Medical writer jobs in Plainfield, NJ

ABOUT US Sanctuary for Families is New York's leading service provider and advocate for survivors of domestic violence, sex trafficking and related forms of gender violence. Every year, Sanctuary empowers thousands of adults and children to move from fear and abuse to safety and stability, transforming lives through a comprehensive range of services. We provide a range of wrap-around services to help survivors rebuild their lives in the aftermath of abuse, and work to end gender violence through three key strategies: direct services, outreach and training, and systems-change advocacy. Our services are available in 12 locations throughout New York City. POSITION OVERVIEW The Grants Specialist is responsible for overseeing their own portfolio of Foundation and Corporate funders and will support the other Institutional Giving team members in writing and submitting high quality report and proposal packages. In addition, this individual will have primary responsibility for crucial team functions such as financial reporting, deadline tracking, and preparing applications in response to government RFPs, including liaising with many external partners to establish and document partnerships. RESPONSIBILITIES Manage a portfolio of 10-20 foundation & corporate funders, including preparing high-quality reports and proposals and cultivating relationships through regular stewardship Implement moves management best practices to drive strategic growth of Institutional portfolio Prepare reports and proposals for the broader Institutional Giving Team private portfolio of 60 private funders, including writing, project planning, information gathering and key attachments Oversee the financial tracking and reporting of the $4M Institutional Giving portfolio, including monthly reconciliation within the Development Department and quarterly financial forecasts and cash flow reports to the Finance Department Assist with preparing and submitting government funding applications in response to Request for Proposals (RFPs) issued by relevant City, State, and Federal agencies. This includes drafting narrative as well as project management, creating timelines, preparing and compiling attachments, and coordinating with staff across the agency as well as external partners (nonprofit and governmental) to ensure timely submission. Manage the Institutional Giving calendar of proposal and reporting deadlines to ensure timely submission and appropriate follow-up for current funders and new prospects. This may include creating new procedures and strategic use of project management tools. Oversee grant awards processing, including recording pledges/awards, revenue received, and generating timely acknowledgement letters Conduct prospect research: identifying new funding prospects and RFPs; preparing reports and making recommendations on promising donors; and maintaining organized research files Liaise with Sanctuary program, data/evaluation, and finance staff to gather information for proposals and reports Assist the team as needed to ensure meticulous, complete proposal and report packages Thoroughly document proposal/report submission, donor cultivation notes, etc. in Raiser's Edge database Other Responsibilities Perform any other department or agency-related duties or special projects as needed Work closely with all members of the 13-person Development & Communications Department to ensure synergy in fundraising efforts Support communication with Board of Directors, private foundations, corporations, elected officials, and community partners Management Responsibilities Support Senior Manager of Institutional Giving in coordinating summer interns & other volunteers as needed Organizational Relationships: This individual will need to interface with internal and external stakeholders at all levels of the Sanctuary organizational chart In particular, this individual will work most closely with the Development team, Contract Management/Finance teams, and Data, Impact, & Evaluation Team This position will regularly meet with and request information from direct program staff agency wide (particularly for programs that have higher percentages of private funding) Importantly, the Grants Specialist will also need to interact regularly with agency Executive and Senior leadership This role will also require occasionally communicating with members of the Board of Directors as well as key donors and Sanctuary stakeholders The Grants Specialist will also be equipped with knowledge of government grants and contracts to meet with public officials such as City Council members and staff, concerning funding requests Education, Training, and Experience Bachelor's degree or relevant work experience required Minimum 2-4 years of nonprofit experience preferred, ideally in a development role Knowledge and Skills Excellent organizational skills and attention to detail Exceptional writing and proofreading skills Familiarity with nonprofit fundraising Basic knowledge of nonprofit budgeting, including how to analyze a budget Familiarity with researching institutional funders and key criteria for identifying strong prospects Research and analytical skills Ability to multi-task, prioritize effectively, and meet competing deadlines Ability to work independently Strong interpersonal skills, judgment, diplomacy, and ability to interact in a professional manner with a wide range of internal and external collaborators at all levels Creativity and comfort with proposing new ideas Proficiency in Microsoft Office Suite Familiarity with Raiser's Edge NXT and/or fundraising CRMs Knowledge and/or interest in learning about gender-based violence, trauma, poverty, human services, and advocacy Commitment to social justice and the mission and goals of Sanctuary for Families Budgeted Salary: Annualized base salary $61,509 - $ 67,945 per year ($33.80 - $37.33 per hour); based on experience pursuant to wage scale in accordance with collective bargaining agreement Work position is Full-time (standard 35 hours/week); Hourly/Non-Exempt Work schedule is currently hybrid; must be able to meet job location schedule obligations Benefits: Health, Dental and Vision Insurance Employer-paid life insurance Employer retirement contribution Paid time off (Holidays, Vacation, Personal, Sick) Generous Leave Policy Flexible spending account / Health savings account Student loan assistance Tuition reimbursement program Gym reimbursement program Wellness program and rewards Sanctuary for Families is a welcoming workplace. All qualified applicants will be afforded equal employment opportunities without discrimination because of race, creed (religion), color, sex, national origin, sexual orientation, military status, age, disability, predisposing genetic characteristics, marital status or domestic violence victim status, and other categories protected under Federal, New York state or New York city laws. Survivors of gender-based violence are strongly encouraged to apply.

We seek an experienced, detail-oriented Content Editor to join our content team at iQuanti. The Content Editor will be responsible for reviewing and editing content across various client projects, ensuring the highest quality standards, accuracy, and alignment with client specifications. This role will require expertise in the BFSI (Banking, Financial Services, and Insurance) sector, with the ability to review and refine content in multiple formats. As a key part of our content team, the Content Editor will work closely with writers to provide clear, actionable feedback and ensure that all content meets or exceeds iQuanti's editorial standards while aligning with client expectations and brand guidelines. The ideal candidate will have a sharp eye for detail, strong editorial skills, and a deep understanding of communicating complex financial topics clearly and engagingly. Key Responsibilities: 1. Content Review & Editing • Review and edit a wide variety of content types, including blog posts, rich media assets, video scripts, and website copy. • Ensure content is grammatically correct, free from spelling or typographical errors, and adheres to iQuanti's editorial standards. • Line edit to focus on structure, flow, clarity, and conciseness while maintaining the content's original intent. 2. Fact-Checking & Accuracy • Fact-check all content to ensure accuracy, including verifying statistics, data, quotes, and other factual claims. • Ensure sources are credible, up-to-date, and meet the client's approval criteria. • Collaborate with writers to resolve any discrepancies or inaccuracies in content. 3. Client Alignment & Brand Consistency • Ensure all content aligns with client expectations, style guides, and feedback. • Maintain strong communication with clients (via account managers or directly) to clarify expectations and incorporate feedback into content revisions. • Adapt content to suit different clients' specific industry requirements, particularly in the BFSI sector. 4. Content Feedback & Writer Development • Provide writers with constructive, clear, and actionable feedback to help them improve their skills and ensure content quality. • Collaborate with the content team to address recurring writing issues or content trends that need improvement. • Assist in onboarding and mentoring junior writers, offering insights into industry best practices and writing techniques. 5. Quality Assurance • Ensure that all content that is produced meets iQuanti's high editorial and quality standards. • Review content for consistency and ensure it aligns with SEO best practices where applicable. • Perform additional quality checks as needed, ensuring final deliverables are polished and ready for client review or publication. Preferred Qualifications: • 3-5 years experience editing content in the BFSI (Banking, Financial Services, and Insurance) sector. • Strong background in editorial roles, with a proven ability to work across various content formats. • Exceptional attention to detail, with the ability to catch grammar, spelling, and factual errors. • Strong knowledge of SEO best practices and how they apply to content creation and editing. • Ability to adapt to different client voices, preferences, and brand guidelines. • Excellent communication skills, with experience providing clear and constructive feedback to writers. • Familiarity with content management systems (CMS) and project management tools is a plus. • Bachelor's degree in English, Journalism, Communications, or related field (or equivalent experience). Salary - $60K - $70K

Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Principal Medical Writer at Compass Pathways is responsible for developing various clinical regulatory documents related to our investigational product, our proprietary psilocybin therapy. This person leads document preparation, ensures adherence to regulatory and company standards, coordinates outsourced writing services, and collaborates with multidisciplinary teams to support the regulatory sciences function. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Associate Director, Medical Writing. Roles and responsibilities Responsibilities include (but are not limited to): Leads preparation of clinical regulatory documents, including CSRs, protocols, IB and clinical summaries (Module 2.7.x and ISE/ISS) Ensures Compass clinical documents are clear, accurate, and written in accordance with the relevant guidance and best practice Oversees and co-ordinates outsourced medical writing services as required. Provides subject matter expertise as a member of the regulatory sciences team Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System; ensuring participant safety, data integrity and accuracy throughout the trial process Candidate profile: Minimally a Bachelor's degree in the life or health sciences; MSc or PhD preferred Considerable experience in regulatory medical writing within the pharmaceutical/medical industry/CRO Experience in leading the development of clinical documents as part of a multi‑functional team, including CSRs, IBs, clinical summaries, ISS/ISE) Broad working knowledge of the clinical drug development process with experience of integrating information into clinical regulatory documents Knowledge of relevant ICH guidance relating to clinical regulatory documentation Excellent written English with aptitude for clear and concise writing. Excellent attention to detail and editorial skills Flexibility in adapting to changing circumstances or new information Alignment to our company culture and values 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$160,000-$205,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

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

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. This is Direct Hire Position with one of our Clients Job Description- • The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. • This will be achieved by applying analytical skills, functional literacy and expertise in document preparation. • The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, REMS, key sections of the Investigator's Brochure, the Annual Safety Report and regulatory briefing documents. • Individual will create and foster an environment of partnership with other members of product teams, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors. RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Author documents such as agency briefing documents, key sections of the Investigator's Brochure, the Annual Safety Report and the core data sheet. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables). • Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management. • Serve as the point of contact (“go to” person) for one or more projects or products. • Organize and lead a MD matrix team of authors to deliver all MDL deliverables for each assigned project. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents Technical Skill Requirements: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to think creatively and to develop strategic plans that demonstrate sound judgment. • Exhibits sound project management and time management skills. • Able to interact effectively with all levels/roles of project team members. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise. • Is able to implement systems and processes and suggest process improvements. • Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines. • • Able to complete and turn around high quality outputs with only minimal guidance from management Qualifications • Scientific/medical academic background (e.g. PharmD/PhD or MSc/BSc with experience), or equivalent. • BS degree and 1 or more years of pharmaceutical experience preferred. • An advanced degree preferred and at least 3 years medical writing experience and /or experience in pharmaceutical development. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and non-scientific audiences. • Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. • Able to clearly articulate scientific and clinical data in all written and verbal communication. • May include a track record of leadership abilities either as a direct supervisor or within a matrix setting Additional Information

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

Job Description 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 Powered by JazzHR 2cmcHDJaIx

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

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.

We are currently looking for freelance medical writers for one of our esteemed client and this opportunity will primarily involve writing case reports and will sometimes include a mix of both editing and developmental writing. Apply here : ***************************************************************** The primary responsibilities are listed below: Position: Medical Writer Basic requirements: Experience in writing manuscripts. Primary responsibilities: · You will have to work with clients to understand the nature of the scientific work that they will be covering. You will have to assess the case using your medical expertise and also be open to developing expertise in new areas of writing · You will have to compile, write, and edit medical writing deliverables covering all phases of research for submission to journals/regulatory agencies · You must be well versed with all the major style guides (e.g., AMA, APA, CSE) · You must have good knowledge of ICH GCP, ISMPP, CONSORT, COPE, and/or ICMJE guidelines · Be adept at doing literature review · Reliability, flexibility, and responsiveness · Expertise and diligence in handling deadlines A glimpse at what you would edit: You will be assigned theses/dissertations of varying difficulty levels (in terms of original English level, subject matter expertise, and the extent of revision needed), written by native and non-native speakers. These will be primarily written by graduate/masters/PhD students pursuing their diplomas/degrees/doctorates. The thesis editor's role is to proofread/edit their theses/dissertations to ensure successful submission and to provide suggestions/critique to improve their academic writing skills. You should ensure: Immaculate grammar, punctuation, sentence structure, and word choice Flow, transition, and coherence Preservation of the author's intended meaning Application of academic editing conventions and style (e.g., citation style, layout, section headings, and tense usage) When requested by our clients, formatting of theses/dissertations according to the guidelines provided by the institution/style guide (basic familiarity with style guides such as AMA, APA, MLA, and CMOS will be preferred). Enago will ensure Possibility of a guaranteed monthly income while freelancing: Apart from offering work in the typical freelancing manner, we also offer opportunities that guarantee a minimum monthly/annual income, along with the possibility of an additional annual bonus (monetary), based on your performance. Our fees are decided as per a pricing grid that takes into account different factors such as qualification, years of relevant experience, industry standards, etc. Most importantly it is decided after an applicant edits a doctored editing sample test. A smooth performance-driven progression curve with an effective feedback mechanism: This ensures that the expectation mismatch is nearly zero. In the past, the strong professional bonding with our freelance editors has also led to mutual recommendations-a definite plus factor! A rewarding experience, both monetarily and intellectually: You will get the opportunity to apply your domain knowledge and skills to help non-native authors present their work to the academia. Additional Information All your information will be kept confidential according to EEO guidelines.

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

United by one profound purpose: to reach EVERY PATIENT POSSIBLE. At Avalere Health, we ensure every patient is identified, treated, supported, and cared for. Equally. Our Advisory, Medical, and Marketing teams come together - powerfully and intentionally - to forge unconventional connections, building a future where healthcare is not a barrier and no patient is left behind. Achieving our mission starts with providing enriching, purpose-driven careers for our team that empower them to make a tangible impact on patient lives. We are committed to creating a culture where our employees are empowered to bring their whole selves to work and tap into the power of diverse backgrounds and skillsets to play a part in making a difference for every patient, everywhere. Our flexible approach to working allows our global teams to decide where they want to work, whether in-office or at home based on team and client need. Major city hubs in London, Manchester, Washington, D.C., and New York, and smaller offices globally, serve as collaboration hubs allowing our teams to come together when it matters. Homeworkers are equally supported, with dedicated social opportunities and resources. Our inclusive culture is at the heart of everything we do. We proudly support our employees in bringing their whole selves to work with our six Employee Network Groups - Diverse Ability, Family, Gender, LGBTQ+, Mental Health, and Race/Ethnicity. These groups provide opportunities to promote diversity, equity, and inclusion and to connect, learn, and socialise through regular meetings and programs of activity. We are an accredited Fertility Friendly employer with our Fertility Policy, enhanced parental leave, and culture of flexibility ensuring every employee feels supported across their family planning journey and can work in a way that suits their family's needs. We are deeply invested in supporting professional growth for our employees through day-to-day career experiences, access to thousands of on-demand training sessions, regular career conversations, and the opportunity for global, cross-capability career moves. We take pride in being part of the Disability Confident Scheme. This helps make sure you can be interviewed fairly if you have a disability, long term health condition, or are neurodiverse. If you'd like to apply and need adjustments made, you can let us know in your application. Location: This position will ideally be based on the East Coast of the United States; however, candidates from other locations in the United States such as Central may be considered based on qualifications and experience. Start Date: January 2026 About the role As a Medical Writer within the Medical capability at Avalere Health, you will be responsible for delivering high-quality content, including manuscripts, posters, abstracts, slides, and other materials, all while adhering to project specifications, timelines, and budgets. You'll need to quickly grasp and synthesize complex information from unfamiliar therapy areas to create impactful materials within strict deadlines and scope. You will join the Scientific Services team, the engine of Avalere Health's Medical capability. In this role, you'll collaborate with clients to cut through the noise of data, extract valuable insights, and work with external experts to develop engaging strategies and compelling solutions that ultimately improve patients' lives.What you'll do Research, write, and revise, high-quality, original editorial content across a range of project types (i.e. manuscripts, posters, abstracts, slide decks). Assess projects to proactively identify areas that will require team collaboration (i.e. creative design, editorial support); and elicit help as needed. Liaise with clients, authors, speakers, and colleagues with professionalism and confidence, always being on top of their projects. Orchestrate multiple activities at once to accomplish a goal; juggling multiple project types and deadlines by using time efficiently. Work with internal account teams to ensure projects are always delivered on time and on budget. About you BSc or higher degree in the life sciences; a masters or PhD may be desirable but is not required. Exceptional verbal and written communication skills. Proficiency in the use of MS Office. Proficiency in internet and PubMed searches. $70,000 - $90,000 a year Salary is DOE What we can offer You will receive a 401K plan with an employer match contribution up to 4% (immediately vested), as well as life insurance, disability coverage, and medical, dental, and vision plans for peace of mind. Enjoy flexible working arrangements, including hybrid and remote work, along with the option to work from anywhere across the globe two weeks each year. We provide 20 vacation days plus one personal well-being day, recognise 9 public holidays, along with gifted end-of-year holidays and an early Summer Friday finish in June, July, and August. Access free counselling through our employee assistance program and personalized health support. Our enhanced maternity, paternity, family leave, and fertility policies provide support across every stage of your family-planning journey. You can also benefit from continuous opportunities to professionally develop with on-demand training, support, and global mobility opportunities across the business. We encourage all applicants to read our candidate privacy notice before applying to Avalere Health.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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

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.

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.

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing. What You'll Do Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines. Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate. Help to iteratively improve medical writing processes as appropriate. Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations. Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues. Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope. Qualifications Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing. Substantial clinical study protocol writing experience desired. Excellent communication, presentation, and project management skills. Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines. Working knowledge of statistical concepts and techniques. Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results. Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus. Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products. Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote). Familiarity with concepts of structured content management preferred. Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

SourcePro Search has a fantastic opportunity for a Senior Scientific Medical Writer with a leading pharmaceutical company in Montville, NJ. offers an excellent compensation/benefits package as well as relocation assistance. Description: Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. Provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities: Assuring quality and timely preparation of clinical documents across all therapeutic areas as assigned, including clinical study reports, clinical study protocols, investigator's brochures, clinical summaries and overviews. Assist in the development of clinical document content used to support successful global clinical development, approval and marketing of a drug. Implement the medical communication strategy for all regulatory submission documents as assigned. Use the Global Target Label (GTL) and all associated product strategy documents to effectively develop associated clinical documents in support of the Global Clinical Development Plan (CDP), validate individual study protocol design and clinical study report (CSR) key messages, and provide key messages for submission dossiers used to gain marketing approval for the assigned documents. Implement project level data presentation and messaging standards for the assigned documents. Independently author submission and study level documents (collaborating with the team) based on the strategy provided and is accountable for the format, content and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of. Mentor and coach associate scientific medical writers in the Global Medical Writing (GMW) department. REQUIREMENTS: Master's degree or equivalent with at least 4-5 years of experience in the pharmaceutical industry in total, including a minimum of 4 years in Medical Writing and demonstrated working knowledge of scientific principles. PhD degree or equivalent with at least 3-4 years of experience in the pharmaceutical industry in total, including a minimum of 3 years in Medical Writing and demonstrated working knowledge of scientific principles. Must have experience in developing clinical documents in support of regulatory submissions globally (i.e. multiple regions) in more than one therapeutic area. Must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA). Must have experience in electronic document management and electronic regulatory submissions, tools and standards. Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas. Must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Global Development organization. ****************************

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.