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.
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 Princeton, NJ
The medical writer 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 medical writer in the pharmaceutical industry PhD with at least 1 year experience as a medical writer 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.
Auto-ApplyMedical Writer
Medical writer job in Princeton, NJ
The medical writer 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 medical writer in the pharmaceutical industry PhD with at least 1 year experience as a medical writer 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.
Medical Writer
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
Medical Writer/Content Specialist
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 degree or minor in a scientific discipline.
You are proficient in PowerPoint and Word, with excellent writing and editorial skills - an English degree or minor is a plus.
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
Auto-ApplyAssociate Medical Writer
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 Medical Writer 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 Medical Writer 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
Medical Writer
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
Medical 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 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, Global Regulatory Communication - Job ID: 1693
Medical writer job in Princeton, NJ
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
Travel: may be up to 10 days per year.
Requirements
You hold a relevant academic degree - preferably Master's level - and have experience within the pharma industry, and 8+ years within Medical Writing.
Furthermore, you have:
Experience in authoring clinical/regulatory documents.
Excellent verbal and written communication skills with the ability to effectively communicate with a variety of teams and individuals, across time zones.
Ability to understand, interpret and communicate data from clinical trials.
Proven ability to work with and lead cross-functional, global teams of contributors.
English at exceptional professional level, both written and spoken.
An interest in developing and improving medical writing-related processes.
As a person, you are a strong team player and proactive in nature, with a can-do attitude, and like to operate in an environment with opportunities to have high impact. You are comfortable working independently and can take decisions in complex situations.
As we are taking new steps towards developing best-in-class therapeutics for patients with rare diseases we are looking for people who possess an entrepreneurial mindset who can handle ambiguity, analyze, and create clarity and desires to be part of an organization where everything isn't set in stone.
The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere.
Salary range: $160-185k/year DOE
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Benefits
401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents
Auto-ApplyMedical Writer I
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
Medical Writer
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 Medical Writer 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.
Auto-ApplyMedical Writer
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 Medical Writer 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.
Auto-ApplySenior Medical Writer
Medical writer job in Yardley, PA
Overview / About us Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence.
Responsibilities / Position overview
We are seeking an advanced degree life-sciences professional to serve as a Senior Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.
The Senior Medical Writer will ensure high-quality content is developed for a wide range of medical communications projects and deliverables including clinical publications (manuscripts and abstracts), slide decks, scientific platforms, symposia, advisory boards, and training materials. In this role, the Senior Medical Writer has final sign-off authority and will review all deliverables on assigned accounts for technical accuracy, proper incorporation and interpretation of investigator/client data, and overall content and editorial quality. Experience supporting oncology publications accounts is highly desirable.
Qualifications
The ideal candidate will have an advanced degree in a life-sciences field, meticulous attention to detail and the ability to simultaneously work on multiple projects relating to multiple products in various therapeutic areas.
Additional Requirements and Qualifications
* PhD, PharmD, or MD
* 2+ years' experience in a healthcare communications agency environment or similar
* Outstanding writing, editing and communication skills and excellent command of the English language
* Exceptional attention to detail in relation to both scientific content and editorial standards
* Ability to adapt writing style to different materials and target audiences
* High level of proficiency with Microsoft Office applications (particularly Word and PowerPoint)
* Experience with referencing software and database searching desirable
Benefits
We offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance:
* Competitive salary plus bonus scheme
* Medical, dental, and vision insurance options
* 401(k) plan with employer match
* Generous amount of paid time off annually + 10 paid holidays
* Employee Assistance Program
* Company-paid short-term and long-term disability coverage
* Flexible spending accounts for health and dependent care and much more
* ----------------------------------------------------------------------------
#LI-Remote
#LI-Remote
Responsibilities We are seeking an advanced degree life-sciences professional to serve as a Senior Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges. The Senior Medical Writer will ensure high-quality content is developed for a wide range of medical communications projects and deliverables including clinical publications (manuscripts and abstracts), slide decks, scientific platforms, symposia, advisory boards, and training materials. In this role, the Senior Medical Writer has final sign-off authority and will review all deliverables on assigned accounts for technical accuracy, proper incorporation and interpretation of investigator/client data, and overall content and editorial quality. Experience supporting oncology publications accounts is highly desirable.
Auto-ApplySenior 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-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.
Medical Writer
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: Medical Writer
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.
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.