Medical Science Liaison, Mid-Atlantic Region (PA, NJ, DE, MD, DC, WV, VA)
Danone 4.8
Medical writer job in Pennsylvania
United States
Rockville,Philadelphia
Remote
USD 120000.00-130000.00
Permanent Full-Time
About the job
The Medical Science Liaison, will be responsible for providing medical opinion to Medical Affairs on matters relevant to infants, children, adolescents and adults with medical conditions related to gastroenterology, food allergies, and challenged growth as well as other related conditions. The Medical Science Liaison provides the medical bridge between clinical research and Medical Department, as well as remaining departments within the organization. The position will leverage knowledge of science and clinical practice to develop credible initiatives aligned with Faltering Growth and any other identified category objectives to drive business. Person will work closely with a cross‑functional team including Marketing, Sales Regulatory/Legal and, Cross-functional work involves ability to develop strategies to drive business, including successful product launches, messaging and identifying new areas of business. The position requires working closely with major stakeholders, including key medical opinion leaders. This role will work closely with HCPs to conduct real world evidence programs. Person is responsible for assuring medical messaging on products and product uses align with corporate goals. This position requires development of health care education materials, and training to internal and external stakeholders. Role requires ability to submit abstracts to present at national/international professional conferences.
Candidate must be based in the Mid-Atlantic region which will encompass Pennsylvania, New Jersey, Delaware, Maryland, DC, West Virginia, and Virginia.
Essential Functions:
Identify, cultivate, and maintain interactive relationships with current and future Key Opinion Leaders, Study Investigators, and professional organizations. Work with N+1 on developing strategies for driving regional business initiatives.
Manage local/regional projects on new business initiatives.
Active participation in driving successful launching of either new products in current areas of business or current products in new medical initiatives.
Leverage relationship with KOLs to understand the role and current use of Nutricia products and gain consensus on optimal ways to include products in clinical practice.
Consult KOLs, where appropriate, to ensure that medical messaging is scientifically and medically sound.
Provide competitive intelligence to internal stakeholders to gain public insights on competitor activities.
Work with N+1 on developing and conducting a strong evidence generation platform, including Early Experience Programs.
Provide support and in‑house medical training to salesforce, and to participate in 1:1 visits, meetings and speaker programs.
Manage KOL/ speaker bureau-delivered peer‑to‑peer educational talks in key area of business.
Reach out and develop relationships with top and midtier KOLs to drive awareness, recommendation and prescriptions.
Investigate new products ideas and emerging trends in nutrition therapy.
Facilitate clinical trial management on clinical research.
Provide training and support to Sales Force.
Actively participate with sales team one‑on‑one clinical visits, meetings, speaker programs, seminars, etc. Co‑manage peer‑to‑peer programs with sales force.
Provide medical, scientific and technical expertise as part of the innovation process.
Participate in medical/educational programs and initiatives, advisory boards, data presentation to key physicians, speaker training and research initiatives.
Support publications and medical communications activities.
Support commercial team with medical and scientific expertise.
The base compensation range for this position is $120,000 - $130,000 commensurate with experience. Danone North America additionally offers a performance‑based bonus and has a strong benefits package including Medical, Dental, Vision, Prescription Drug Coverage, 401k Plan, Wellness Program, Life Insurance, Tuition Reimbursement, Flexible Time Off, and Paid Parental Bonding Leave, among other benefit plan options.
About you
Knowledge and Skills:
Keep current on market trends, medical and nutrition practices.
Experience in HCP learning strategies for education and training.
Manage projects for successful completion.
Ability to both provide and receive constructive feedback.
Build and maintain strong relationships with colleagues and key external stakeholders.
Work style - strong team player. Work as part of a team to reach common goals. Proven ability to work independently.
Supervisory responsibilities:
The Medical Science Liaison does not have direct reports.
Working conditions:
Work is conducted in a hybrid model. Up to 60% domestic travel is required.
5 years' experience in nutrition, including clinical work, industry or other fieldwork in area of nutrition.
Registered Dietitian with advanced scientific and/or medical training such as PhD, DCN, RD‑AP, MS, or CNSC. NP, RN, Pharm D, or RD's with relevant therapeutic area experience will also be considered.
Must reside in the Mid-Atlantic region which will encompass Pennsylvania, New Jersey, Delaware, Maryland, DC, West Virginia, and Virginia.
Preferred:
Faltering growth, GI, cardiac, pediatric intensive care units, or nutritional product experience desirable.
Success factors:
Self‑motivated
Deliver creative ideas for change and continuous process improvement
Excellent organizational skills
Excellent presentation skills
Knowledge in basic Microsoft Office, including PowerPoint, Excel and Word, EndNote
Ability to manage projects through successful completion
Self‑directed
Time management; ability to prioritize work and time to complete products on time
About Danone
Life at Danone
With approximately 5,000 employees and 13 production locations across the U.S., our vibrant culture and endless growth opportunities are just a couple of the reasons our employees call themselves "Proud Danoners."
Our Purpose
We're committed to making a positive impact on our world. Rooted in our mission to bring health through food to as many people as possible, we're proud to be the world's largest B Corp.
Our Benefits
Our commitment to making the world healthier starts with our employees.
Physical Wellbeing: We pay for the majority of your medical benefits - which include medical, dental and vision - with our competitive 80%/20% cost‑sharing model
Mental Wellbeing: Danoners receive fitness discounts, unlimited flexible time off and hybrid work schedules. We also have a range of programs that support mental health and substance abuse.
Financial Support: We offer a performance‑based bonus, a 401(k) plan, tuition reimbursement, employee discount programs and voluntary perks.
Family Care: We offer caretaker benefits, 18 weeks of parental bonding, fertility, surrogacy, adoption benefits and pet insurance.
Equal Opportunity Employer
Danone North America is proud to be an Equal Opportunity employer. It is our policy to give equal employment opportunities to all qualified persons without regard to legally protected characteristics, or any other consideration made unlawful by applicable federal, state/provincial and/or local law. For our EEO policy statement and your EEO rights under law click here .
Dedicated to bringing health through food to as many people as possible, we are a leading global food & beverage company built on four businesses: Essential Dairy and Plant‑Based Products, Waters, Early Life Nutrition and Medical Nutrition.
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$120k-130k yearly 4d ago
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Assistant Editorial Director - Psych & Neuroscience
HMP Global 4.1
Medical writer job in Malvern, PA
Reports To: President, HMP Global
Direct Reports: Managing Editor and Associate Editor
Location: Hybrid (3 days in-office/2 days work-from-home in either Malvern, PA or East Windsor, NJ) or Remote (depending on your proximity to our offices)
Travel: Up to 5 trips/year to proprietary HMP events (no external industry events)
Benefits: Medical, Dental, Vision, 401k w/discretionary match, PTO, Life Insurance
Eligible for annual discretionary bonus
HMP is a leading healthcare event and education company, with a dominant position in several therapeutic areas including Oncology, Psychiatry & Behavioral Health, Cardiovascular, Wound Care and Public Safety. With a mission to improve patient care, we deliver information and education to healthcare professionals through 400+ global, regional, and local events and reach over 4 million users monthly through digital networks and social channels.
Position Summary
HMP Global seeks a highly organized and strategic Assistant Editorial Director to lead and optimize content operations for the Psych Congress Network (PCN) and NP Institute Online Learning Hub. This role oversees daily content development and deployment, manages advisory board and key opinion leader relationships, supervises an editorial team, and drives editorial and digital strategy and brand alignment across multiple content channels.
This position has limited writing responsibilities but requires expertise in content development, editing, content management, stakeholder engagement, and cross-functional collaboration with education, marketing, and multimedia teams.
Functional Focus Breakdown
Content Development and Management: 40%
Key Opinion Leader Engagement (Advisory Board & Onsite): 30%
Editing: 30%
Writing: Minimal
Content Management & Development
Manage and participate in digital content development and execution across the Psych Congress Network and the NP Institute Online Learning Hub brand channels.
Work with executive management to plan the content of the strategic vision, including short- and long-term goals with SOPs, to ensure successful strategic execution.
Establish, maintain, and nurture relationships with key experts in psychiatry and neurology.
Ensure the editorial and clinical missions are reflected in all content produced by the team.
Identify, create, and lead approved new content initiatives to increase brand awareness and improve engagement.
Work with the content team and digital operations to fulfill sponsored campaigns.
Develop original brand house and campaign content, including newsletters.
Oversee social media plan execution and monitor ROI.
Analyze content metrics to drive decision-making.
Attend relevant internal and approved external conferences for content and networking.
Support ongoing content tagging initiatives aligned with corporate goals.
Ensure effective and appropriate use of AI tools across brands.
Departmental Collaboration
Collaborate with the Psych Congress Education Team on content and business opportunities across brand channels.
Work on independent content projects with meeting Chairs, Steering Committees, and Faculty.
Collaborate with The Collective (HMP internal agency) to maximize reach and engagement.
Partner with other brand managers to enhance cross-division content opportunities.
Work with Sales, Design, and Marketing counterparts to meet content/business objectives.
Support executive initiatives aimed at improving team workflows and strategic impact.
External Associations
Explore and maintain approved partnerships with leading organizations and academic centers.
Monitor industry trends and drug development to ensure relevant content coverage.
Engage with contributors and faculty to identify topics and monitor trends.
Team Management
Lead assigned teams as a role model committed to business goals and professional development.
Ensure completion of all mandatory management training.
Track and manage team content deadlines.
Oversee digital execution and e-newsletter deployments across platforms.
Ensure consistent content tagging by the team.
Implement and maintain written SOPs for key editorial processes.
Conduct weekly team and 1:1 meetings to track brand status and development goals.
Identify networking and growth opportunities for the team.
Train, evaluate, and support staff while prioritizing workflows.
Foster a positive team atmosphere focused on motivation and performance.
Provide formal performance reviews and oversee evaluation processes.
Ensure editorial adherence to internal and AMA style guidelines.
Required Qualifications
10+ years of relevant editorial/content experience, ideally in psychiatry, neurology, or clinical media.
Strong background in digital content execution, KOL engagement, and campaign-focused editorial strategy.
Ability to manage daily content volume, multimedia workflows, and cross-departmental projects.
Exceptional editing skills and familiarity with AMA style.
Experience managing direct reports and fostering team development.
Preferred Qualifications
A graduate degree is preferred: Master's, PhD, PharmD, or MD in life sciences, communications, or healthcare.
Familiarity with:
- Newsletter tools (e.g., Ongage, HubSpot)
- Multimedia content production (video/podcast)
- Campaign analytics and performance tracking
- AI tools like ChatGPT for professional editorial use
Please follow HMP Global on LinkedIn for news and updates
$64k-86k yearly est. 4d ago
Editor in Chief / Deputy Editor ( Immunology)
Wiley Publishing
Medical writer job in Hoboken, NJ
**:**Editor in Chief / Deputy Editor ( Immunology)**Location:**Beijing, CHNOur mission is to unlock human potential. We welcome you for who you are, the background you bring, and we embrace individuals who get excited about learning. Bring your experiences, your perspectives, and your passion; it's in our differences that we empower the way the world learns.**About the Role:****About the Role:**We are seeking a highly motivated and strategic Editor-in-Chief/Deputy Editor to join Wiley's Advanced team, serving as Deputy Editor [Immunology] for our flagship journal, *Advanced Science*, and Editor-in-Chief of a related Advanced spin-off title. The ideal candidate will be a dedicated Advanced portfolio ambassador with an extensive global network in immunology and translational research, driving strategic initiatives that bridge groundbreaking research communities and shape how interdisciplinary science is published and shared worldwide. The Editor-in-Chief/Deputy Editor actively participates in the peer review process and decision-making for submitted manuscripts while ensuring adoption of best practices and the highest ethical standards in publishing.**How you will make an impact:*** Develop and execute strategic initiatives to grow Wiley's Advanced Portfolio within immunology globally.* Commission high-quality papers and build collaborative relationships with leading researchers through community engagement to enhance content quality and brand influence.* Collaborate with the global editorial team to manage manuscripts submitted from related subject areas for *Advanced Science.** Launch and oversee management of new Advanced spin-off titles in relevant subject areas as the brand expands.* Manage titles within a team of in-house editors and involved in immunology cluster strategy* Collaborate closely with marketing teams to devise and implement brand-enhancing events and initiatives for both short-term and long-term success.* Lead generation and ideas for subject-related products passed on to appropriate colleagues**What we look for:*** PhD in Immunology related areas. Post-doctoral and clinical experience would be preferred.* Manuscript handling experience (prescreening, peer review, final decision, appeals and integrity cases).* Subject-Matter Expertise (academic).* Strong global network within research communities and proven track record of engaging with top-tier research talents.* Displays high integrity and honesty.* Mindset with ability to identify opportunities and convert strategic visions into actionable plans.* Excellent communication and relationship-building skills with both internal and external stakeholders.* Love to travel (internationally).***More about the Job Description:****The Editor-in-Chief/Deputy Editor is entrusted with the strategic development and execution of initiatives aimed at growing Wiley's Advanced Portfolio within the disciplines of Immunology and related Life and Health Science disciplines. With an extensive global network, the Editor-in-Chief/Deputy Editor serves as a dedicated ambassador and advocate for Wiley's Advanced Portfolio in the immunology research community.**This role is pivotal for the advancement and expansion of a critically important brand, ensuring alignment with and achievement of the company's strategic goals and objectives. The Editor-in-Chief/Deputy Editor is tasked with converting strategic visions into actionable plans, identifying and seizing opportunities to meet the targets set for Research Publishing. In close collaboration with the marketing team, they will devise and implement a range of brand-enhancing events and initiatives aimed at both short-term and long-term success.**The Editor-in-Chief/Deputy Editor will concentrate on enriching the content and elevating the brand profile of Advanced Science, effectively directing excess submissions to relevant clusters within Wiley's Life and Health Sciences portfolio. Additionally, the Editor-in-Chief/Deputy Editor will launch one or more new spin off titles in the relevant subjects and oversee the management of the Advanced spin off titles.**By actively engaging with research communities, the Editor-in-Chief/Deputy Editor is committed to commissioning high-quality papers, extending the brand's influence, and forging positive, collaborative relationships with leading researchers. They approach their work with an understanding of the needs of both external and internal stakeholders, driving forward initiatives that connect with top-tier research talents.**The Editor-in-Chief/Deputy Editor will provide regular updates to the Senior Manager on community engagement efforts and journal development progress. These reports will include evidence of the impact made by the Immunology initiatives and demonstrate the successful delivery of strategic goals for Wiley's Advanced Portfolio. They will also outline programs and strategies designed to attract and retain authors, as well as to enhance the growth of high-quality content within Advanced Science, across the Advanced portfolio, and the related subject clusters.***About Wiley:**Wiley is a trusted leader in research and learning, our pioneering solutions and services are paving the way for knowledge seekers as they work to solve the world's most important challenges. We are advocates of advancement, empowering knowledge-seekers to transform today's biggest obstacles into tomorrow's brightest opportunities. With over 200 years of experience in publishing, we continue to evolve knowledge seekers' steps into strides, illuminating their path forward to personal, educational, and professional success at every stage. Around the globe, we break down barriers for innovators, empowering them to advance discoveries in their fields, adapt their workforces, and shape minds. Wiley is an equal opportunity/affirmative action employer. We evaluate all qualified applicants and treat all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, genetic information, or based on any individual's status in any group or class protected by applicable federal, state or local laws. Wiley is also committed to providing reasonable accommodation to applicants and employees with disabilities. Applicants who require accommodation to participate in the job application process may contact ******************* for assistance. We are proud that our workplace promotes continual learning and internal mobility. Our values support courageous teammates, needle movers, and learning champions all while striving to support the health and well-being of all employees. We offer meeting-free Friday afternoons allowing more time for heads down work and professional development, and through a robust body of employee programing we facilitate a wide range of opportunities to foster community, learn, and grow. We are committed to fair, transparent pay, and we strive to provide competitive compensation in addition to a comprehensive benefits package. It is anticipated that most qualified candidates will fall within the range, however the ultimate salary offered for this role may be higher or lower and will be set based on a variety of non-discriminatory factors, including but not limited to, geographic location, skills, and competencies. Wiley proactively displays target base pay range for United Kingdom, Canada and USA based roles. When applying, please attach your resume/CV to be considered.#LI-YZ1### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
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$48k-77k yearly est. 3d ago
Technical Writer
Rajant Corporation 4.4
Medical writer job in Malvern, PA
Technical Writer - Wireless Networking Products
RAJANT CORPORATION, the 20+-year leader in industrial wireless patented Kinetic Mesh networking solutions, providing full mobility and autonomous products, is seeking a Technical Writer.
Are you passionate about turning complex technical ideas into clear, useful content? We are looking for a Technical Writer to craft exceptional user manuals, data sheets, and documentation for our cutting-edge communication technologies.
Join our small, collaborative team to drive real-world results in industries like mining, military, and telecom to support our global customers.
About the Role:
As a Technical Writer for Rajant, you will work within a group of writers to deliver content for new product releases and updates. You create and curate content that helps our diverse, global audience understand and use our software and hardware products. You also help define internal processes, maintain overall content standards, and drive the evolution of our technical content for customer audiences and end users.
To succeed in this role, you must be naturally curious and collaborative, and enjoy clearly explaining complex technologies across a large product suite. You are able to deliver consistently with management supervision and guidance as part of a collegial and supportive team.
🔧 Responsibilities
Assist in preparing and maintaining user guides, product manuals, specification sheets, and technical publications
Gather technical information and prepare written text
Interview subject matter experts and create content appropriate for the target audience
Work with desktop publishing tools, image editing software, and document design applications
Participate in agile activities (daily standup, sprint planning, and sprint review) to track and share project status
Review and copyedit fellow writers' content to promote consistency and quality, and ensure documentation meets standards and guidelines
Collaborate with other departments and stakeholders to ensure proper documentation approval prior to release
Contribute to and support multistage documentation projects with assistance from managers and peer writers
✅ Requirements:
Bachelor's degree and minimum two years' experience as a Technical Writer (or related course work)
Excellent written and verbal communication skills
Proficiency in English grammar and writing principles
Proven track record of contributing to documentation projects from inception through delivery
Assist with managing writing projects through multiple milestones, and manage more than one project at a time
Proactive mindset, taking initiative to root out and assimilate information and formulate next steps toward delivery
Strong curiosity and desire to learn about technology
Ability to install and operate software products with assistance
High attention to detail with a strong focus on content accuracy and quality
Ability to build relationships that provide ongoing access to information
Ability to understand basic editing concepts and write technical copies for various types of documents for a program/project of similar complexity
🌟 Desirable Skills and Experience:
A problem-solving and continuous improvement mindset
Writing content for software and hardware products
Exposure to working within an agile development methodology
Ability to perform Git operations including branching, repository management, pull requests, and resolving merge conflicts
Familiarity with writing in Markdown
Experience using desktop publishing tools, such as Adobe InDesign
Experience using image editing software, such as Adobe Photoshop
💡 Why Rajant?
You'll be documenting real-world technologies that empower defense, mining, energy, and critical infrastructure sectors. You'll join a forward-thinking company where your writing will make a real impact on global industries.
Professional growth: Opportunity to work with cutting-edge Kinetic Mesh networking technology. We invest in our team's development through on-the-job training and chances to take on new responsibilities as you grow.
Collaborative culture: Be part of an award-winning workplace with a tight-knit team of engineers and innovators. We pride ourselves on a fun, inclusive environment where your contributions matter. (Rajant has been recognized as a Best Place to Work in Pennsylvania & Kentucky.)
Rajant's Company Profile: **************
We are the biggest name in dynamic wireless mesh networking you may not have heard of yet. No other mesh solution even comes close to the performance of our patented InstaMesh Kinetic Mesh technology in dynamic environments.
We drive massive mines all over the globe, enabling autonomous haul trucks, shovels, and other equipment.
Our networks are in factories and warehouses automating repetitive and dangerous tasks.
We're in 'Spot' the Robot Dog and in a variety of aerial drones.
We link Oil and Gas sites, and automate Maritime Ports worldwide.
The U.S. Army trusts our resilient mesh technologies to keep America and our Global partners safe.
Who We Are: We're a tight-knit group of technology experts that demand excellence of ourselves and in all we do. We need like-minded professionals to identify tech problems and solve them, enabling our development teams to efficiently push ever more hardware and software solutions to market, faster and more reliably.
📬 Ready to Apply?
Do you have what it takes to be a part of the Rajant Team? Impress us with your resume today. If you make the team, this will be the most challenging and rewarding place you'll ever work.
Send us your resume and a portfolio of writing samples to **********************. We're excited to see how you can help shape the voice of Rajant's innovative solutions.
Job Details: Full-Time, annual salary with Full Benefits. Location: Rajant Corporate Office in Malvern, PA.
Job Details: Full-Time, annual salary with Full Benefits.
Location: Rajant Corporate Office in Malvern, PA.
Apply: EASY APPLY or introduce yourself w/ cover letter & resume to: **********************.
Rajant Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, national origin, age, physical or mental impairment, sexual orientation or any other category protected under federal, state or local law. Rajant is a USG Contractor and complies with all US laws, regulations and Executive Orders.
$45k-60k yearly est. 2d ago
Medical Writer I, II or III
Mitsubishi Tanabe Pharma America 4.1
Medical writer job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
As a key member of our Clinical Development Team, the MedicalWriter will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include substantive editing and review, researching and obtaining published reports on studies in a variety of different indications, writing executive summaries, and coordinating the publication of key preclinical and clinical scientific data through peer-reviewed journals and forums.
Job Description
Researches, writes and edits pre-clinical and clinical reports, summarizing data from pre-clinical
and clinical studies.
Prepares clinical reports, summary documents, investigator's brochures, package inserts, protocols and protocol amendments, and other documents that may be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for publication and/or presentation.
Works collaboratively, contributing to cross-functional teams and projects.
Develops and drives detailed project timelines according to team-specified deadlines.
Assists in the development of formats and guidelines for clinical documentation.
May prepare scientific manuscripts, abstracts and posters.
May also support clinical research associates and medical doctors in clinical protocol
development.
Proactively keeps abreast of professional information, trends and technology through conferences,
networking and other information sources and brings forward innovative ideas for consideration.
Perform other duties as assigned.
Qualifications
BA/BS required; preferably in a related scientific discipline.
Advanced scientific degree (MS, Pharm D, PhD) is preferred.
2-8 years of well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA-required regulatory documentation (e.g., pharmacokinetic and toxicology summaries and investigator brochures).
Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences.
Expertise in clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH) and GCP. Ability to quickly develop an understanding of company SOPs.
Outstanding interpersonal skills and the ability to work within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed.
Strong project management skills; ability to multitask while driving towards critical deadlines on all
projects.
Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
Excellent written/oral communication skills. Good interpersonal skills;
able to establish rapport with all functional leaders, experts and colleagues
.
Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with
current electronic authoring, document management and electronic regulatory submissions.
Willingness to travel, though travel is likely infrequent.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.
At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
$77k-110k yearly est. 1d ago
Medical Writer
Systimmune, Inc.
Medical writer job in Princeton, NJ
The medicalwriter will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure.
Key Responsibilities:
* Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
* Act as a member of clinical trial teams
* Follow and track clinical documentation milestones
* Write/edit other strategic documents, as required
Required Qualifications:
* Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medicalwriter in the pharmaceutical industry PhD with at least 1 year experience as a medicalwriter in the pharmaceutical industry
* Excellent writing and effective communication skills
* Proven interpersonal, organizational and problem-solving skills in a matrix management environment.
* Knowledge of FDA and ICH guidelines
* Skilled in clinical data interpretation
* Proven experience writing/supporting major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)
Preferred Qualifications:
* Knowledge of drug development and regulatory requirements to guide document organization
* Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality
The hiring pay range for this position is $80,000 - $130,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$80k-130k yearly 46d ago
Medical Writer
Systimmune
Medical writer job in Princeton, NJ
The medicalwriter will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure.
Key Responsibilities:
Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
Act as a member of clinical trial teams
Follow and track clinical documentation milestones
Write/edit other strategic documents, as required
Required Qualifications:
Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medicalwriter in the pharmaceutical industry PhD with at least 1 year experience as a medicalwriter in the pharmaceutical industry
Excellent writing and effective communication skills
Proven interpersonal, organizational and problem-solving skills in a matrix management environment.
Knowledge of FDA and ICH guidelines
Skilled in clinical data interpretation
Proven experience writing/supporting major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)
Preferred Qualifications:
Knowledge of drug development and regulatory requirements to guide document organization
Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality
The hiring pay range for this position is $80,000 - $130,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$80k-130k yearly Auto-Apply 46d ago
Associate Medical Writer
Bioclinica
Medical writer job in Princeton, NJ
Bioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network-and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations
Job Description
The MedicalWriter will be responsible for the creation and development of all study start-up documents such as the Site Manual and associated forms, as well any required Protocol Amendment Impact forms and Compliance Reports for the life of each study. The MedicalWriter is also expected to provide guidance and support to the Clinical Project Management Team, including the review of Project-Specific Work Instructions and attending document-related Sponsor calls.
Primary Responsibilities
Performs study start up responsibilities by:
Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels
Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries
Creating, modifying and finalizing Quality Control (QC) Summaries
Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation Reports
Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs
Creating, modifying and finalizing paper Source Documents based on ToOs
Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
Attending internal and external meetings relating to the Site Manuals, IQA/PQA/QC Summaries, CRs/KPDs, Source Documents and any other MedComm-related study start-up documents
Running Scheduled Tasks for generating MedComm webpages
Maintaining MedComm document webpages
Checking MedComm webpages for errors
Performing Project Close-outs as they occur based on receipt of Study Closure forms
Reviewing and updating Charter Training Slides (CTS) and CTS quiz(zes) as needed
Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required
Manages the clinical study document development process by:
Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs
Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled
Providing guidance to assigned Project Teams and Project Team members
Providing language updates, as required, for all MedComm document templates as needed
Creating Final Effective documents
Secondary Responsibilities
Maintains Quality Service and Departmental Standards by:
Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
Updating department SOPs and Work Instructions as needed
Assisting in establishing and enforcing departmental standards
Contributes to team effort by:
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Participate in internal training activities
Helping others to achieve results
Performing other duties as assigned
Maintains Technical and Industry Knowledge by:
Staying up-to-date on response criteria publications posted by Medical Communications
Participating in Medical Writing Training activities, including creating/reviewing training modules
Participating in Clinical Project Management Training activities, including creating/reviewing training modules
Attending and participating in applicable company-sponsored training
Qualifications
Education:
Bachelor's Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred
Experience:
1+ years medical writing experience required
2+ years of experience in pharmaceutical/clinical/imaging research preferred
Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing
Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access)
Understanding and knowledge of medical and/or clinical trial terminology desired
Additional skill set:
Ability to work in a group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
Organization and time management skills for managing multiple projects concurrently
Additional Information
Working conditions:
Travel: 0-5%
Lifting: 0-10lbs
Other: Computer work for long periods of time
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic
$77k-116k yearly est. 1d ago
Medical Writer
Cs&S Staffing Solutions
Medical writer job in Princeton, NJ
Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx *You can apply through Indeed using mobile devices with this link.
Additional Information
$77k-116k yearly est. 1d ago
Medical Writer
CS&S Staffing Solutions
Medical writer job in Princeton, NJ
Please, review and apply for this position through the QCI system following the link below (Copy and Paste):
http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx
*You can apply through Indeed using mobile devices with this link.
Additional Information
$77k-116k yearly est. 60d+ ago
Medical Writer (Advanced Degree)
Octane Learning
Medical writer job in Princeton, NJ
THE COMPANY
Octane Learning is a professional learning and medical communications agency, working exclusively for pharmaceutical, biotech, medical device, and healthcare companies. We advise on learning strategies and create the right experiences, including online study, virtual, in-person and hybrid workshops, reference resources, sales/corporate training events, and more. We also work strategically with clients to create medical education for and outreach to healthcare professionals (HCPs) so they can make informed decisions in their practices.
As we are rapidly expanding and have an opportunity for a Scientific Writer/Content Specialist to join our team in Princeton, New Jersey.
THE LOCATION
This position requires work to be performed from our Princeton, NJ offices.
THE WORK
Reporting to the Director of Content and Strategy, you'll develop the content for: (1) several different styles of training, primarily interactive media such as eLearning, instructor-led courses/workshops, videos, and print resources; and (2) medical communications activities such as advisory boards, symposia, and speaker slide decks For these materials, within the constraints of our/clients' guidelines, you will:
Review client's goals and strategy
When appropriate, develop learning objectives, appropriate for the audience (role, level)
Create or select content (medical, legal, regulatory) that is accurate and flows logically
Apply general instructional design techniques, including (where appropriate) creating exercises and assessments, feedback, virtual meeting needs, ensuring materials are suitable for later translation, etc.
Obtain and incorporate input and insights from clients, subject matter experts (SMEs), key opinion leaders (KOLs), and other team members
Reference the content according to the established referencing standards
Provide additional strategic support, such as attending and developing executive summaries from advisory board meetings
Content spans life science company requirements, from medical to policy and procedures, compliance, etc. You'll be working primarily in Microsoft Word and Microsoft PowerPoint, often inside existing templates. You will work closely with internal team members to ensure successful project completion and delivery.
You'll also collaborate with your colleagues in the creative and development departments to help deliver the content in a way that is most impactful for the learner. This may involve a casual conversation or a brainstorming session to generate new ideas for presenting the information.
There will likely be opportunities for additional work in curriculum design, audit and gap analysis, content creation for marketing collateral, as well as learning strategy, as the workload presents, and your capacity/interest aligns.
As our work is collaborative, it will be necessary to work from our Princeton, NJ office, with some flexibility.
THE CANDIDATE
You have a Masters or Doctoral degree in a medical/scientific discipline.
You are proficient in PowerPoint and Word, with excellent writing and editorial skills - an English degree or minor is a plus.
You have the ability to convert scientific data into a clear, scientifically sound, well-structured 'story'.
You are well-organized, with strong attention to detail.
You have good presentation, communication, and interpersonal skills.
You should have the capacity to:
Work in a fast-paced environment, pivoting to the highest priority or client need
Bring creative ideas to the presentation and delivery of content
Faithfully execute written and verbal instructions and seek clarification, when needed
Work within established timelines and our clients' regulated environments
Attend project and client meetings, sometimes presenting your work
Consider or explore the needs and perspective of your audience
Speak your mind if you feel a project or process can be improved
Learn new things and cultivate your capabilities as the workload may dictate
THE FIT
We are more interested in finding the right talent and attitude than the exact match to a list of skills and qualifications. We're looking for someone that is excited and motivated to learn new things in creating learning/training/medical communications resources in scientific, compliance, and regulatory areas.
BENEFITS
Retirement Plan Matching
Medical Insurance
Dental Insurance
Vision Insurance
Disability Insurance
Paid Time Off
$77k-116k yearly est. Auto-Apply 60d+ ago
Medical Writer I
Lancesoft 4.5
Medical writer job in Raritan, NJ
The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The applicant should have experience using risk management methodologies, tools, incorporate appropriate data and information, and conduct risk calculations. The applicant must understand pharmaceutical and/or device manufacturing processes, design controls, and be able to lead and conduct FMEAs. Specific experience with user/design/process FMEAs for medical devices is desirable. A minimum of Five (5) years experience is required. The applicant should be proficient in Microsoft Word, Excel, Visio, Microsoft Project and have experience with documentation systems. The applicant must have experience in leading and facilitating teams to finalize reports with approvals per standard operating procedures.
The incumbent will work with medical, technical, manufacturing, and quality groups to develop Product Risk Assessments by conducting risk analysis for pharmaceutical products. Job Responsibilities include:
• Collate appropriate and pre-populating the document based on product information, patient/user information, and other supporting documents.
(the incumbent should have the ability to search these documents, understand the process and extract required information)
• Ensure proper formatting, proof read, and route for approval in documentation system.
• Maintain and update project status in Microsoft Project, excel.
Key Decisions:
• Participates in decisions and provides input and prepares product risk management reports regarding the adequacy, accuracy, interpretation, and clarity, and final decisions made by the project team.
• Consults with appropriate groups (as required) regarding the acceptability of documentation
Key Competencies:
Project Management
Organization and Time Management
Communication (Verbal, Written, and Interpersonal)
Qualifications
Education/Experience Requirements:
• Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry
• OR MS/PhD/Pharm.D. plus 3-4 years of pharmaceutical industrial experience
• Minimum of 1-2 years of technical writing experience for manufacturing related activities is mandatory
• Experience working in the Pharmaceutical manufacturing industry (preferably in Technical Services, Operations, manufacturing plant or Research & Development or QA, knowledge of pharmaceutical development processes, cGMPs and regulatory requirements are required.
• Excellent English, writing and oral presentation skills is mandatory
• Prior experience with Pharmaceutical Industry is mandatory
• Prior experience managing projects is preferred
Additional Information
Job Description:
Write technical materials, such as SOP's, appendices
Duties and Responsibilities:
• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.
• Maintain records and files of work and revisions
• Edit, standardize, or make changes to material prepared by other writers or establishment personnel
• 2+ years experience as a Technical Writer
• 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team
• Proofing/preparation of documentation
$82k-112k yearly est. 1d ago
Medical Writer Position
Integrated Resources 4.5
Medical writer job in Collegeville, PA
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
RESPONSIBILITIES:
• Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.
• High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
• Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
• Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders.
• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
• Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.
• Manage contract writers, as well as internal writers.
• Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses
TECHNICAL KNOWLEDGE:
• Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy.
• Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
• Able to complete and turn around high quality outputs with only minimal guidance from management.
Qualifications
QUALIFICATIONS AND SKILLS NEEDED:
• Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent.
• Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance.
• Experience with oncology and eCTD filing preferred.
Additional Information
Tel: 732-429-1921
http://www.irionline.com
$72k-103k yearly est. 1d ago
Medical Writer
Mjh Life Sciences, LLC
Medical writer job in Cranbury, NJ
At MJH Life Sciences our success is measured by your success! If you set your standards high and want to contribute to a winning team, we'll provide you with every opportunity to help grow our company and your career. Our associates come from all backgrounds, sharing one key quality: determination to succeed. We value being Service Focused, having a Passion for Winning, Innovation, Respect, Integrity, and Teamwork. Nothing means more to us than hiring people with these attributes. If you believe you're right for the job, this is the place to prove it!
As a MedicalWriter with the Enterprise Content Team at MJH Life Sciences , you will play a vital role in developing educational content for healthcare professional audiences. This position offers the opportunity to work on a wide range of projects, including discussion guides, slide decks, and video-based tools, while collaborating with leading experts across diverse fields. Your work will contribute to creating high-quality, scientifically accurate content that helps improve patient care outcomes.
Key Responsibilities:
· Conduct extensive literature reviews on various disease states, therapeutic advancements, and clinical data.
· Comprehend and apply relevant evidenced-based medical literature, clinical practice guidelines, and disease-state information for the development of content across various therapeutic areas (eg, identify levels of evidence, clinical trial data, clinical utility of therapeutic choices and unmet needs in treatment landscapes, product-specific education)
· Develop relevant, accurate, and high-quality content for digital, print, video, and event deliverables, ensuring adherence to in-house and AMA style guidelines.
· Write, edit, and revise content independently throughout the project lifecycle, incorporating feedback from faculty, internal teams, and other stakeholders.
· Ensure the scientific and clinical accuracy of all materials through comprehensive fact-checking of referenced literature.
· Attend professional conferences and events to capture key presentation highlights and create content for project deliverables (minimal travel required; 2-3 days per month).
· Collaborate effectively with cross-functional teams, including internal professional services, to ensure project success. Interface regularly with clients, key thought leaders, and faculty during meetings and project discussions.
Compensation Range:
$55,000- $60,000 per year, depending on qualifications. Eligible for annual company bonus program or commission incentive based on role. The compensation offered to the candidate selected for this position will depend on several factors, including the candidate's educational background, skills, and professional experience.
Benefits Overview:
We're proud to offer a comprehensive benefits package, including:
Hybrid work schedule
Health insurance through Cigna (medical & dental)
Vision coverage through VSP
Pharmacy benefits through OptumRx
FSA, HSA, Dependent Care FSA, and Limited Purpose FSA options
401(k) and Roth 401(k) with company match
Pet discount program with PetAssure
Norton LifeLock identity theft protection
Employee Assistance Program (EAP) through NYLGBS
Fertility benefits through Progyny
Commuter benefits
Company-paid Short-Term and Long-Term Disability
Voluntary Term Life & AD&D Insurance, plus Universal Life Insurance options
Supplemental Aflac coverage: Accident, Critical Illness, and Hospital Indemnity
Discounts and rewards through BenefitHub
#LI-Hybrid
MJH Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. All employees of MJH Life Sciences are employed “At Will.” This means that either the employee or the Company is free to end the employment relationship at any time, for any reason, with or without cause and with or without notice.
$55k-60k yearly Auto-Apply 60d+ ago
Medical Writer
Artech Information System 4.8
Medical writer job in Pennington, NJ
Artech Information System , a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you.
Position: MedicalWriter
Location: Pennington, New Jersey-08534
Duration: 6 Months
Job Description:
Scientific Writer for Aggregate Reports:
Coordinate and author documents needed for regulatory submissions (eg, CSRs, CTD summary documents, aggregate safety reports, risk management plans), ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
Review and edit documents as required.
Considerable experience in Assignment on Cross Functional Teams would be an advantage.
Qualifications:
PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents. In addition, (i) demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals, (ii) good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, (iii) demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team, (iv) working knowledge of a document management system and basic knowledge of document publishing process, (v) analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator's Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. 6. Able to collaborate with project team to respond to health authority questions, requests, etc.7. Provide departmental management with adequate information to help assess resource needs.
Additional Information
All your information will be kept confidential according to EEO guidelines.
$79k-111k yearly est. 1d ago
Principal Medical Writer
Icon Plc 4.8
Medical writer job in Blue Bell, PA
Principal MedicalWriter- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Principal MedicalWriter to join our diverse and dynamic team. As a Principal MedicalWriter at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards.
What You Will Be Doing:
* Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
* Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
* Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
* Mentoring and training junior medicalwriters, fostering a culture of excellence and professional growth.
* Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
Your Profile:
* Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
* Significant experience in medical writing, particularly in regulatory submissions and clinical documentation.
* Strong understanding of regulatory requirements and industry standards for clinical writing.
* Exceptional writing and editing skills, with a keen eye for detail and clarity.
* Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
* A commitment to maintaining high standards of quality and compliance in all medical writing activities.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$67k-93k yearly est. 52d ago
Medical Writer
Allen Spolden
Medical writer job in New Milford, NJ
The MedicalWriter will primarily work on the development and delivery of high -quality documents such as Clinical protocols, protocol amendments, Investigator's Brochures (IBs), non -clinical and clinical summaries together with integrated summaries (ISS and ISE), and other related clinical/regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications (NDAs) and Biologics License Applications (BLA) within agreed -upon timelines.
Education and Credentials
Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment
Bachelor's degree in life sciences or related disciplines; advance degree preferred (MD, PhD, PharmD, etc.)
Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus.
Skills
Ability to work independently and collaboratively in a team environment consisting of internal and external contributors
Experience in managing multiple projects simultaneously
Excellent problem -solving skills with the ability to adapt to changing priorities and deadlines.
Excellent interpersonal skills and ability to work with cross -functional teams to meet business objectives.
Ability to initiate and generate with limited supervision medical, regulatory, and clinical documents within a reasonable timeframe
Ability to develop document templates for ongoing and future submissions depending upon the scope of the project.
Ability to pivot from one project to another and multitask
Ability to understand client objectives and provide feedback that supports projects and deliverables in multiple therapeutic areas
Ability to move efficiently in a dynamic environment
Excellent verbal and written communication and listening skills.
Highly proficient with Microsoft Office.
Effective time management
Bilingual in Mandarin and English is not required, but will be a plus
Responsibilities
Prepares, edits, and finalizes various documents, medical and technical from non -Clinical / pre -clinical to Phase IV studies.
Serves as medical writing representative on cross -functional study teams and provides guidance on document strategy and content, timelines, and resource needs
Manages the document development process from start to finish which may include generating multiple draft documents and formulating final approved versions, editing, reference retrieval, as well as managing other various processes are undergone (i.e., internal & external reviews, quality checks, audits, formatting, publishing).
Collaborates with cross -functional team to ensure results and statistical interpretations are accurately and clearly reflected in documents.
Participates in all necessary cross -functional document development meetings (i.e., kick -off meetings, comment resolution meetings) to ensure appropriate alignment from different stakeholders.
Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables.
Monitors regulatory, clinical/medical, and scientific findings and conclusions ensuring key messages are clear and consistent within and across documents.
Provides editorial or review support for other types of documents as requested.
Maintains ongoing familiarity of US and international regulations, requirements and guidance associated with the preparation and submissions of clinical regulatory documents and scientific publications
Proponent of Good Publications Practice Guidelines and understand the importance of adhering to the rules and regulations of External Scientific Professional Organizations and scientific journals.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
5+ years of clinical research experience
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsContract - $60+/hr.
$60 hourly 60d+ ago
Editor in Chief / Deputy Editor ( Immunology)
John Wiley & Sons, Inc. 4.6
Medical writer job in Hoboken, NJ
Our mission is to unlock human potential. We welcome you for who you are, the background you bring, and we embrace individuals who get excited about learning. Bring your experiences, your perspectives, and your passion; it's in our differences that we empower the way the world learns.
About the Role:
About the Role:
We are seeking a highly motivated and strategic Editor-in-Chief/Deputy Editor to join Wiley's Advanced team, serving as Deputy Editor [Immunology] for our flagship journal, Advanced Science, and Editor-in-Chief of a related Advanced spin-off title. The ideal candidate will be a dedicated Advanced portfolio ambassador with an extensive global network in immunology and translational research, driving strategic initiatives that bridge groundbreaking research communities and shape how interdisciplinary science is published and shared worldwide. The Editor-in-Chief/Deputy Editor actively participates in the peer review process and decision-making for submitted manuscripts while ensuring adoption of best practices and the highest ethical standards in publishing.
How you will make an impact:
* Develop and execute strategic initiatives to grow Wiley's Advanced Portfolio within immunology globally.
* Commission high-quality papers and build collaborative relationships with leading researchers through community engagement to enhance content quality and brand influence.
* Collaborate with the global editorial team to manage manuscripts submitted from related subject areas for Advanced Science.
* Launch and oversee management of new Advanced spin-off titles in relevant subject areas as the brand expands.
* Manage titles within a team of in-house editors and involved in immunology cluster strategy
* Collaborate closely with marketing teams to devise and implement brand-enhancing events and initiatives for both short-term and long-term success.
* Lead generation and ideas for subject-related products passed on to appropriate colleagues
What we look for:
* PhD in Immunology related areas. Post-doctoral and clinical experience would be preferred.
* Manuscript handling experience (prescreening, peer review, final decision, appeals and integrity cases).
* Subject-Matter Expertise (academic).
* Strong global network within research communities and proven track record of engaging with top-tier research talents.
* Displays high integrity and honesty.
* Mindset with ability to identify opportunities and convert strategic visions into actionable plans.
* Excellent communication and relationship-building skills with both internal and external stakeholders.
* Love to travel (internationally).
More about the Job Description:
The Editor-in-Chief/Deputy Editor is entrusted with the strategic development and execution of initiatives aimed at growing Wiley's Advanced Portfolio within the disciplines of Immunology and related Life and Health Science disciplines. With an extensive global network, the Editor-in-Chief/Deputy Editor serves as a dedicated ambassador and advocate for Wiley's Advanced Portfolio in the immunology research community.
This role is pivotal for the advancement and expansion of a critically important brand, ensuring alignment with and achievement of the company's strategic goals and objectives. The Editor-in-Chief/Deputy Editor is tasked with converting strategic visions into actionable plans, identifying and seizing opportunities to meet the targets set for Research Publishing. In close collaboration with the marketing team, they will devise and implement a range of brand-enhancing events and initiatives aimed at both short-term and long-term success.
The Editor-in-Chief/Deputy Editor will concentrate on enriching the content and elevating the brand profile of Advanced Science, effectively directing excess submissions to relevant clusters within Wiley's Life and Health Sciences portfolio. Additionally, the Editor-in-Chief/Deputy Editor will launch one or more new spin off titles in the relevant subjects and oversee the management of the Advanced spin off titles.
By actively engaging with research communities, the Editor-in-Chief/Deputy Editor is committed to commissioning high-quality papers, extending the brand's influence, and forging positive, collaborative relationships with leading researchers. They approach their work with an understanding of the needs of both external and internal stakeholders, driving forward initiatives that connect with top-tier research talents.
The Editor-in-Chief/Deputy Editor will provide regular updates to the Senior Manager on community engagement efforts and journal development progress. These reports will include evidence of the impact made by the Immunology initiatives and demonstrate the successful delivery of strategic goals for Wiley's Advanced Portfolio. They will also outline programs and strategies designed to attract and retain authors, as well as to enhance the growth of high-quality content within Advanced Science, across the Advanced portfolio, and the related subject clusters.
About Wiley:
Wiley is a trusted leader in research and learning, our pioneering solutions and services are paving the way for knowledge seekers as they work to solve the world's most important challenges. We are advocates of advancement, empowering knowledge-seekers to transform today's biggest obstacles into tomorrow's brightest opportunities.
With over 200 years of experience in publishing, we continue to evolve knowledge seekers' steps into strides, illuminating their path forward to personal, educational, and professional success at every stage. Around the globe, we break down barriers for innovators, empowering them to advance discoveries in their fields, adapt their workforces, and shape minds.
Wiley is an equal opportunity/affirmative action employer. We evaluate all qualified applicants and treat all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, genetic information, or based on any individual's status in any group or class protected by applicable federal, state or local laws. Wiley is also committed to providing reasonable accommodation to applicants and employees with disabilities. Applicants who require accommodation to participate in the job application process may contact ******************* for assistance.
We are proud that our workplace promotes continual learning and internal mobility. Our values support courageous teammates, needle movers, and learning champions all while striving to support the health and well-being of all employees. We offer meeting-free Friday afternoons allowing more time for heads down work and professional development, and through a robust body of employee programing we facilitate a wide range of opportunities to foster community, learn, and grow.
We are committed to fair, transparent pay, and we strive to provide competitive compensation in addition to a comprehensive benefits package. It is anticipated that most qualified candidates will fall within the range, however the ultimate salary offered for this role may be higher or lower and will be set based on a variety of non-discriminatory factors, including but not limited to, geographic location, skills, and competencies. Wiley proactively displays target base pay range for United Kingdom, Canada and USA based roles.
When applying, please attach your resume/CV to be considered.
#LI-YZ1
$85k-109k yearly est. 15d ago
Senior Science Writer
News Writer/Reporter, Cancer Discovery In Boston, Massachusetts
Medical writer job in Philadelphia, PA
The Senior Science Writer in the Communications and Public Relations Department will assist the director of science communications in translating scientific data and information related to cancer research into content that helps educate the public, policymakers, media and the health care industry about cancer research advances, the AACR's mission, and the importance of biomedical science and funding. In this capacity, the senior science writer will assist the director in implementing the AACR's communications and public relations plans that facilitate the accurate communication and reporting of the latest advances in cancer research from the AACR's meetings, journals, partnerships, and other scientific activities.
Responsibilities
The Senior Science Writer writes and edits content that helps promote awareness of AACR's scientific activities among the public, policymakers, the media, and others interested in cancer research. Responsibilities include:
Writing and editing scientific press releases, blog posts, and features about cancer research advances from the AACR's conferences, journal articles, and other scientific sources.
Developing scientific content for the AACR websites and social media platforms.
Staying abreast of the latest developments in various areas of cancer research, including basic and translational research, population research, and preclinical and clinical research.
Researching and gathering information on scientific topics of interest and participating in the SciComm Journal Club.
Assisting with the development of scientific video content for blogs and websites.
Assisting with writing scripts and letters for leadership, newsletter, Annual Report, and other content.
Collaborating with SciComm members and media relations staff to help identify important cancer research advances from AACR's journals, scientific conferences, programs, and other initiatives to communicate to the scientific/medical press, national press, policymakers, cancer research community, and the public.
Occasionally traveling to AACR conferences and other scientific programs to cover important scientific advances on the blog and websites as required.
Collaborating with other members of the AACR about science communications projects that support the AACR's mission and goals.
Qualifications
Ability to translate complex scientific concepts into lay language for press releases and other written materials, including science backgrounders, blog posts, development activities, and reports.
Ability to write compelling science content for lay audiences.
Skill to develop scientific video content, including interviews and editing.
Possesses outstanding editing skills and knowledge of AP style guide.
Excellent interpersonal skills, including being a team player capable of working effectively with AACR colleagues, membership, and leadership.
Good understanding of biomedical terminology.
Proficiency in social media.
EDUCATION AND TRAINING:
PhD in biomedical science; cancer research experience preferred.
Minimum of seven years of experience writing science content for a variety of target audiences, including scientists, media, and lay readers.
How to Apply:
Please upload your resume and cover letter (required).
Equal Opportunity Employer
$63k-101k yearly est. Auto-Apply 60d+ ago
Editor In Chief at Revolutionary Startup Social Enterprise
Iflip4
Medical writer job in East Hanover, NJ
iFLIP4 is the brand and network for people who care. Our brand, called The Charitable Brand, donates over half of its profits to the charity of your choice. Our network is the place you go to learn about the issues that plague our planet, and to discover the solutions to them. iFLIP4 educates. It inspires. It empowers, all in the name of the world's greatest causes--and the best part: it's driven by you.
Pre-launch, we have been featured in the New York Post, and we were unanimously selected to receive the C.V. Starr Social Entrepreneurship Fellowship.
iFLIP4.com has been accessed in 100+ countries, and we have hundreds of iFLIP4 Ambassadors (campus representatives) on 45 college and high school campuses in the US, UK, and Canada.
Job Description
We want to change the world. We're a team of fast-executing social entrepreneurs on a mission to build the future of social change. We're looking for a visionary editor who wants to use multimedia content to change lives, change minds, and equip our generation with tools to change the world.
You will be in charge of one of the most integral parts of iFLIP4: content. From articles to videos to interviews to games, iFLIP4's content educates, empowers, fosters discussion and inspires action.
We don't want someone who will just say yes and implement every little thing we ask for. What we want is a partner. Someone to bounce ideas off of, someone with a vision for the future of our company, and someone who has the desire and drive to make it a reality.
KEY RESPONSIBILITIES
Conceptualize and execute iFLIP4's editorial strategy
Recruit, train and manage a national network of part-time editors, correspondents, and freelance writers to produce groundbreaking multimedia content
Write, copy-edit, code, schedule editorial content, and tailor headlines for social media and SEO
Analyze performance metrics for web content and evaluate or change editorial strategy based on findings
Work hand in hand with other members of the Core Team to create and distribute innovative content campaigns
Qualifications
Excellent writing and editing skills
Experience recruiting and managing volunteer writers and editors
Online content production experience, including knowledge of basic HTML and Content Management Systems (CMS)
You understand the type of content Millennials want and how they will interact with it
You have a desire to use your leadership, creativity and passion to change the world
Additional Information
This position will begin as part-time at about 15 hours/week with a small stipend. As we grow and complete our Angel round of funding, we will address expansion to a full time position with a full salary and vested equity. We are located in East Hanover, NJ, and telecommuting is fine with us.
If you're responsible, driven, and innovative, we want to hear from you! Preference will be given to those who apply earliest.
How much does a medical writer earn in Bethlehem, PA?
The average medical writer in Bethlehem, PA earns between $58,000 and $124,000 annually. This compares to the national average medical writer range of $63,000 to $137,000.