Medical writer jobs in Edison, NJ - 445 jobs

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

Insight Global is looking for a technical writer for one of our pharmaceutical clients to sit in Raritan, NJ. This candidate will revise and approve protocols, SOPs, and other equipment focused documentation. They will partner with the engineers, metrology, maintenance, calibration, and other facilities resources to determine the clearest and most logical way to present information to users. Our client has current templates within their Veeva Vault, Trackwise and Comet systems which contains content and workflows for candidates to pull protocols. REQUIRED SKILLS AND EXPERIENCE -5 years of experience in pharma -5 years experience with technical writing -Engineering knowledge -cGMP Manufacturing experience NICE TO HAVE SKILLS AND EXPERIENCE -Maximo CMMS experience -Veeva Vault, Comet, or Track wise

Job Title: Technical Writer Duration: 12+ Months Job Details: Must Have Skills Previous experience with SDLC and GLPGCP validation is preferred Technical writing or documentation experience in a regulated industry is preferred Experience with MS Office, specifically Word, Visio, and Excel, is required Detailed Job Description Previous experience with SDLC and GLPGCP validation is preferred Technical writing or documentation experience in a regulated industry is preferred. Bachelor's Degree in Computer Science or related field 8 to 12years of technical writing or documentation experience, preferably in a regulated industry Experience with MS Office, specifically Word, Visio, and Excel, is required Experience in life sciences or pharmaceuticals RD is preferred

The Director, Medical Writing will be an integral position working with the Clinical Development function to facilitate the translation of complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, the incumbent will lead the development of various documents that support our clinical trials, research/publications and regulatory activities. This role requires strong writing and communication skills to effectively convey complex clinical and scientific concepts in a clear and concise manner. Attention to detail and a commitment to producing accurate and high-quality written materials are essential. Proficiency with Microsoft Office Suite and familiarity with scientific writing tools are required. Knowledge of clinical research, regulatory requirements, and biotechnology are desired. Candidates need to be comfortable in a fast-paced and collaborative work environment and able to work effectively with cross-functional teams. Job Responsibilities Lead and execute on the creation of a wide range of medical and scientific documents, including briefing books, clinical study protocols, investigator brochures, regulatory submissions, and scientific publications. Collaborate closely with cross-functional teams to collect, interpret, and synthesize data, ensuring accuracy and relevance in written materials. Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards. Conduct comprehensive literature reviews to support the development of evidence-based documents. Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences. Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy. Contribute to the strategic planning and execution of medical writing projects to support research and development initiatives. Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines. Education and Experiences Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline). Proficiency in Microsoft Office Suite and familiarity with scientific writing tools. Demonstrated experience with regulatory submissions (IND, NDA) and a deep understanding of regulatory requirements and guidelines (FDA, EMA, ICH). Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research Technical Skills/Core Competencies Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally Strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner. Exceptional attention to detail and commitment to producing accurate and high-quality written materials. Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points Comfortable working in fast paced entrepreneurial environment Ability to travel up to 20% Salary Range: $170,000-185,000

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

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.

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.

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

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

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

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

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 ************

Job Title: Lead Medical Writer JOB PURPOSE Lead the medical writing team for accounts that require multiple writers to meet the content demands of customized medical communications initiatives, and/or lead multiple accounts. JOB RESPONSIBILITIES With minimal direction or supervision, responsible for assigned-client service: provide high-quality editorial oversight for all content including planning through review; maintain knowledge of project status (content development and review) to ensure editorial quality and successful completion of all client content projects; identify and develop new opportunities for projects (working with the account manager) and publications (working with the publications manager); interact with account manager, publications managers, and project managers to ensure adherence to timelines and deliverables. RESPONSIBILITY/PERFORMANCE MEASUREMENT Content Development Work closely with assigned project management team to ensure high-quality editorial implementation of all assigned-client programs. · Effectively provides the information people need to know to do their jobs and to feel good about being a member of the assigned-client project team · Provides medical writers information and direction so that they can draft accurate, high-quality editorial content; serves as a resource for questions · Assesses potential projects to provide an estimate of writing time required for completion · Reviews content for the assigned-client projects and ensures that content reflects clients' objectives and preferences while staying on time and on budget · Cultivates and shares expertise in assigned therapeutic areas · Delegates tasks and decisions in a professional manner, sets clear objectives, and trusts people to perform · Shares responsibility and accountability for assigned-client projects · Consistently complies with Fishawack standard editorial procedures, including ethical standards Communication Effectively and proactively communicate with team members (editorial, project, client), authors/faculty, and vendors in areas related to project completion. · Ensures that information is communicated effectively within and across internal teams in a timely manner · Keeps project team and manager apprised of project(s) status (through weekly status meetings or routine email communications) and challenges encountered during the project (eg, changes in scope, delays in receiving comments) to ensure project completion on time and on budget · Proactively provides input to team members to enhance project outcomes · Prioritizes workload for medical writers on team · Offers to assist others in times of slow workloads and asks for assistance during times of heavy workloads Business Development Investigate, conceptualize, and strategize new medical communications projects and publications to support the assigned-client's needs and opportunities. · Supports account manager's efforts to identify and secure new business for assigned client in a timely manner · Understands scope of Fishawack's capabilities and how to tailor Fishawack's services to assigned-client's needs · Effectively identifies opportunities for content development for assigned client Company Representation Represent the company at client meetings (eg, advisory boards, speaker-training meetings, business development initiatives) in a professional manner. · Serves as onsite editorial resource and content expert in a professional manner · Reviews and revises program content, as needed in an accurate and timely manner · Prepares speakers for their presentations in a professional manner · Anticipates additional onsite needs and proactively prepares for these needs · Proactively assists project team; acts as a collaborative team member · Is prepared to discuss topline information pertaining to content of business development meetings; educates internal, nonmedical team members about content-related issues REQUIRED KNOWLEDGE, SKILLS, & ABILITIES (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and ability required.) Education Required: 4 year post secondary education, or equivalent experience Bachelor's degree in the life sciences; PharmD or PhD highly preferred Experience 5+ years of medical writing experience; 5+ years of editorial process experience; 2+ years of experience with assigned-client's projects

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

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.

Flywheel (flywheelpartners.com) is a communications, education and training agency that supports leading healthcare companies by developing innovative medical and science educational resources - including but not limited to, eLearning modules, slide presentations, product brochures, backgrounders, videos, podcasts, learning games and skills development workshops. We partner with pharmaceutical, medical device, and biotech companies to drive enhanced clinical dialogue with healthcare providers, resulting in improved patient outcomes when using their products. We are critical thinkers who enjoy what we do. We value people who are entrepreneurial, low-maintenance, curious, and humble. And we're looking for people who fit that profile to help take our business to the next level. PRIMARY RESPONSIBILITIESCollaborate with a multi-functional account team to develop innovative medical and scientific educational materials tailored to our clients' needs. The audiences for whom we develop solutions are predominantly pharmaceutical sales forces, account managers, clinical educators, and medical affairs. This position provides the opportunity to gain entry to a healthcare agency from academics or related settings. Writing/Content Development Research, learn, and simplify complex scientific/medical information, ensuring it is clearly communicated to the target audience Reference check, proofread, and copy edit to ensure accuracy, clarity, and quality Client Relationships Consult with client project owners and subject matter experts (SMEs) to create engaging and effective educational content covering a broad range of topics-pharmaceutical drugs, medical and scientific information (ie, anatomy & physiology, disease state, diagnosis, treatment, marketplace), market access, the business of healthcare, and selling skills/soft skills Participate in scheduled status calls and client review meetings with Medical, Marketing, Sales, Legal, and Regulatory Develop expertise in client business, brands, and organizational structure Communicate clearly to client-based peers; help foster client relationships by building rapport and trust Professional Development Learn the Flywheel pathways for advancement within the Medical Writer track, or other roles based on interest and capabilities Take initiative to pursue development opportunities Be proactive and provide solutions DESIRED SKILLS AND EXPERIENCE Education + Experience Experience writing scientific / medical content in multimedia formats Advanced Degree (eg, MA, MS, PhD) in life sciences, healthcare, communications, journalism, or medical/scientific writing Client relationship experience is preferred Instructional design and visual design experience is preferred Skills Excellent communication (written and verbal), interpersonal, and presentation skills Superior organizational skills and exacting attention to detail and factual accuracy Referencing, proofreading, and copy editing skills High proficiency in Microsoft Word and PowerPoint, Google Suite, Adobe Acrobat, and scientific web research Ability to meet tight deadlines and manage multiple projects simultaneously Excellent time management skills and strong ability to meet tight deadlines and manage multiple projects simultaneously Ability to contribute and continuously adapt in a client environment where the one constant is “change” Disciplined self-starter who can manage focus, communication, and the necessary workload in a remote environment Salary Range: $80K - $85K per year. Flywheel Partners LLC. provides Equal Employment Opportunities to all employees and applicants for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, physical or mental disability, pregnancy, veteran or military status, genetic information, sexual orientation, gender identity or expression, marital status, civil union/domestic partnership status, familial status, domestic violence victim status, or any other legally recognized protected basis under federal, state or local laws. The Company complies with applicable federal, state and local laws governing nondiscrimination in employment in every location in which the company operates. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please inform the Associate Director, Operations if you need assistance completing this application or to otherwise participate in the application process. Privacy Policy: **************************************

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.

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.

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.