs other duties as assigned.
Education & Experience
A bachelor's degree in science-related fields with 1+ years of experience is required; Or
A master's degree in science-related fields with some experience is required.
1+ year of medical writing experience preferred.
Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions required.
Strong scientific background in oncology, immunotherapy, or related field required.
Knowledge, Skills, & Abilities
Proficient knowledge of AMA writing guidelines.
Excellent verbal and written communication skills in English.
Knowledge of FDA, EMA, and ICH guidelines.
Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously.
Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
Ability to work collaboratively in a dynamic environment.
Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates.
Working Environment / Physical Environment
The position works either onsite in El Segundo, CA; Torrey Pines, CA; or remotely depending on the candidate's geographic location.
Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval
Lift and carry materials weighing up to 20 pounds.
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$100,000 (entry-level qualifications) to $110,000 (highly experienced) annually
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$103,000 (entry-level qualifications) to $113,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
$100k-113k yearly Auto-Apply 60d+ ago
Medical Writer
Artech Information System 4.8
Remote medical editor job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
• Candidate must be team orientated Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
• Responsibilities include preparation of regulatory documents on behalf of Client in accordance with the ICH guidelines, international regulations, Client standards and processes, and the Client Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents.
• Participate in project team meetings to provide input regarding deliverables, timelines, and processes. Responsible for managing the document review process. Route documents for approval. The medical writer should be familiar with ICH guidelines and the current AMA Style Manual. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines
Qualifications
Qualifications and Experience:
Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred. Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 3 days minimum onsite.
Excellent regulatory writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data.
Experience: 5+ years writing experience in the pharmaceutical industry. Please take note this is a FULL time 40 hour work week. We are looking for someone with experience working as a MW for a major Pharma.
Prior experience in oncology is a plus.
The most important requirement is the ability to independently write regulatory documents in collaboration with the various members of study team.
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
$79k-110k yearly est. 60d+ ago
Medical Writer
Real Chemistry
Remote medical editor job
At Real Chemistry, making the world a healthier place isn't just an aspiration-it's our everyday reality. Our drive to transform healthcare is informed by our blend of deep scientific expertise, human-centred creativity, and AI-driven insights, fostering a unique environment where innovation thrives and our people are impact-obsessed. As a global agency, we provide a full suite of services across healthcare communications and marketing to our clients, including top players in the pharmaceutical and biotech industries.
Our #LifeatRealChem culture is rooted in our people-we believe we are best together and are committed to excellence for both our clients and colleagues. Whether you're a seasoned professional or just starting your career, if you share our passion for healthcare and connection, we invite you to explore our opportunities.
Discover your purpose. Embrace innovation. Experience #LifeatRealChem.
Real Chemistry is looking for a Medical Writer to join our growing team!
This is a hybrid role, based in any of our US offices-including New York City, Boston, Chicago, Carmel, or San Francisco-or remotely within the US, depending on team and business needs.
What you'll do:
Develop scientific copy for various deliverables on assigned brands and products
Work independently and collaboratively with medical writers and directors to develop scientifically accurate copy
Understand medical strategy and content objectives for assigned projects and accounts
Proactively check-in with senior medical leads on project deliverables and raise questions as needed
Review current literature for assigned therapeutics areas, including competitor products
Understand and adhere to AMA/client style guidelines as directed
Ensure references are accurate and research additional references or source materials as necessary
Annotate and highlight references for medical review
Manage workflow for assigned projects and meet associated deadlines
Communicate with clients and/or KOLs to present scientific projects for review and feedback
Incorporate and discuss edits requested by clients, KOLs, and/or internal reviewers
Attend and participate in kickoff, status, and other job-related meetings
Collaborate with creative and illustrative team members to make scientific data visually compelling and scientifically accurate
Provide medical guidance to team by maintaining up to date scientific knowledge for assigned brands and products
This position is a perfect fit for you if:
Our Company values -
Best Together, Impact-Obsessed, Excellence Expected, Evolve Always
and
Accountability with an “I”
- really speak to you.
You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We're always evolving.
You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
You are highly organized self-starter, able to work independently and under tight deadlines.
What you should have:
Advanced degree (eg, MD, PhD, PharmD) required
Up to 1 year of previous medical writing experience in a medical communications agency preferred, but not essential
Familiarity with FDA, AMA and other relevant guidelines
Strong scientific foundation with capability to rapidly become familiar with therapeutic areas and therapies
Ability to communicate complex scientific concepts clearly to a wide range of audiences
Ability to work under pressure; meeting deadlines on-time and on-budget
Ability to work in a team and take initiative to provide input to cross-functional team members
Excellent organizational skills and strong attention to detail
Computer literacy (Word, PowerPoint, Excel, reference managers)
Pay Range: $75,000 - $85,000
This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.
#LI-Remote
Real Chemistry is proud to be Great Place to Work certified; check out what our people shared about our culture and workplace on our Great Places to Work Profile here.
We believe we can do our best when feeling our best, which is why we've put together a benefits program designed to give you the support you and your family need at every stage of life. Real Chemistry offers a comprehensive benefit program and perks, tailored to your region. Globally, this includes offices in our key markets with free snacks to keep you running all day long, generous holiday and paid time off, options for private medical, dental, and vison plans, and support in saving for the future. Other perks include mental wellness coaching and support and access to more than 13,000 online classes with LinkedIn Learning. Learn more about our great benefits and perks and search specific offerings in your region at: ******************************
Working with Real HART: Since the pandemic, we have adapted to how our people told us they want to work. We have office locations in cities in the US, UK, and Europe with many employees and clients that serve as hubs where and when they need us. For employees who are within an hour of one of our offices, we expect attendance in the office two days per week, either at a Real Chemistry office or onsite with clients. We are also actively opening new office locations, so if one opens near you, our Real HART policy will apply. We are not looking for attendance for the sake of attendance but believe that the opportunity to coordinate in-office team meetings, 1:1 meetings with managers, taking advantage of on-site learning, and connecting with client partners is a critical to delivering on our purpose of making healthcare what it should be. Outside of these offices, we have regions, where people work remotely but come together quarterly for collaboration, culture and learning opportunities. We call this our Real Hybrid and Regional Teams (Real HART) approach. Real Chemistry believes we are best together - and our workplace strategy fosters connection and collaboration in person - but also supports flexibility for our people.
Real Chemistry is an Equal Opportunity employer. We continually strive to build and sustain an inclusive and equitable work environment where our employees feel empowered to leverage all they bring from their personal lived experience and professional expertise, to make our team the best in the industry. We encourage motivated and qualified applicants to apply without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity/expression, ethnic or national origin, age, physical or mental disability, genetic information, marital information, or any other characteristic protected by federal, state, or local employment discrimination laws where Real Chemistry operates. Should you require accommodations throughout the interview process please let your recruiter know.
*Notice: Real Chemistry and its affiliates' names are being misused by scammers through messaging services, fake websites, and apps. Do not share personal or financial information or make payments to any unverified sources claiming to be connected to Real Chemistry. We are working to stop these unauthorized activities and protect our community. Read more here.
$75k-85k yearly Auto-Apply 17d ago
Medical Writer, Scientific Communications
Vaniam Group 4.0
Remote medical editor job
at Vaniam Group
Medical Writer, Scientific Communications
What You'll Do
The Medical Writer, Scientific Communications is responsible for writing strategically aligned and accurate materials that meet the high-quality standards of Vaniam Group. You will play a supporting role in managing client satisfaction and relationships. In addition, you are responsible for supporting business improvement by meeting personal and departmental goals and objectives effectively and on time.
A Day in the Life
Deliverables
Develop high-quality content for an array of projects, including publications
(eg, abstracts, presentations, and manuscripts), advisory boards, scientific platforms, gap analyses, literature summaries, slide sets, and training materials
Develop materials that are grammatically accurate and audience appropriate
Client Responsibility
Gain an understanding of the treatment landscape and strategic positioning of client products to help produce strategically aligned materials
Assess project needs and challenges; identify and implement solutions to meet productivity, quality, and client goals while maintaining compliance standards
Participate in client meetings and answer questions about projects when necessary
Internal Responsibility
Build strong partnerships with and understand the importance of meeting the needs of internal teams
Demonstrated ability to effectively utilize time to manage duties, communicating proactively when unable to meet timelines
Work on multiple projects concurrently, prioritizing appropriately
Collaborate with team to execute project and meet deadlines
Emerging ability to assess areas for opportunity and improvement
Business Development
Ensures that work is of the highest quality and instills confidence for clients
Begin to think strategically about work and develop an awareness of the work's impact on business strategy
Other duties may be assigned to help drive deliverables within this role.
What You Must Have
Education and Experience
PhD in life sciences, MD, or PharmD
At least 1 year of work experience in an agency, the pharmaceutical industry, or a related scientific or medical writing position. Preference will be given for experience in hematologic or solid tumor oncology
Working knowledge of digital marketing
Skills and Competencies
Commitment to ethical and transparent data dissemination standards
Demonstrated ability to work collaboratively in a dynamic team environment
Excellent interpersonal, organization, verbal, and written communication skills
Excellent quantitative and analytical skills and ability to synthesize complex or diverse information
Excellent problem-solving skills, including the ability to analyze information skillfully, develop alternative solutions, and work well in group problem-solving solutions
Strong attention to detail and listening skills
Ability to meet tight deadlines and have excellent time management skills
Highly proficient with the following: MS Office (Word, Excel, PowerPoint, Outlook), Adobe, Google or similar calendar system, familiarity with EndNote, and Zoom (or other similar systems) preferred
What You Might Have, but Isn't Required
At least 1 year of experience as an oncology (solid tumors and/or hematologic malignancies) medical writer
Familiarity with EndNote or other reference management software and publication database (ie, DataVision)
Proficient in PubMed or other scientific/medical search websites
Travel Requirements
Travel within the US and internationally as necessary, based on project, sponsor, and organizational needs (
The Team You'll Work Closest With
You will work closely with the Scientific Communications team and partner with the Client Services, Editorial, and Creative departments depending on the project need.
Why You'll Love Us:
100% remote environment with opportunities for local meet-ups
Positive, diverse, and supportive culture
Passionate about serving clients focused on Cancer and Blood diseases
Investment in you with opportunities for professional growth and personal development through Vaniam Group University
Health benefits - medical, dental, vision
Generous parental leave benefit
Focused on your financial future with a 401(k) Plan and company match
Work-Life Balance and Flexibility
Flexible Time Off policy for rest and relaxation
Volunteer Time Off for community involvement
Emphasis on Personal Wellness
Virtual workout classes
Discounts on tickets, events, hotels, child care, groceries, etc.
Employee Assistance Programs
Salary offers are based upon several factors including experience, education, skills, training, demonstrated qualifications, location, and organizational need. The range for this role is $70,000 - $85,000. Salary is one component of the total earnings and rewards package offered.
About Us: Vaniam Group is a people-first, purpose-driven, independent network of healthcare and scientific communications agencies committed to helping biopharmaceutical companies realize the full potential of their compounds in the oncology and hematology marketplace. Founded in 2007 as a virtual-by-design organization, Vaniam Group harnesses the talents and expertise of team members around the world. For more information, visit ******************** Applicants have rights under Federal Employment Laws to the following resources:
Family & Medical Leave Act (FMLA) poster - *********************************************
EEOC Know Your Rights poster - ***************************
Employee Polygraph Protection Act (EPPA) poster - **************************************************************************
$70k-85k yearly Auto-Apply 60d+ ago
Editors - AI Trainer (Contract)
Handshake 3.9
Remote medical editor job
Handshake is recruiting Editor Professionals to contribute to an hourly, temporary AI research project-but there's no AI experience needed. In this program, you'll leverage your professional experience to evaluate what AI models produce in your field, assess content related to your field of work, and deliver clear, structured feedback that strengthens the model's understanding of your workplace tasks and language. The Handshake AI opportunity runs year-round, with project opportunities opening periodically across different areas of expertise.
Details
The position is remote and asynchronous; work independently from wherever you are.
The hours are flexible, with no minimum commitment, but most average 5-20 hrs
The work includes developing prompts for AI models that reflect your field, and then evaluating responses.
You'll learn new skills and contribute to how AI is used in your field
Your placement into a project will be dependent on project availability-if you apply now and can't work on this project, more will be available soon.
Qualifications
You have at least 4 years of professional experience in one or more of the following types of work.
The examples below reflect the types of real-world responsibilities that you might have had in your role that will give you the context needed to evaluate and train high-quality AI models
Edit and proofread content to correct errors and enhance readability, while verifying facts and statistics.
Collaborate with authors on content revisions and oversee publication production, ensuring adherence to deadlines and budgets.
Develop content ideas and manage editorial staff, coordinating with various departments to resolve issues and maintain publication standards.
You're able to participate in asynchronous work in partnership with leading AI labs.
Your real-world expertise will help train AI tools designed to upskill-not replace-the next generation of skilled trade workers.
Application Process
Create a Handshake account
Upload your resume and verify your identity
Get matched and onboarded into relevant projects
Start working and earning
Work authorization information
F-1 students who are eligible for CPT or OPT may be eligible for projects on Handshake AI. Work with your Designated School Official to determine your eligibility. If your school requires a CPT course, Handshake AI may not meet your school's requirements. STEM OPT is not supported.
See our Help Center article
for more information on what types of work authorizations are supported on Handshake AI.
#indhp
$37k-60k yearly est. Auto-Apply 15d ago
Geography Course Editor (Contract)
Study.com 3.9
Remote medical editor job
Geography Course Editor Course Editors play a crucial role in ensuring the quality of our credit-recommended college courses. This project aims to enhance and update college-level courses to ensure they meet current academic standards and industry requirements. This is an online, remote contract role. All work is paid per hour. Project Description You will review and edit existing college-level course structure and materials in your subject area. This is expected to include tasks such as (but not limited to):
Evaluating and adjusting recommended updates to existing course structure
Reviewing course learning outcomes and competencies for accuracy and alignment
Editing skill-oriented course sections and ensuring proper organization
Reviewing and refining response assignment prompts and rubrics
Evaluating existing multiple choice questions for quality and accuracy
Required Skills:
Master's degree or higher in Geography
Experience teaching courses in a college or university setting
Experience creating, updating or revising courses at a college or university level
Additional Preferred Skills:
Strong time management skills to meet due dates
Receptiveness to feedback and willingness to revise submitted work as needed
Ability to collaborate with curriculum designers to create high-quality course deliverables
What We Offer:
Reliable Payments: You'll receive payments twice a month and automated invoicing for your work.
Remote Work: This is a fully online contracted work-from-home opportunity.
Flexibility: Basically, there are no requirements! Work when you want, where you want, as often as you want, with no minimums/maximums.
Support: Our supportive staff is available answer your questions and help you get up and running.
The Contract Process
Complete the application and submit with your resume.
Applications are approved and contracts sent on Wednesdays.
Submit the contract within the 5-day signing window.
The following Wednesday, you'll receive onboarding instructions.
You can view a step-by-step overview of the contract process here: How to Become a Freelancer with Study.com
About Study.com
The mission of Study.com is to make education accessible, and over the last two decades we've become the leading online education platform, delivering a personalized learning experience across a broad continuum of education for over 30 million students, instructors, and professionals every month.
We help empower millions of learners to achieve their education and career goals. We focus on increasing access to education because we know information is the ultimate equalizer and that education is key to upward mobility.
Feel free to share this opportunity with any friends you think would be interested, too.
$37k-61k yearly est. Auto-Apply 30d ago
Editor
Spotify
Remote medical editor job
We are looking for an experienced Editor for Western Europe region (Belgium, France Luxembourg), to join Spotify's Music Editorial team based in Paris. In this role you will be part of the Music team in the Western Europe region You will contribute your expertise to various music-related projects within the company, including playlist curation, creative editorial work, and cross-functional collaboration with different teams in the region and beyond. You will provide deep cultural and musical insights to build highly engaging and cohesive music experiences for listeners, extending beyond playlists, while ensuring an unbiased editorial voice for a wide array of moods, moments, and genres. Additionally, you will drive artist discovery through an extensive editorial ecosystem of playlists and tools, critically assessing music trends and user behaviour to identify opportunities and emerging trends.
You will demonstrate a team player spirit, a passion for performance-oriented analytics, and a solid understanding of Spotify's role in the music industry both locally and globally. Additionally, you will have an editorial personality that thrives in engaging audiences through creative formats, bringing the playlists to life in innovative ways.
As a music editor, you will be encouraged to make data-informed decisions while also contributing creative and cultural expertise. Above all, your work will impact the way the world experiences music!
What You'll Do
* Listen to music from a wide range of musical genres and proactively identify music trends, emerging talent, and opportunities in the local and global music landscape, acting as a cultural guide.
* Curate cohesive, engaging playlists for Belgium and France with compelling descriptions and commentary that resonate with audiences.
* Analyze user behavior and performance data to optimize playlist engagement and make informed editorial decisions.
* Collaborate with global and regional editorial teams on programming initiatives and strategies to improve Spotify's market position.
* Work cross-functionally with teams like marketing, develop, and product to achieve strategic goals and integrate cultural insights into workflows.
* Support artist discovery and help grow fan bases for artists in Belgium and France through editorial projects and internal workflows.
* Occasionally participate in creative and innovative formats to bring playlists to life and develop a deeper connection with listeners.
Who You Are
* You are proficient in written and spoken French and English. Flemish and/or Dutch as a plus
* You have at least 5 years of music industry experience in the music industry, journalism, programming/curating music for digital, radio, TV, or other media outlets.
* You are dedicated to music every day and have deep knowledge of music, artists and culture, with a focus on Belgian and French-speaking markets
* You have a broad expertise across all genres and styles - from Hip-Hop to Pop, Indie to French Variety or Dance to Rock - and can curate music for diverse moods and moments.
* You are skilled in interpreting data and analytics to inform editorial decisions and optimize performance.
* You are culturally aware, with the ability to critically evaluate movements, and audience behavior beyond just data.
* You are knowledgeable of Google Suite tools, comfortable with basic design tools and workflows, capable of creating visual assets like playlist covers when necessary.
* You are an excellent communicator, capable of connecting with audiences through written, video, or audio commentary to improve playlists.
* You're a standout colleague who is organized, meticulous, adaptable to change, and consistently demonstrates a positive attitude.
Where You'll Be
* You'll be based out of our Paris, France office.
* We offer you the flexibility to work where you work best! There will be some in-person meetings, but still allows for flexibility to work from home.
Spotify is an equal opportunity employer. You are welcome at Spotify for who you are, no matter where you come from, what you look like, or what's playing in your headphones. Our platform is for everyone, and so is our workplace. The more voices we have represented and amplified in our business, the more we will all thrive, contribute, and be forward-thinking! So bring us your personal experience, your perspectives, and your background. It's in our differences that we will find the power to keep revolutionizing the way the world listens. Spotify transformed music listening forever when we launched in 2008. Our mission is to unlock the potential of human creativity by giving a million creative artists the opportunity to live off their art and billions of fans the chance to enjoy and be passionate about these creators. Everything we do is driven by our love for music and podcasting. Today, we are the world's most popular audio streaming subscription service.
Spotify is an equal opportunity employer. You are welcome at Spotify for who you are, no matter where you come from, what you look like, or what's playing in your headphones. Our platform is for everyone, and so is our workplace. The more voices we have represented and amplified in our business, the more we will all thrive, contribute, and be forward-thinking! So bring us your personal experience, your perspectives, and your background. It's in our differences that we will find the power to keep revolutionizing the way the world listens.
Spotify transformed music listening forever when we launched in 2008. Our mission is to unlock the potential of human creativity by giving a million creative artists the opportunity to live off their art and billions of fans the chance to enjoy and be passionate about these creators. Everything we do is driven by our love for music and podcasting. Today, we are the world's most popular audio streaming subscription service.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Find our AI notice here: ***********************************
$31k-48k yearly est. 14d ago
Medical Writer, Clinical Development
Axsome Therapeutics 3.6
Remote medical editor job
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X.
About This Role
Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
Interpret, analyze, and synthesize complex clinical data and develop high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs
Attend strategic meetings as applicable
Closely collaborate with, and apply strategic direction from, project leads and biostatisticians to manage and prioritize assignments and ensure deliverables are completed per time and quality goals
Develop documents for assigned programs in compliance with company standard operating procedures (SOPs)
Participate in developing timelines, managing review/approval workflows, and QC/publication readiness
Lead cross-functional teams to ensure team-wide agreement on documents content
Oversee outsourced medical writings projects and the associated vendor(s), as applicable
Ensure compliance and accountability for all regulatory documents prepared by the company
Requirements / Qualifications
Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years of relevant experience
Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Document
A strong working knowledge of pharmaceutical drug development and GxP principles
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Experience, Knowledge and Skills
Highly knowledgeable in psychiatric and/or neurological disease areas is a plus
Track record of developing high-quality scientific documents
Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents
Familiarity with the preparation of Statistical Analysis Plans and document data mapping
Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data
Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables
Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership and maintaining the security of proprietary information
Ability to manage/prioritize multiple projects under general supervision while working in a fast-paced environment
Flexibility for adapting to rapidly changing deadlines and priorities
Must be extremely detail oriented
Able to self-manage effort to maintain alignment with strategy and corporate goals
Salary & Benefits
The anticipated salary range for this role is $140,000 - $175,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.