Senior Technical Writer
Medical writer job in Bridgewater, NJ
The Senior Technical Writer will be responsible for authoring, reviewing, and maintaining high-quality CMC and GMP documentation to support development, manufacturing, testing, and regulatory submissions for radiopharmaceutical products. This role is heavily focused on analytical methods, validation protocols/reports, batch records, and product development reports, ensuring that all documentation is scientifically sound, inspection-ready, and aligned with applicable regulatory and quality standards (e.g., GMP, ICH, FDA, EMA).
The ideal candidate combines strong technical understanding of radiopharmaceuticals or sterile drug products with excellent writing, data interpretation, and cross-functional collaboration skills.
Key Responsibilities
1. Technical Document Authoring & Review
· Draft, edit, and finalize technical documents including, but not limited to:
· Analytical method development and validation protocols/reports
· Equipment qualification and validation protocols/reports
· Master batch records (MBRs) and associated controlled forms
· Product development reports, technical summaries, and investigation reports
· Stability protocols and reports
· Specifications and test methods for raw materials, intermediates, and finished radiopharmaceutical products
· Ensure documents are clear, concise, scientifically accurate, and consistent with internal templates and style guides.
· Translate complex technical data and experimental outcomes into well-structured, comprehensible documents for both technical and regulatory audiences.
2. GMP & Regulatory Compliance
· Ensure all documentation complies with GMP, ICH guidelines, and relevant regional regulations (e.g., FDA, EMA) for radiopharmaceuticals and sterile products.
· Incorporate appropriate data integrity and 21 CFR Part 11 principles into documentation practices.
· Support the preparation of CMC sections of regulatory submissions (e.g., IND/CTA, NDA/MAA, DMFs) by providing high-quality source documents and summaries.
3. Cross-Functional Collaboration
· Work closely with Analytical Development, Product Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to gather data and technical content.
· Facilitate document review cycles, consolidating and addressing comments from multiple stakeholders.
· Participate in project meetings to understand technical strategies, timelines, and document needs.
4. Document Control & Lifecycle Management
· Prepare documents in alignment with document control procedures and manage revisions through the electronic quality management system (eQMS or DMS).
· Own the lifecycle of key documents, ensuring timely updates following process changes, validation activities, or regulatory feedback.
· Support preparation for audits and inspections by ensuring documentation is complete, organized, and readily retrievable.
5. Continuous Improvement
· Contribute to the development and refinement of templates, style guides, and best practices for technical documentation.
· Provide guidance and mentoring to junior writers or subject matter experts (SMEs) on effective technical writing and documentation standards.
· Identify opportunities to streamline documentation processes and improve consistency and quality.
Qualifications
Required:
· Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Radiopharmacy, or a related scientific discipline.
· 5-8+ years of experience in technical writing within the pharmaceutical, biotech, or radiopharmaceutical industry, preferably in a GMP environment.
· Demonstrated experience authoring analytical method validation protocols/reports, batch records, and other CMC/GMP documentation.
· Strong understanding of GMP, ICH Q guidelines, and regulatory expectations for sterile injectable or radiopharmaceutical products.
· Proven ability to interpret analytical and process data and present it clearly in written form.
· Excellent written and verbal communication skills in English, with strong attention to detail, organization, and consistency.
Preferred:
· Experience in radiopharmaceuticals, nuclear medicine, or other short-lived isotope-based products.
· Familiarity with aseptic processing, cleanroom operations, and QC testing relevant to radiopharmaceuticals (e.g., sterility, endotoxin, radionuclidic purity, radiochemical purity).
· Experience contributing to CMC sections for regulatory submissions (IND/CTA, NDA/MAA, ANDA, or equivalent).
· Proficiency with electronic document management systems (eQMS/DMS) and standard office tools (Word, Excel, PowerPoint).
Key Competencies
· Strong scientific and technical literacy, with the ability to quickly understand new processes and analytical methods.
· Exceptional technical writing and editing skills, with a focus on clarity, structure, and data integrity.
· High level of ownership, accountability, and ability to manage multiple documents and deadlines in parallel.
· Collaborative mindset with the ability to work effectively across multi-disciplinary teams.
· Detail-oriented, quality-focused, and comfortable working in a regulated environment.
Technical Writer | Contract W2
Medical writer job in Berkeley Heights, NJ
Job Title: Technical Writer (Cards and Payments)
with Next Gen Software Solutions LLC
Work Schedule: 5 days a week onsite
Experience: 10 to 12 Years of industry experience
Job Description:
Industry Knowledge: Banking, Payment and Credit Card domain experience
Research and Information Gathering: Interviewing product managers, studying product samples, and gathering data to understand the product's features and functionality.
Content Creation: Writing, editing, and proofreading content for accuracy, clarity, and consistency.
Audience Analysis: Assessing the needs and technical knowledge of the intended audience (e.g., end-users, technicians, or developers) to adjust the tone and technical level of the documentation.
Documentation Management: Organizing information, creating diagrams, charts, or other visual aids, and managing documentation systems (such as content management systems or wikis). Collaboration: Working with cross-functional teams, including engineering, QA, and customer support, to ensure documentation aligns with product development and user needs.
Review and Testing: Incorporating user feedback to update and improve content and testing documentation for usability and accuracy.
Key Skills and Qualifications
Employers typically look for a combination of strong communication skills and technical aptitude:
Excellent Writing Skills: The ability to present complex information clearly and succinctly, with a strong grasp of grammar, style, and syntax.
Technical Aptitude: A strong interest in and the ability to quickly grasp technical concepts and new tools. A background or degree in a relevant technical field (e.g., computer science, engineering) can be beneficial.
Attention to Detail: Meticulous proofreading and editing skills to ensure accuracy and functionality.
Research and Analytical Skills: The capacity to break down complex data, analyze information, and organize it logically for the reader.
Collaboration and Communication: Strong interpersonal skills for effectively communicating with diverse teams and stakeholders.
Software Proficiency: Familiarity with documentation tools (e.g., MadCap Flare, Oxygen XML Author), content management systems (CMS), and common office software (e.g., Microsoft Office Suite).
Typical Documentation Types
Technical writers produce a variety of materials depending on the industry:
User manuals and guides
Installation and configuration instructions
Online help sections and FAQs
API developer guides
About Next Gen Software Solutions LLC:
Next Gen Software Solutions is a trusted provider of IT Staffing and consulting services dedicated to empowering businesses with cutting-edge technology solutions and exceptional talent. We specialize in delivering tailored IT consulting services, innovative software solutions, and connecting businesses with highly skilled IT professionals. Founded and led by a dedicated U.S. Army solider, Next Gen Software Solutions is deeply rooted in the core values of integrity, discipline, commitment, and experience-principles that guide every aspect of our operations.
Equal Employment Opportunity Statement:
Next Gen Software Solutions LLC is an Equal Opportunity Employer. We are committed to fostering an inclusive and diverse workplace where all employees and applicants are treated respect and dignity. We do not discriminate based on race, colour, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, genetic information, veteran status, or any other legally protected characteristic under applicable federal, state, or local laws.
Technical Writer
Medical writer job in New York, NY
Job Title: Technical Writer / Analyst
Primary Location: New York, NY 10004
Work Location: Onsite at 2 Broadway with travel to other CLIENT locations within the CLIENT Service Territory as required
Work Schedule: 35 hours per week, Monday-Friday
Duration: 12 Months
Position Overview
The Technical Writer / Analyst will support the Client by coordinating, documenting, tracking, and reporting on a portfolio of agency-wide security initiatives. This role provides direct support to senior leadership in strategic planning, prioritisation, and execution of security programs that protect CLIENT customers, employees, and critical infrastructure.
The Analyst will work closely with project managers and cross-functional stakeholders to ensure security initiatives are clearly documented, effectively tracked, and aligned with CLIENT security standards, schedules, and funding constraints.
Key Responsibilities
Coordinate and support physical and technical security projects across CLIENT agencies.
Track project scope, schedules, milestones, risks, and deliverables to ensure alignment with Office of Security priorities
Assist project managers with planning, execution, and reporting of security initiatives
Develop, review, and maintain technical documentation, policies, procedures, and program reports
Prepare executive-level presentations, dashboards, briefings, and written status updates
Facilitate meetings and discussions with internal stakeholders, operating agencies, and vendors
Identify project risks, resource gaps, and dependencies; recommend mitigation strategies
Support budget tracking, expenditure monitoring, and cost-control reporting
Ensure compliance with CLIENT security standards, governance policies, and operational requirements
Key Deliverables
Agency Security Program Support
Assist with performance reviews and continuous improvement of CLIENT security programs
Project & Budget Support
Monitor project budgets and assist in financial reporting
Support development and maintenance of the CLIENT video library, including footage tracking for operational insight and incident documentation
Project Tracking & Performance Metrics
Track assigned projects and provide regular progress updates to Office of Security leadership
Stakeholder Coordination & Policy Review
Coordinate with stakeholders to ensure security systems, protocols, and policies are reviewed and updated as required
Technology Research & Vendor Assessment
Conduct research and evaluation of emerging security technologies and vendors, including AI-enabled surveillance and analytics tools
Program & Presentation Support
Support tactical security programs such as drone initiatives and deployable camera development through reporting and documentation
Financial & Reporting Deliverables
Prepare budget tracking documents and financial reports aligned with funding allocations
Required Qualifications
Experience
1-3 years of experience in project coordination, project management, or analyst roles
Experience supporting physical security or technical system deployments preferred
Education
Bachelor's degree in Project Management, Engineering, Computer Science, Information Systems, or a related technical discipline
Technical Knowledge
General understanding of project management principles
Familiarity with video management systems and security camera technologies
Basic understanding of IT networking concepts (protocols, encryption, VPNs, operating systems)
General understanding of low-voltage/electrical principles related to security systems
Understanding of the engineering design lifecycle and SDLC
Core Skills
Strong technical writing and documentation skills
Excellent verbal communication and stakeholder coordination abilities
Strong organizational, analytical, and time-management skills
Preferred Qualifications
Lean Six Sigma certification or training
Experience in public-sector, transportation, or critical infrastructure environments
Director, Medical Writer
Medical writer job in New York, NY
The Director, Medical Writing will be an integral position working with the Clinical Development function to facilitate the translation of complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, the incumbent will lead the development of various documents that support our clinical trials, research/publications and regulatory activities.
This role requires strong writing and communication skills to effectively convey complex clinical and scientific concepts in a clear and concise manner. Attention to detail and a commitment to producing accurate and high-quality written materials are essential. Proficiency with Microsoft Office Suite and familiarity with scientific writing tools are required. Knowledge of clinical research, regulatory requirements, and biotechnology are desired. Candidates need to be comfortable in a fast-paced and collaborative work environment and able to work effectively with cross-functional teams.
Job Responsibilities
Lead and execute on the creation of a wide range of medical and scientific documents, including briefing books, clinical study protocols, investigator brochures, regulatory submissions, and scientific publications.
Collaborate closely with cross-functional teams to collect, interpret, and synthesize data, ensuring accuracy and relevance in written materials.
Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards.
Conduct comprehensive literature reviews to support the development of evidence-based documents.
Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences.
Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy.
Contribute to the strategic planning and execution of medical writing projects to support research and development initiatives.
Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines.
Education and Experiences
Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline).
Proficiency in Microsoft Office Suite and familiarity with scientific writing tools.
Demonstrated experience with regulatory submissions (IND, NDA) and a deep understanding of regulatory requirements and guidelines (FDA, EMA, ICH).
Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
Technical Skills/Core Competencies
Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
Strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner.
Exceptional attention to detail and commitment to producing accurate and high-quality written materials.
Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
Comfortable working in fast paced entrepreneurial environment
Ability to travel up to 20%
Salary Range: $170,000-185,000
Auto-ApplyMedical Writer (Must Have EU MDR)
Medical writer job in Franklin Lakes, NJ
The Medical Writer in client Medical Pharmaceutical Systems Medical Affairs is responsible for the generation and development of documents relating to Clinical and Human Factors assessments, evaluations and post market surveillance summaries.
Within this role, the Medical Writer will write and update Clinical Development Plans, Human Factor Engineering (HFE) Reports and other associated clinical and Human Factors (HF) documents.
The medical writer is a pivotal role to ensure compliance with associated regulations and pivotal in ensuring that there is available evidence to support the safety and performance of the products designed, produced and manufactured by the company.
The Medical Writer will perform and document systematic literature reviews, critically evaluate identified data, and will interface with various members of the Medical Affairs team and with cross-functional team members in order to achieve high-quality clinical and Human Factors documents.
The Medical Writer is also responsible for the development or review of study-related documents, including Clinical and Human Factors study executive summaries and related power point presentations.
The Medical Writer will be an integral part of the global Medical Affairs team and will collaborate with Medical Affairs leaders, Clinical and HF program leaders, Clinical and HF specialists and other key associates.
The Medical Writer is also responsible for optimizing processes for clinical evaluation and investigation as they relate to medical writing.
This role requires great familiarity and application of the associated regulations and guidance, including MDR (2017/745), MDD, MEDDEV 2.7.1 Rev. 4 and other MEDDEV guidances, ISO 14155, 21 CFR 812.
This role will report to the Associate Director, Medical Affairs in Franklin Lakes, NJ.
Job Functions:
Create and update Clinical Development Plans in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR.
Contribute to the Summary of Safety and Clinical Performance in alignment with EU MDR.
Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as any ad hoc reports required.
Develop and manage CER project plans and timelines.
Serve as a subject matter expert on clinical aspects of Technical documentation.
Analyze available clinical evidence (data held by the manufacturer, published literature) to assist the Medical Affairs team with clinical development strategy.
Write and or edit clinical documentation, including but not limited to clinical development plans, HFE reports, Health Hazard Evaluations. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution.
Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals or congresses.
Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission.
Write and/or contribute to abstracts and submissions of clinical and HF data to various medical device congresses or symposia.
Work with Medical Affairs and cross functional associates to ensure high quality submissions and data integrity.
Contribute to the development and optimization of Medical Affairs SOPs.
Support and assist Medical Affairs team members in the generation of effective visual and written communication.
Required Knowledge, Skills and Abilities
Strong interpersonal and communication skills.
Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives.
Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions.
Outstanding oral and written communication skills.
Proven experience performing literature reviews, analyzing data and communicating outputs. Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review tools a plus.
Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidances, including 2.7/1 Revision 4 and 2.12/2 Revision 2, ISO 14155, ICH guidance including E3 CSR, E6 (R2) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO 14971). Familiarity with FDA guidance documents related to Human Factors Engineering.
Demonstrated ability to work independently and as part of a team.
Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
Ability to work with a minimum of supervision.
Ability to work in a team environment.
Advanced skills using Microsoft Office products such as Outlook, Word, Excel and PowerPoint.
Minimum Requirements:
Bachelors in a relevant discipline required. Master's degree or PhD preferred
3 years of experience as a medical writer
3 years direct experience working on clinical evaluations within the Medical Device industry.
Medical writing certification a plus
Experience:
literature search engines PubMed, Embase: 1 year (Required)
ISO 13485 and ISO 14971: 1 year (Required)
EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance: 1 year (Preferred)
Medical Writer I, II or III
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 Medical Writer 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
Auto-ApplyMedical Writer
Medical writer job in Madison, NJ
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.
This is Direct Hire Position with one of our Clients
Job Description-
• The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products.
• This will be achieved by applying analytical skills, functional literacy and expertise in document preparation.
• The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, REMS, key sections of the Investigator's Brochure, the Annual Safety Report and regulatory briefing documents.
• Individual will create and foster an environment of partnership with other members of product teams, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors.
RESPONSIBILITIES:
• Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.
• For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
• Author documents such as agency briefing documents, key sections of the Investigator's Brochure, the Annual Safety Report and the core data sheet.
• 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.
• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables).
• Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management.
• Serve as the point of contact (“go to” person) for one or more projects or products.
• Organize and lead a MD matrix team of authors to deliver all MDL deliverables for each assigned project.
• Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents
Technical Skill Requirements:
• 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 think creatively and to develop strategic plans that demonstrate sound judgment.
• Exhibits sound project management and time management skills.
• Able to interact effectively with all levels/roles of project team members.
• Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
• Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise.
• Is able to implement systems and processes and suggest process improvements.
• Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines.
•
• Able to complete and turn around high quality outputs with only minimal guidance from management
Qualifications
• Scientific/medical academic background (e.g. PharmD/PhD or MSc/BSc with experience),
or equivalent.
• BS degree and 1 or more years of pharmaceutical experience preferred.
• An advanced degree preferred and at least 3 years medical writing
experience and /or experience in pharmaceutical development.
• 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 non-scientific audiences.
• Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory
guidance.
• Able to clearly articulate scientific and clinical data in all written and verbal
communication.
• May include a track record of leadership abilities either as a direct supervisor or within a
matrix setting
Additional Information
Medical Writer
Medical writer job in New York, NY
We are currently looking for freelance medical writers for one of our esteemed client and this opportunity will primarily involve writing case reports and will sometimes include a mix of both editing and developmental writing.
Apply here : https:\/\/**************************************************************************
The primary responsibilities are listed below:
Position: Medical Writer
Basic requirements: Experience in writing manuscripts.
Primary responsibilities:
· You will have to work with clients to understand the nature of the scientific work that they will be covering. You will have to assess the case using your medical expertise and also be open to developing expertise in new areas of writing
· You will have to compile, write, and edit medical writing deliverables covering all phases of research for submission to journals\/regulatory agencies
· You must be well versed with all the major style guides (e.g., AMA, APA, CSE)
· You must have good knowledge of ICH GCP, ISMPP, CONSORT, COPE, and\/or ICMJE guidelines
· Be adept at doing literature review
· Reliability, flexibility, and responsiveness
· Expertise and diligence in handling deadlines
A glimpse at what you would edit:
You will be assigned theses\/dissertations of varying difficulty levels (in terms of original English level, subject matter expertise, and the extent of revision needed), written by native and non\-native speakers. These will be primarily written by graduate\/masters\/PhD students pursuing their diplomas\/degrees\/doctorates. The thesis editor's role is to proofread\/edit their theses\/dissertations to ensure successful submission and to provide suggestions\/critique to improve their academic writing skills.
You should ensure:
Immaculate grammar, punctuation, sentence structure, and word choice
Flow, transition, and coherence
Preservation of the author's intended meaning
Application of academic editing conventions and style (e.g., citation style, layout, section headings, and tense usage)
When requested by our clients, formatting of theses\/dissertations according to the guidelines provided by the institution\/style guide (basic familiarity with style guides such as AMA, APA, MLA, and CMOS will be preferred).
Enago will ensure
Possibility of a guaranteed monthly income while freelancing: Apart from offering work in the typical freelancing manner, we also offer opportunities that guarantee a minimum monthly\/annual income, along with the possibility of an additional annual bonus (monetary), based on your performance.
Our fees are decided as per a pricing grid that takes into account different factors such as qualification, years of relevant experience, industry standards, etc. Most importantly it is decided after an applicant edits a doctored editing sample test.
A smooth performance\-driven progression curve with an effective feedback mechanism: This ensures that the expectation mismatch is nearly zero. In the past, the strong professional bonding with our freelance editors has also led to mutual recommendations-a definite plus factor!
A rewarding experience, both monetarily and intellectually: You will get the opportunity to apply your domain knowledge and skills to help non\-native authors present their work to the academia.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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Principal Medical Writer (Contract)
Medical writer job in New York, NY
The Principal Medical Writer at Compass Pathways is responsible for developing various clinical regulatory documents related to our investigational product, our proprietary psilocybin therapy. This person leads document preparation, ensures adherence to regulatory and company standards, coordinates outsourced writing services, and collaborates with multidisciplinary teams to support the regulatory sciences function.
Location: Hybrid in our New York City office or remote on the east coast in the United States.
Reports to: Associate Director, Medical Writing.
Duration: 12-month contract.
Roles and responsibilities
Responsibilities include (but are not limited to):
* Leads preparation of clinical regulatory documents, including CSRs, protocols, IB and clinical summaries (Module 2.7.x and ISE/ISS)
* Ensures Compass clinical documents are clear, accurate, and written in accordance with the relevant guidance and best practice
* Oversees and co-ordinates outsourced medical writing services as required
* Provides subject matter expertise as a member of the regulatory sciences team
* Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System; ensuring participant safety, data integrity and accuracy throughout the trial process
Candidate profile:
* Minimally a Bachelor's degree in the life or health sciences; MSc or PhD preferred
* Considerable experience in regulatory medical writing within the pharmaceutical/medical industry/CRO
* Experience in leading the development of clinical documents as part of a multi‑functional team, including CSRs, IBs, clinical summaries, ISS/ISE)
* Broad working knowledge of the clinical drug development process with experience of integrating information into clinical regulatory documents
* Knowledge of relevant ICH guidance relating to clinical regulatory documentation
* Excellent written English with aptitude for clear and concise writing
* Excellent attention to detail and editorial skills
* Flexibility in adapting to changing circumstances or new information
* Alignment to our company culture and values
Auto-ApplyLead Medical Writer
Medical writer job in New York, NY
Job Title: Lead Medical Writer
JOB PURPOSE
Lead the medical writing team for accounts that require multiple writers to meet the content demands of customized medical communications initiatives, and/or lead multiple accounts.
JOB RESPONSIBILITIES
With minimal direction or supervision, responsible for assigned-client service: provide high-quality editorial oversight for all content including planning through review; maintain knowledge of project status (content development and review) to ensure editorial quality and successful completion of all client content projects; identify and develop new opportunities for projects (working with the account manager) and publications (working with the publications manager); interact with account manager, publications managers, and project managers to ensure adherence to timelines and deliverables.
RESPONSIBILITY/PERFORMANCE MEASUREMENT
Content Development
Work closely with assigned project management team to ensure high-quality editorial implementation of all assigned-client programs.
· Effectively provides the information people need to know to do their jobs and to feel good about being a member of the assigned-client project team
· Provides medical writers information and direction so that they can draft accurate, high-quality editorial content; serves as a resource for questions
· Assesses potential projects to provide an estimate of writing time required for completion
· Reviews content for the assigned-client projects and ensures that content reflects clients' objectives and preferences while staying on time and on budget
· Cultivates and shares expertise in assigned therapeutic areas
· Delegates tasks and decisions in a professional manner, sets clear objectives, and trusts people to perform
· Shares responsibility and accountability for assigned-client projects
· Consistently complies with Fishawack standard editorial procedures, including ethical standards
Communication
Effectively and proactively communicate with team members (editorial, project, client), authors/faculty, and vendors in areas related to project completion.
· Ensures that information is communicated effectively
within
and
across
internal teams in a timely manner
· Keeps project team and manager apprised of project(s) status (through weekly status meetings or routine email communications) and challenges encountered during the project (eg, changes in scope, delays in receiving comments) to ensure project completion on time and on budget
· Proactively provides input to team members to enhance project outcomes
· Prioritizes workload for medical writers on team
· Offers to assist others in times of slow workloads and asks for assistance during times of heavy workloads
Business Development
Investigate, conceptualize, and strategize new medical communications projects and publications to support the assigned-client's needs and opportunities.
· Supports account manager's efforts to identify and secure new business for assigned client in a timely manner
· Understands scope of Fishawack's capabilities and how to tailor Fishawack's services to assigned-client's needs
· Effectively identifies opportunities for content development for assigned client
Company Representation
Represent the company at client meetings (eg, advisory boards, speaker-training meetings, business development initiatives) in a professional manner.
· Serves as onsite editorial resource and content expert in a professional manner
· Reviews and revises program content, as needed in an accurate and timely manner
· Prepares speakers for their presentations in a professional manner
· Anticipates additional onsite needs and proactively prepares for these needs
· Proactively assists project team; acts as a collaborative team member
· Is prepared to discuss topline information pertaining to content of business development meetings; educates internal, nonmedical team members about content-related issues
REQUIRED KNOWLEDGE, SKILLS, & ABILITIES
(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, skills, and ability required.)
Education
Required: 4 year post secondary education, or equivalent experience
Bachelor's degree in the life sciences; PharmD or PhD highly preferred
Experience
5+ years of medical writing experience; 5+ years of editorial process experience; 2+ years of experience with assigned-client's projects
Medical Writer
Medical writer job in Pearl River, NY
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.
Qualifications
Clinical data checking, consistency checking, and editorial review
Occasional travel to either Pearl River or Collegeville site for team meetings.
3-5 years
BA/BS
Additional Information
$46/hr
12 months
Medical Writer
Medical writer job in Peapack and Gladstone, NJ
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
• Create documents pertaining to clinical data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization (new drug) applications (Clinical Overviews and ICH module 2.7 clinical summaries), and responses to clinical and safety questions from regulatory authorities.
• Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
• Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
• Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project.
• Support clinical teams by providing analyses of clinical data, reviews of the medical literature, and similar related activities.
Responsibilities
• Communicate clinical's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
• Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.
• Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
• If leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team.
• Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.
•Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
• Develop and sustain constructive relationships within other Pharmaceutical lines including country organizations.
• If assigned by manager, serve as the clinical 'point of contact' for all document issues for a given product or set of products.
• Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line.
Position Comments visible to MSP and Supplier:
Additional Skills:Technical Skills:
• Writing skills. Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
• Analytic skills. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
• Oral presentation skills. Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences
• Language skills. High fluency in written English and strong functional fluency in spoken English. Knowledge of additional languages is an asset.
• Personal skills. Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• Interpersonal skills. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
• Regulatory knowledge. Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
• Software. Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred.
• Statistics. Proficiency with statistical concepts
Additional Information
Regards,
Anuj Mehta
************
Senior Medical Writer
Medical writer job in Jersey City, NJ
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.
This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You'll Do
Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
Help to iteratively improve medical writing processes as appropriate.
Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope.
Qualifications
Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
Substantial clinical study protocol writing experience desired.
Excellent communication, presentation, and project management skills.
Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
Working knowledge of statistical concepts and techniques.
Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
Familiarity with concepts of structured content management preferred.
Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Auto-ApplySr. Scientific Medical Writer (Montville, NJ)
Medical writer job in New York, NY
SourcePro Search has a fantastic opportunity for a Senior Scientific Medical Writer with a leading pharmaceutical company in Montville, NJ. offers an excellent compensation/benefits package as well as relocation assistance. Description: Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. Provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
Assuring quality and timely preparation of clinical documents across all therapeutic areas as assigned, including clinical study reports, clinical study protocols, investigator's brochures, clinical summaries and overviews.
Assist in the development of clinical document content used to support successful global clinical development, approval and marketing of a drug.
Implement the medical communication strategy for all regulatory submission documents as assigned.
Use the Global Target Label (GTL) and all associated product strategy documents to effectively develop associated clinical documents in support of the Global Clinical Development Plan (CDP), validate individual study protocol design and clinical study report (CSR) key messages, and provide key messages for submission dossiers used to gain marketing approval for the assigned documents.
Implement project level data presentation and messaging standards for the assigned documents.
Independently author submission and study level documents (collaborating with the team) based on the strategy provided and is accountable for the format, content and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
Mentor and coach associate scientific medical writers in the Global Medical Writing (GMW) department.
REQUIREMENTS:
Master's degree or equivalent with at least 4-5 years of experience in the pharmaceutical industry in total, including a minimum of 4 years in Medical Writing and demonstrated working knowledge of scientific principles.
PhD degree or equivalent with at least 3-4 years of experience in the pharmaceutical industry in total, including a minimum of 3 years in Medical Writing and demonstrated working knowledge of scientific principles.
Must have experience in developing clinical documents in support of regulatory submissions globally (i.e. multiple regions) in more than one therapeutic area.
Must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA).
Must have experience in electronic document management and electronic regulatory submissions, tools and standards.
Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
Must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Global Development organization.
****************************
Medical Writer
Medical writer job in New Milford, NJ
The Medical Writer 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.
Senior Medical Writer
Medical writer job in New York, NY
Flywheel (flywheelpartners.com) is a communications, education and training agency that supports leading healthcare companies by developing innovative medical and science educational resources - including but not limited to, eLearning modules, slide presentations, product brochures, backgrounders, videos, podcasts, learning games and skills development workshops. We partner with pharmaceutical, medical device, and biotech companies to drive enhanced clinical dialogue with healthcare providers, resulting in improved patient outcomes when using their products.
We are critical thinkers who enjoy what we do. We value people who are entrepreneurial, low-maintenance, curious, and humble. And we're looking for people who fit that profile to help take our business to the next level.
PRIMARY RESPONSIBILITIESCollaborate with a multi-functional account team to develop innovative medical and scientific educational materials tailored to our clients' needs. The audiences for whom we develop solutions are predominantly pharmaceutical sales forces, account managers, clinical educators, and medical affairs.
Writing/Content Development
Research, learn, and simplify complex scientific/medical information, ensuring it is clearly communicated to the target audience
Reference check, proofread, and copy edit to ensure accuracy, clarity, and quality
Client Relationships
Consult with client project owners and subject matter experts (SMEs) to create engaging and effective educational content covering a broad range of topics-pharmaceutical drugs, medical and scientific information (ie, anatomy & physiology, disease state, diagnosis, treatment, marketplace), market access, the business of healthcare, and selling skills/soft skills
Lead scheduled status calls and client review meetings with Medical, Marketing, Sales, Legal, and Regulatory
Expertise in client business, brands, and organizational structure
Communicate clearly to client-based peers; help foster client relationships by building rapport and trust
Professional Development
Learn the Flywheel pathways for advancement within the Medical Writer track, or other roles based on interest and capabilities
Take initiative to pursue development opportunities
Be proactive and provide solutions
DESIRED SKILLS AND EXPERIENCE
Education + Experience
Minimum three years of medical/scientific writing experience creating educational, instructional, or training materials at an agency, scientific journal, or in a healthcare setting
Expertise writing in multimedia formats
Advanced Degree (eg, MA, MS, PhD) in life sciences, healthcare, communications, journalism, or medical/scientific writing
Client relationship experience is preferred
Instructional design and visual design experience is preferred
Skills
Excellent communication (written and verbal), interpersonal, and presentation skills
Superior organizational skills and exacting attention to detail and factual accuracy
Referencing, proofreading, and copy editing skills
High proficiency in Microsoft Word and PowerPoint, Google Suite, Adobe Acrobat, and scientific web research
Ability to meet tight deadlines and manage multiple projects simultaneously
Excellent time management skills and strong ability to meet tight deadlines and manage multiple projects simultaneously
Ability to contribute and continuously adapt in a client environment where the one constant is “change”
Disciplined self-starter who can manage focus, communication, and the necessary workload in a remote environment
Salary Range: $85K - $100K per year.
Flywheel Partners LLC. provides Equal Employment Opportunities to all employees and applicants for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, physical or mental disability, pregnancy, veteran or military status, genetic information, sexual orientation, gender identity or expression, marital status, civil union/domestic partnership status, familial status, domestic violence victim status, or any other legally recognized protected basis under federal, state or local laws. The Company complies with applicable federal, state and local laws governing nondiscrimination in employment in every location in which the company operates. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please inform the Associate Director, Operations if you need assistance completing this application or to otherwise participate in the application process.
Privacy Policy: **************************************
Auto-ApplyMedical editor/writer
Medical writer job in New York, NY
Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at *************************
Title: Medical editor/writer
Location: New York City
Duration: 3 Months contract to hire
Job Description:
Medscape
TV editors will develop story boards for each sponsored TV show,
including an outline for 6 episodes per TV show. He/she will research
the topic and identify experts to develop the content, then coordinate
the on-site TV shoot, and work with video editors to produce the final
TV shows. Additional work will include developing supporting materials
for the landing page and assuring that all required assets are provided
to production.
Serve as editorial producer of multi-episode video
documentaries across a range of medical specialties for a physician
audience. The position encompasses a variety of pre-production,
production, and post-production responsibilities.
Pre-production responsibilities include researching potentially newsworthy topics in a
given medical condition, identification of key medical experts
appropriate to those topics to be interviewed for video documentary
series, outlining content to be covered in each episode for the series,
conducting pre-production phone interviews of patients and physicians to
hone topics to be covered in live shoot, working with a production
manager to schedule interviews of all individuals to be interviewed
during a given shoot.
Production responsibilities involve on-site
interviews with physicians and patients, on-site teamwork with the
production crew to capture all needed footage, including occasionally
impromptu interviews of medical staff.
Post-production responsibilities include providing video editors with papercuts of
transcripts from video shoots that detail the precise sequence of sound bites and B-roll choices for each episode of the series, working with video editors and Medscape TV executive editor to hone the final version of each episode.
While the position requires a level of
independence, all phases of work on a documentary series are subject to
oversight by the executive director and input from editorial directors,
as needed.
Appropriate work experience: 10 years' experience in
medical publishing (preferably text and video content) aimed at
physician audiences across a number of medical specialties, proven track
record in creating narrative video documentaries on medical topics
aimed at a medical audience.
Required Skills
A journalism background is preferred, as well as experience in developing
content for a medical professional audience. Candidates will need to be
able to write script outlines, research medical topics and identify
experts in the topic area.
Desired (not required) Skills:
Demonstrated storytelling ability; experience in video production; medical background
Education/Certifications:
College degree, with preference for journalism and science majors
Additional Information
If you are interested feel free to reach Ajay Kumar on #************ or email your resume on **********************
Easy ApplyGrant Researcher/Grant Writer
Medical writer job in Jersey City, NJ
Period of Performance: Part-time, maximum 30 hours per week, within a three-year contract term starting on or about January 1, 2026
Work Environment: Onsite work required on an as-needed basis
Citizenship Requirement: Must be a U.S. citizen
Company Overview:
About Enlightened: Enlightened is a leading provider of IT and federal program support services, committed to delivering innovative solutions and ensuring mission success.
Position Overview: Enlightened is seeking a highly motivated Grant Researcher / Grant Writer. The Grant Researcher / Grant Writer identifies, evaluates, and pursues grant opportunities that support the Port Authority's security initiatives. The role includes researching funding programs, coordinating with internal stakeholders, and preparing clear, compliant grant applications and supporting materials.
Key Responsibilities
Monitor and research federal, state, and other grant opportunities related to homeland security and critical infrastructure protection.
Analyze eligibility and requirements and advise leadership on which opportunities best fit agency needs.
Draft, organize, and edit grant applications, narratives, budgets, and required attachments, and coordinate reviews and approvals.
Support post-award activities, such as responding to funder questions, assisting with amendments, and preparing required progress documentation.
Required Qualifications:
Bachelor's degree, preferably in Accounting, Business, Finance, Public Administration, or five (5) years of comparable experience.
Strong research and writing skills, with experience in grant writing or grant program administration.
Familiarity with federal, state, or local grant processes, particularly homeland security-related programs such as UASI and general reimbursement programs.
Minimum of three (3) years of experience managing grant awards, including completing required financial reporting and monitoring project costs, schedules, and budgets.
Strong financial analysis, budgeting, and reporting skills, with experience in grant administration or grant-funded programs preferred.
Excellent organization and attention to detail, with the ability to manage multiple grants and deadlines.
Must be a U.S. citizen.
Support post-award activities, such as responding to funder questions, assisting with amendments, and preparing required progress documentation.
Benefits:
Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data.
At Enlightened, we pride ourselves on offering a comprehensive and industry-competitive benefits package to our full-time employees. Our benefits include:
Medical/Dental/Vision Insurance with Health Savings Accounts (HSA)
Flexible Spending Accounts (FSA)
401(k) Retirement Plan
Paid Holidays, Vacation, & Sick Leave
Professional Training & Development Reimbursement
Please note, these benefits are available exclusively to full-time employees of Enlightened.
Equal Opportunity Statement :
Enlightened is proud to be an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, disability, or any other federal, state, or local protected class.
Auto-ApplyEditor In Chief at Revolutionary Startup Social Enterprise
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.
Editor In Chief at Revolutionary Startup Social Enterprise
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.