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.
$58k-75k yearly est. 2d ago
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Senior Medical Editor
Navisync 3.7
Senior copywriter job in Morristown, NJ
The Senior Editor will join a team of experienced editors and serve as lead on several client accounts. This person will ensure accuracy, consistency, and correct grammar, spelling, and punctuation in all client materials, as well as fact-check content to ensure accuracy and compliance with client submission requirements. The Senior Editor will serve as a resource for their brand teams on all matters of style and maintain style guides for assigned brands. This is a remote position with the option to work in the office.
NOTE: Only candidates in the NJ TriState area (NJ/NYC/Local PA) will be considered for this position.
Responsibilities:
Proofreads, copy edits, and fact-checks a variety of promotional materials, including but not limited to slide decks, print and digital brochures, flash cards, sales training materials, e-mails, and websites
Ensures correct grammar, spelling, usage, and adherence to AMA, agency, and client styles across projects
Maintains consistency in style, tone, and messaging across pieces
Validates accuracy of data and claims by thoroughly fact-checking references
Directs appropriate queries to project managers, writers, account directors, and other reviewers
Works with Project Management to ensure proper prioritization of projects and adherence to deadlines
Creates and maintains style guides for assigned brands and provides guidance to brand team on style
Participates in internal project kickoff, regroup, and status meetings for assigned brands
Assists other editors with work as needed
Qualifications and Experience
Bachelor's degree, preferably in English/Communications and/or equivalent work experience
5+ years of medical editing experience in an advertising agency
Thorough knowledge of AMA style
Proficiency in online routing, Microsoft Office, Adobe Acrobat, and PubMed/web searches; familiarity with Ziflow, Proof HQ, or similar program preferred
Superior organizational skills and attention to detail
Ability to multitask, prioritize, and work independently in a fast-paced, remote environment
High-level interpersonal and problem-solving skills
Should be a thoughtful, close reader, with a strong understanding of complex, technical material and be able to address issues of content flow, logic, and layout
Familiarity with market access preferred
$56k-79k yearly est. 3d ago
Fingerpaint Group Careers - Senior Copywriter
Finger Paint Marketing 3.2
Senior copywriter job in Cedarville, NJ
at Fingerpaint Marketing Reset your expectations of a health and wellness agency. From our inception, Fingerpaint has been driven by an unstoppable collective spirit of possibility. It's that curiosity that's at the heart of everything we do. From our legendary people-first culture to the hundreds of Fingerpainters who define us, we've reimagined what it means to be a healthcare and wellness advertising agency. Here, creativity happens naturally-we attract top talent and give them a space to grow and collaborate.
The Opportunity:
Hey there rising copy superstars, have we got an opportunity for you. As a seniorcopywriter, or a copywriter looking to the next step, you got the basics of the industry down. You're detailed oriented, proactive, and pretty stinking charming. You know how to write an email, annotate a CVA, and write a mean headline. But you're also hungry for more. If this sounds like you, we'd love to talk. This is your chance to grow on 2 long-standing brands with a legacy of producing award-winning work. 1 is DTP and 1 is HCP so you get to mix it up. Pretty cool.
The majority of your time will be spent working remotely. We do not have mandated days in an office. When we do get together live, it is about purposeful engagement. Specifically, going to clients for in person working sessions and reviews as well as occasional internal team meetings in our Cedar Knolls office that are designed to collaborate on specific projects and to drive team chemistry.
Core Function:
* Knowing what a great concept is when you create one
* Ability to think strategically, creatively and collaboratively
* Superior attention to detail; practiced use of a fine-toothed comb
* Natural curiosity about science and medicine
* Expertise in writing in multiple voices and styles
* Presentations that are as clear as your prose
* Knowledge of web and interactive content development/writing
* Graceful handling of multiple projects in a fast-paced environment
* Awareness that laughter really is the best medicine
Required:
* Pharma/healthcare advertising experience (3+ years)
Don't meet every single requirement? That's okay! Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Fingerpaint, we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your experience doesn't align perfectly, we encourage you to apply anyway. You may be just the right candidate for this or other roles! Our team of qualified recruiters can match you with the right opportunity. Fingerpaint Group provides equal employment [and affirmative action] opportunities to all applicants and employees. We are proud to recruit qualified applicants without regard to race, color, religion, gender, age, ethnic or national origin, protected veteran status, physical or mental disability, sexual orientation, gender identity, marital status, or citizenship status.
$73k-112k yearly est. Auto-Apply 3d ago
Senior Copywriter
Omnicom Health
Senior copywriter job in Hamilton, NJ
At DDB Health, we believe health can't wait. The pace of healthcare is accelerating-and we love it. That is why at DDB Health, we DARE TO DO BOLDLY. We believe there's nothing more important than health, and we need to stay a step ahead in order to achieve it. Our agency of courageous, curious, generous and gritty people is committed to solving the toughest health challenges. Through our omnichannel creative approach, we inspire our customers to take bold action that advances health.
Inclusivity:
We, at DDB Health, are an inclusive home. We believe that every voice matters, and we aim to reflect the world around us. Together, we can boldly tackle every health communication challenge with diverse thought and enhanced perspective.
Flexibility (new):
At DDBH we have a flexible hybrid working environment with employees able to split their time between the Soho headquarters and their home office, Friday afternoons free of meetings, Summer Fridays, and other perks and arrangements that enable our people to do their best work. We strive to be our boldest and best no matter where we are each doing our work - either with our clients, from home, or from the office.
DDB Health is a global network of healthcare communications companies dedicated to helping clients use creativity-and creative technology-as a force for good health. Through deep insight into customers, channels, and behavior, DDB Health creates meaningful change on behalf of important healthcare brands.
Title: SeniorCopywriter
Company/Location: DDB Health, New York City
Department/Discipline: Copy
Competencies: Creativity, Customer Focus, Interpersonal Savvy, Perseverance
Overview: you will have the opportunity to help create, present, and produce compelling, persuasive and original ideas for our current clients and for new business. This is terrific opportunity to help develop the content on digital and print platforms.
RESPONSIBILITIES:
Help develop content for a variety of print and digital projects, such as visual aids and websites
Understand the creative process and follow jobs from startup to completion
Contribute strategically to the long-term vision of the brand, internally and with the client
Develop understanding of basic marketing principles
Have up-to-date knowledge of all assigned brands and therapeutic indications, as well as understanding of the clients' marketplace
Help prepare and submit work for Medical/Legal/Regulatory review
Work closely with editors to ensure accuracy in all work; demonstrate ability to accurately reference and annotate work
Partner with account, art and editorial staff on assigned brands
Take direction from supervisor on projects; work independently as determined by supervisor
QUALIFICATIONS AND EXPERIENCE
Portfolio that demonstrates strong conceptual abilities and writing skills
2+ years of pharmaceutical and/or healthcare advertising, direct-to-physician
An ability to understand and process healthcare information
Bachelor's degree preferred
Demonstrated ability to write solid, intelligent, brand-appropriate, creative pieces in a variety of communication forms (eg, sales aid, direct mail) for a variety of audiences (eg, healthcare professionals, patients, consumers)
Strong creative ability, as shown in ads/other forms of communication, created in partnership with an art director
Excellent communication and presentation skills
The range below represents the low and high end of the base salary someone in this role may earn as an employee of an Omnicom Health Group company in the United States. Salaries will vary based on various factors including but not limited to professional and academic experience, training, associated responsibilities, and other business and organizational needs. The range listed is just one component of our total compensation package for employees. Salary decisions are dependent on the circumstances of each hire.
Salary range here - $70,000 - $99,500
Omnicom Health is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we're focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us-we look forward to getting to know you. We will process your personal data in accordance with our
Recruitment Privacy Notice
.
$70k-99.5k yearly Auto-Apply 14d ago
Managing Editor IEEE Climate (E5992)
IEEE 4.9
Senior copywriter job in Piscataway, NJ
The overall purpose of this position is to launch and ensure the success of IEEE Climate, an IEEE-wide, multidisciplinary, all-electronic archival magazine. The incumbent in this position is primarily responsible for developing and implementing long- and short-term content goals and also strategic and commercial marketing strategies for Climate. He or she must work effectively to provide solutions to issues and be proactive in researching how Climate may be more competitive in the publishing space. This position plays a key role in the success of the magazine through the achievement of usage, citation, and revenue generation goals. The role reports to the Senior Director, Publishing Operations, and works in concert with the Senior Director, under minimal supervision, to ensure the long-term financial health and stability of the journal. This postion requires a Master's or advanced degree Electrical Engineering, Computer Science, or a closely allied field of science or technology.
The Managing Editor of Climate is expected to guide the Editor-in-Chief (EIC) and the Editorial Board, recommending content best suited for the publication in order to achieve its goal of furthering the IEEE mission and vision by exploring the intersection of technology and climate change, specifically focusing on how IEEE technology can play a vital role in mitigating and adapting to climate change challenges. In support of that goal, the magazine will publish several types of content related to any aspect of climate change: original content of general interest, created by an expert editorial staff (including articles on policy related to, the social implications of, and the economic impact of technology related to climate change), expert insights in the form of mini reviews from field leaders on topics of significant interest, and cutting-edge technical articles describing original research. The broad scope of Climate will enable the inclusion of content that may be tangentially related to IEEE's fields of interest but that is critical to responding to a challenge as broad as climate change, such as discussions of public policy and the economic impact of climate change. The inclusion of multiple types of content will attract a wide range of authors writing on a variety of topics and will serve readers in need of climate-oriented content that they can use in their work.
Success is gauged by the quality of the content in the magazine, as indicated by a number of factors, including financial surplus, bibliometric indicators, and usage of the content. This position influences IEEE's revenues in several ways. First, timely and high-quality content is necessary for Climate to attract advertisers to generate revenue. Second, excellent content enhances the profile and popularity of the magazine, as well as provides high-quality content to IEEE Xplore, which generates substantial revenue for the IEEE. Finally, excellent content attracts the attention of experts, thought leaders, and other journalists and can lead to additional articles that reflect favorably upon the IEEE.
Key Responsibilities
* Functions as the Publishing Operations lead on the day-to-day operations of IEEE Climate, focusing on growing high-quality content and providing effective solutions and process improvements to reduce expense or decrease time to publication, and suggests ideas for new and increased revenue. Keeps up-to-date with trends in STM publishing to maintain awareness of changes and developments and anticipate their impact on the magazine.
* Collaborates with the EIC and Editorial Board in the strategic planning and execution of the Climate editorial program. This includes development and management of an editorial calendar, to include special issues as appropriate, and the creation of content for the magazine and website. Goal is to create 5 to 10 articles per issue, as needed, using a technical writer to explain a specific technology and ask respected practitioners for their perspective on the feasibility and potential impacts of the technology under discussion. In addition, solicits and acquires expert-authored articles as needed.
* Manages the peer review process and systems for Climate in accordance with PSPB's policies and processes that are defined by the Editorial Board, with the goal of reaching a publishing decision no more than eight weeks from initial submission, with accepted articles to be published in IEEE Xplore as Early Access upon acceptance.
* Reviews, critiques, and disposes of all contributed submissions in consultation with the editorial board and other subject matter experts within the IEEE.
* Guides authors, technical reviewers, technical writers, area editors, and guest editors in preparing material for publication.
* Writes Scanning the Issue for regular issues, Editorials, Publication Services and Products Board reports and miscellaneous documents subject to EIC review. Also creates all author/guest editor correspondence. Resolves author/guest editor problems and conflicts, as required.
* Oversees the design of front covers and the selection of appropriate advertising.
* Leads the creation, maintenance, and continuous improvement of the Climate website. Initiates and executes site redesigns, when necessary.
* Plans and executes annual IEEE Climate Editorial Board meetings.
* Recommends and influences the EIC in submitting new board member nominations to PSPB N&A and annually develops a confidential report on contributions of active board members.
* Recommends to the Senior Director, Publishing Operations, candidates for members of the Editorial Board or Editor-in-Chief.
* Works with IEEE's internal marketing group or other outside promotional organizations to develop a strategy and implements a plan to raise awareness of Climate. The purpose of the promotion is to increase subscriptions to and usage of the content, as well as to encourage technical submissions to the magazine.
* Interfaces with editorial production staff, marketing and sales staff, and other staff and volunteer organizations within and outside of IEEE.
* Conducts and analyzes reader surveys and presents results and recommendations to Editorial Board and Senior Director, Publishing Operations. These surveys should be conducted approximately every five years, and should serve as the basis for recommending changes to the design, format, content, or new product models for Climate.
* Works with the Senior Director, Publishing Operations, to develop an annual financial budget and periodic forecasts for the publication.
* Takes on responsibility for the management of additional publication products, as assigned.
Travel Information
* 10 -15% Domestic and International
Educatio
* Master's or other advanced degree Electrical Engineering, Computer Science, or a closely allied field of science or technology Req
Work Experience
* 10-15 years Experience in a technical publishing leadership role, specifically in periodical publishing, and subject matter knowledge of electrical engineering theory, applications and professional practices Req
Skills and Requirements
* A solid and diverse understanding of the interrelationships and trends of state-of-the-art developments in electrical and computer technology is desired. Insight into corporate, academic and research lab roles in engineering progress is preferred.Must have excellent leadership and interpersonal skills Must have excellent verbal and written communication skills Must have extensive experience in publication planning, and scheduling, and knowledge of the periodical publication process.Able to liaise effectively with stakeholders in different departments and balance editorial consensus of the Editorial Board with the best business interests of the IEEE is necessary. He/She must be a technologically savvy knowledge worker who seeks out technology solutions to business challenges.Specific technology knowledge and experience needed to produce the desired outcomes include the following: knowledge of online peer review systems, such as ScholarOne Manuscripts or Aries Editorial Manager, proficiency in Microsoft Office products, such as Word, Excel and PowerPoint, and knowledge of the technology used to produce best-in-class websites.
Other Requirements:
As defined in IEEE Policies, individuals currently serving on an IEEE board or committee are not eligible to apply.
PLEASE NOTE: This position is not budgeted for employer-sponsored immigration support, this includes all persons in F (both CPT and OPT), J, H, L, or O status.
For information on work demands and conditions required for this position, please consult the reference document, ADA Requirements. This position is classified under Category I - Office Positions.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
===============================================
Disclaimer: This is proprietary to IEEE. It outlines the general nature and key features performed by various positions that share the same job classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties and qualifications required of all employees assigned to the job. Nothing in this job description restricts management's right to assign or re-assign duties to this job at any time due to reasonable accommodations or other business reasons.
$88k-126k yearly est. 60d+ ago
Medical Writer
Artech Information System 4.8
Senior copywriter job in New Jersey
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
************
$79k-110k yearly est. 14h ago
Senior Technical Writer
Buzzclan
Senior copywriter job in New Jersey
Buzz Clan is a business consulting company collaborating to provide Oracle and other software advisory services & implementation Services specialists by our Public & Private sector clients. We have been catering to wide-ranging technologies and platforms and have consistently been delivering the best available talent to Fortune 500 clients across different industry verticals and public sector clients of North America.
I would like to discuss the opportunity with you. Please go through the job description and let me know if you are interested in applying for this position.
Additional Information
All your information will be kept confidential according to EEO guidelines.
$60k-80k yearly est. 14h ago
Medical Writer
Systimmune, Inc.
Senior copywriter 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.
$80k-130k yearly 21d ago
Sr. Technical Writer
Evtks
Senior copywriter job in New Jersey
As a Technical Writer, you will work with the Federal NOTAM System (FNS) team to provide first level documentation, recommendations, and new documentation to FNS first level support; documentation includes technical instruction books, handbook, and other technical directives.
Responsibilities:
Possess a technical understanding of the maintenance of NAS (National Airspace System)
Review technical documentation and provide recommendations for improvements
Track and audit documentation redlines
Support system development/testing/integration/deployment activities
Develop and manage system engineering, requirements, and testing artifacts and required baseline artifacts
Must be willing to travel
Qualifications:
Associates degree and ten (10) years of related work experience OR
Bachelor's degree with a minimum of eight (8) years of related work experience
Technical Proficiencies
Required
Experience in developing NAS technical documentation and second level engineering
Proficient technical writing and oral communication skills
Preferred
Experience in system test
Analytical and problem-solving ability
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position. This description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this job. Management retains the discretion to add or change the duties of the position at any time.
#AFHC-24521
Compensation: $65,000.00 - $70,000.00 per year
EVTKS is a minority veteran-owned small business that provides our customers with the most qualified professionals for their endeavors.
Since 2011, EVTKS has been involved in leadership and development. We are proud to lead the way towards a more efficient future with innovative ideas, game-changing technology and polished engineering solutions. We are passionate about connecting people and transforming needs into solutions.
$65k-70k yearly Auto-Apply 60d+ ago
Medical Writer
Cs&S Staffing Solutions
Senior copywriter job in Princeton, NJ
Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx *You can apply through Indeed using mobile devices with this link.
Additional Information
$77k-116k yearly est. 14h ago
Associate Medical Writer
Bioclinica
Senior copywriter 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
$77k-116k yearly est. 14h ago
Medical Writer I, II or III
Mitsubishi Tanabe Pharma 4.1
Senior copywriter 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
$77k-110k yearly est. Auto-Apply 60d+ ago
Medical Writer I
Lancesoft 4.5
Senior copywriter 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
Job Description:
Write technical materials, such as SOP's, appendices
Additional Information
Duties and Responsibilities:
• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.
• Maintain records and files of work and revisions
• Edit, standardize, or make changes to material prepared by other writers or establishment personnel
• 2+ years experience as a Technical Writer
• 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team
• Proofing/preparation of documentation
$82k-112k yearly est. 14h ago
Medical Writer
MJH Life Sciences Multimedia Medical LLC
Senior copywriter 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.
$55k-60k yearly Auto-Apply 60d+ ago
Editor In Chief at Revolutionary Startup Social Enterprise
Iflip4
Senior copywriter 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.
$48k-77k yearly est. 14h ago
Medical Writer
Allen Spolden
Senior copywriter 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.
$60 hourly 60d+ ago
Senior Copywriter
Fingerpaint 3.2
Senior copywriter job in Cedarville, NJ
at Fingerpaint Marketing
Reset your expectations of a health and wellness agency. From our inception, Fingerpaint has been driven by an unstoppable collective spirit of possibility. It's that curiosity that's at the heart of everything we do. From our legendary people-first culture to the hundreds of Fingerpainters who define us, we've reimagined what it means to be a healthcare and wellness advertising agency. Here, creativity happens naturally-we attract top talent and give them a space to grow and collaborate. The Opportunity: Hey there rising copy superstars, have we got an opportunity for you. As a seniorcopywriter, or a copywriter looking to the next step, you got the basics of the industry down. You're detailed oriented, proactive, and pretty stinking charming. You know how to write an email, annotate a CVA, and write a mean headline. But you're also hungry for more. If this sounds like you, we'd love to talk. This is your chance to grow on 2 long-standing brands with a legacy of producing award-winning work. 1 is DTP and 1 is HCP so you get to mix it up. Pretty cool. The majority of your time will be spent working remotely. We do not have mandated days in an office. When we do get together live, it is about purposeful engagement. Specifically, going to clients for in person working sessions and reviews as well as occasional internal team meetings in our Cedar Knolls office that are designed to collaborate on specific projects and to drive team chemistry. Core Function:
Knowing what a great concept is when you create one
Ability to think strategically, creatively and collaboratively
Superior attention to detail; practiced use of a fine-toothed comb
Natural curiosity about science and medicine
Expertise in writing in multiple voices and styles
Presentations that are as clear as your prose
Knowledge of web and interactive content development/writing
Graceful handling of multiple projects in a fast-paced environment
Awareness that laughter really is the best medicine
Required:
Pharma/healthcare advertising experience (3+ years)
Don't meet every single requirement? That's okay! Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Fingerpaint, we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your experience doesn't align perfectly, we encourage you to apply anyway. You may be just the right candidate for this or other roles! Our team of qualified recruiters can match you with the right opportunity. Fingerpaint Group provides equal employment [and affirmative action] opportunities to all applicants and employees. We are proud to recruit qualified applicants without regard to race, color, religion, gender, age, ethnic or national origin, protected veteran status, physical or mental disability, sexual orientation, gender identity, marital status, or citizenship status.
$73k-112k yearly est. Auto-Apply 60d+ ago
Managing Editor IEEE Climate (E5992)
Ieee 4.9
Senior copywriter job in Piscataway, NJ
Managing Editor IEEE Climate (E5992) - 250244: KNW-D70 Description Job Summary The overall purpose of this position is to launch and ensure the success of IEEE Climate, an IEEE-wide, multidisciplinary, all-electronic archival magazine. The incumbent in this position is primarily responsible for developing and implementing long- and short-term content goals and also strategic and commercial marketing strategies for Climate.
He or she must work effectively to provide solutions to issues and be proactive in researching how Climate may be more competitive in the publishing space.
This position plays a key role in the success of the magazine through the achievement of usage, citation, and revenue generation goals.
The role reports to the Senior Director, Publishing Operations, and works in concert with the Senior Director, under minimal supervision, to ensure the long-term financial health and stability of the journal.
This postion requires a Master's or advanced degree Electrical Engineering, Computer Science, or a closely allied field of science or technology.
The Managing Editor of Climate is expected to guide the Editor-in-Chief (EIC) and the Editorial Board, recommending content best suited for the publication in order to achieve its goal of furthering the IEEE mission and vision by exploring the intersection of technology and climate change, specifically focusing on how IEEE technology can play a vital role in mitigating and adapting to climate change challenges.
In support of that goal, the magazine will publish several types of content related to any aspect of climate change: original content of general interest, created by an expert editorial staff (including articles on policy related to, the social implications of, and the economic impact of technology related to climate change), expert insights in the form of mini reviews from field leaders on topics of significant interest, and cutting-edge technical articles describing original research.
The broad scope of Climate will enable the inclusion of content that may be tangentially related to IEEE's fields of interest but that is critical to responding to a challenge as broad as climate change, such as discussions of public policy and the economic impact of climate change.
The inclusion of multiple types of content will attract a wide range of authors writing on a variety of topics and will serve readers in need of climate-oriented content that they can use in their work.
Success is gauged by the quality of the content in the magazine, as indicated by a number of factors, including financial surplus, bibliometric indicators, and usage of the content.
This position influences IEEE's revenues in several ways.
First, timely and high-quality content is necessary for Climate to attract advertisers to generate revenue.
Second, excellent content enhances the profile and popularity of the magazine, as well as provides high-quality content to IEEE Xplore, which generates substantial revenue for the IEEE.
Finally, excellent content attracts the attention of experts, thought leaders, and other journalists and can lead to additional articles that reflect favorably upon the IEEE.
Key Responsibilities Functions as the Publishing Operations lead on the day-to-day operations of IEEE Climate, focusing on growing high-quality content and providing effective solutions and process improvements to reduce expense or decrease time to publication, and suggests ideas for new and increased revenue.
Keeps up-to-date with trends in STM publishing to maintain awareness of changes and developments and anticipate their impact on the magazine.
Collaborates with the EIC and Editorial Board in the strategic planning and execution of the Climate editorial program.
This includes development and management of an editorial calendar, to include special issues as appropriate, and the creation of content for the magazine and website.
Goal is to create 5 to 10 articles per issue, as needed, using a technical writer to explain a specific technology and ask respected practitioners for their perspective on the feasibility and potential impacts of the technology under discussion.
In addition, solicits and acquires expert-authored articles as needed.
Manages the peer review process and systems for Climate in accordance with PSPB's policies and processes that are defined by the Editorial Board, with the goal of reaching a publishing decision no more than eight weeks from initial submission, with accepted articles to be published in IEEE Xplore as Early Access upon acceptance.
Reviews, critiques, and disposes of all contributed submissions in consultation with the editorial board and other subject matter experts within the IEEE.
Guides authors, technical reviewers, technical writers, area editors, and guest editors in preparing material for publication.
Writes Scanning the Issue for regular issues, Editorials, Publication Services and Products Board reports and miscellaneous documents subject to EIC review.
Also creates all author/guest editor correspondence.
Resolves author/guest editor problems and conflicts, as required.
Oversees the design of front covers and the selection of appropriate advertising.
Leads the creation, maintenance, and continuous improvement of the Climate website.
Initiates and executes site redesigns, when necessary.
Plans and executes annual IEEE Climate Editorial Board meetings.
Recommends and influences the EIC in submitting new board member nominations to PSPB N&A and annually develops a confidential report on contributions of active board members.
Recommends to the Senior Director, Publishing Operations, candidates for members of the Editorial Board or Editor-in-Chief.
Works with IEEE's internal marketing group or other outside promotional organizations to develop a strategy and implements a plan to raise awareness of Climate.
The purpose of the promotion is to increase subscriptions to and usage of the content, as well as to encourage technical submissions to the magazine.
Interfaces with editorial production staff, marketing and sales staff, and other staff and volunteer organizations within and outside of IEEE.
Conducts and analyzes reader surveys and presents results and recommendations to Editorial Board and Senior Director, Publishing Operations.
These surveys should be conducted approximately every five years, and should serve as the basis for recommending changes to the design, format, content, or new product models for Climate.
Works with the Senior Director, Publishing Operations, to develop an annual financial budget and periodic forecasts for the publication.
Takes on responsibility for the management of additional publication products, as assigned.
Travel Information 10 -15% Domestic and International Qualifications Educatio Master's or other advanced degree Electrical Engineering, Computer Science, or a closely allied field of science or technology ReqWork Experience 10-15 years Experience in a technical publishing leadership role, specifically in periodical publishing, and subject matter knowledge of electrical engineering theory, applications and professional practices ReqSkills and Requirements A solid and diverse understanding of the interrelationships and trends of state-of-the-art developments in electrical and computer technology is desired.
Insight into corporate, academic and research lab roles in engineering progress is preferred.
Must have excellent leadership and interpersonal skills Must have excellent verbal and written communication skills Must have extensive experience in publication planning, and scheduling, and knowledge of the periodical publication process.
Able to liaise effectively with stakeholders in different departments and balance editorial consensus of the Editorial Board with the best business interests of the IEEE is necessary.
He/She must be a technologically savvy knowledge worker who seeks out technology solutions to business challenges.
Specific technology knowledge and experience needed to produce the desired outcomes include the following: knowledge of online peer review systems, such as ScholarOne Manuscripts or Aries Editorial Manager, proficiency in Microsoft Office products, such as Word, Excel and PowerPoint, and knowledge of the technology used to produce best-in-class websites.
Other Requirements:As defined in IEEE Policies, individuals currently serving on an IEEE board or committee are not eligible to apply.
PLEASE NOTE: This position is not budgeted for employer-sponsored immigration support, this includes all persons in F (both CPT and OPT), J, H, L, or O status.
For information on work demands and conditions required for this position, please consult the reference document, ADA Requirements.
This position is classified under Category I - Office Positions.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
===============================================Disclaimer: This is proprietary to IEEE.
It outlines the general nature and key features performed by various positions that share the same job classification.
It is not designed to contain or be interpreted as a comprehensive inventory of all duties and qualifications required of all employees assigned to the job.
Nothing in this job description restricts management's right to assign or re-assign duties to this job at any time due to reasonable accommodations or other business reasons.
Min: 138,000 Max: 172,000 Job: Publications Primary Location: United States-New Jersey-Piscataway Schedule: Full-time Job Type: Regular Job Posting: Aug 19, 2025, 1:06:15 PM
$88k-126k yearly est. Auto-Apply 1h ago
Medical Writer
Artech Information System 4.8
Senior copywriter 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.
$79k-111k yearly est. 14h ago
Editor In Chief at Revolutionary Startup Social Enterprise
Iflip4
Senior copywriter 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.