Medical writer jobs in Trenton, NJ

Job Title: Lead Medical Writer Department: Medical Writing 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 (e.g, 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 top-line information pertaining to content of business development meetings; educates internal, non-medical team members about content-related issues CORE COMPETENCIES FOR THIS POSITION (The behaviors, skills and practices required to accomplish the objectives of this position and in the daily conduct of business.) Written Communications-Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect Timely Decision Making-Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision Informing-Provides the information people need to know to do their jobs and to feel good about being a member of the project team; provides medical writers information and direction so that they can draft accurate, high-quality editorial content; is timely with information Delegation-Clearly and comfortably delegates both routine and important tasks and decisions; broadly shares both responsibility and accountability; tends to trust people to perform; lets team members finish their own work Composure-Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress CORE COMPETENCIES FOR ALL FISHAWACK POSITIONS Client Focus-Is dedicated to meeting and exceeding the expectations and requirements of clients; gets first-hand client information and uses it for improvements in services; acts with clients in mind; establishes and maintains effective relationships with clients and gains their trust and respect Functional/Technical Skills-Has the functional and technical knowledge, skills, and creativity to do the job at an extremely high level of accomplishment Ethics/Values/Integrity/Trust-Adheres to an appropriate and effective set of core values and beliefs during both good and bad times; acts in line with those values; acts in a direct and truthful way; can present the unvarnished truth in an appropriate and helpful manner; admits mistakes; doesn't misrepresent him/herself for personal gain INTERACTIONS (EXTERNAL & INTERNAL DEPARTMENTS) Clients Authors/Thought Leaders/Experts Vendors Contract or Freelance Employees All Employees 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 Special Knowledge/Skills Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel Proficiency in Internet and PubMed searches Ability to work independently with minimal supervision, and as part of a team

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.

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

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 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

Principal Medical Writer- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. **What You Will Be Doing:** - Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. - Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. - Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. - Mentoring and training junior medical writers, fostering a culture of excellence and professional growth. - Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs. **Your Profile:** - Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. - Significant experience in medical writing, particularly in regulatory submissions and clinical documentation. - Strong understanding of regulatory requirements and industry standards for clinical writing. - Exceptional writing and editing skills, with a keen eye for detail and clarity. - Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders. - A commitment to maintaining high standards of quality and compliance in all medical writing activities. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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.

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. Job Description Looking for Medical Writers in Springhouse, PA Client -Johnson and Johnson Please share the updated resume at sweta(at)irionline.com Additional Information

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. Travel: may be up to 10 days per year. Requirements You hold a relevant academic degree - preferably Master's level - and have experience within the pharma industry, and 8+ years within Medical Writing. Furthermore, you have: Experience in authoring clinical/regulatory documents. Excellent verbal and written communication skills with the ability to effectively communicate with a variety of teams and individuals, across time zones. Ability to understand, interpret and communicate data from clinical trials. Proven ability to work with and lead cross-functional, global teams of contributors. English at exceptional professional level, both written and spoken. An interest in developing and improving medical writing-related processes. As a person, you are a strong team player and proactive in nature, with a can-do attitude, and like to operate in an environment with opportunities to have high impact. You are comfortable working independently and can take decisions in complex situations. As we are taking new steps towards developing best-in-class therapeutics for patients with rare diseases we are looking for people who possess an entrepreneurial mindset who can handle ambiguity, analyze, and create clarity and desires to be part of an organization where everything isn't set in stone. The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere. Salary range: $160-185k/year DOE A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged. Benefits 401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Saving Account (HSA) Flexible Spending Accounts Various incentive compensation plans Accident, Critical Illness, and Hospital Indemnity Insurance Mental Health resources Paid leave benefits for new parents

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.

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.

Principal Medical Writer- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. What You Will Be Doing: * Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. * Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. * Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. * Mentoring and training junior medical writers, fostering a culture of excellence and professional growth. * Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs. Your Profile: * Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. * Significant experience in medical writing, particularly in regulatory submissions and clinical documentation. * Strong understanding of regulatory requirements and industry standards for clinical writing. * Exceptional writing and editing skills, with a keen eye for detail and clarity. * Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders. * A commitment to maintaining high standards of quality and compliance in all medical writing activities. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Overview / About us Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence. Responsibilities / Position overview We are seeking an advanced degree life-sciences professional to serve as a Senior Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges. The Senior Medical Writer will ensure high-quality content is developed for a wide range of medical communications projects and deliverables including clinical publications (manuscripts and abstracts), slide decks, scientific platforms, symposia, advisory boards, and training materials. In this role, the Senior Medical Writer has final sign-off authority and will review all deliverables on assigned accounts for technical accuracy, proper incorporation and interpretation of investigator/client data, and overall content and editorial quality. Experience supporting oncology publications accounts is highly desirable. Qualifications The ideal candidate will have an advanced degree in a life-sciences field, meticulous attention to detail and the ability to simultaneously work on multiple projects relating to multiple products in various therapeutic areas. Additional Requirements and Qualifications * PhD, PharmD, or MD * 2+ years' experience in a healthcare communications agency environment or similar * Outstanding writing, editing and communication skills and excellent command of the English language * Exceptional attention to detail in relation to both scientific content and editorial standards * Ability to adapt writing style to different materials and target audiences * High level of proficiency with Microsoft Office applications (particularly Word and PowerPoint) * Experience with referencing software and database searching desirable Benefits We offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance: * Competitive salary plus bonus scheme * Medical, dental, and vision insurance options * 401(k) plan with employer match * Generous amount of paid time off annually + 10 paid holidays * Employee Assistance Program * Company-paid short-term and long-term disability coverage * Flexible spending accounts for health and dependent care and much more * ---------------------------------------------------------------------------- #LI-Remote #LI-Remote Responsibilities We are seeking an advanced degree life-sciences professional to serve as a Senior Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges. The Senior Medical Writer will ensure high-quality content is developed for a wide range of medical communications projects and deliverables including clinical publications (manuscripts and abstracts), slide decks, scientific platforms, symposia, advisory boards, and training materials. In this role, the Senior Medical Writer has final sign-off authority and will review all deliverables on assigned accounts for technical accuracy, proper incorporation and interpretation of investigator/client data, and overall content and editorial quality. Experience supporting oncology publications accounts is highly desirable.

The Senior Science Writer in the Communications and Public Relations Department will assist the director of science communications in translating scientific data and information related to cancer research into content that helps educate the public, policymakers, media and the health care industry about cancer research advances, the AACR's mission, and the importance of biomedical science and funding. In this capacity, the senior science writer will assist the director in implementing the AACR's communications and public relations plans that facilitate the accurate communication and reporting of the latest advances in cancer research from the AACR's meetings, journals, partnerships, and other scientific activities. Responsibilities The Senior Science Writer writes and edits content that helps promote awareness of AACR's scientific activities among the public, policymakers, the media, and others interested in cancer research. Responsibilities include: Writing and editing scientific press releases, blog posts, and features about cancer research advances from the AACR's conferences, journal articles, and other scientific sources. Developing scientific content for the AACR websites and social media platforms. Staying abreast of the latest developments in various areas of cancer research, including basic and translational research, population research, and preclinical and clinical research. Researching and gathering information on scientific topics of interest and participating in the SciComm Journal Club. Assisting with the development of scientific video content for blogs and websites. Assisting with writing scripts and letters for leadership, newsletter, Annual Report, and other content. Collaborating with SciComm members and media relations staff to help identify important cancer research advances from AACR's journals, scientific conferences, programs, and other initiatives to communicate to the scientific/medical press, national press, policymakers, cancer research community, and the public. Occasionally traveling to AACR conferences and other scientific programs to cover important scientific advances on the blog and websites as required. Collaborating with other members of the AACR about science communications projects that support the AACR's mission and goals. Qualifications Ability to translate complex scientific concepts into lay language for press releases and other written materials, including science backgrounders, blog posts, development activities, and reports. Ability to write compelling science content for lay audiences. Skill to develop scientific video content, including interviews and editing. Possesses outstanding editing skills and knowledge of AP style guide. Excellent interpersonal skills, including being a team player capable of working effectively with AACR colleagues, membership, and leadership. Good understanding of biomedical terminology. Proficiency in social media. EDUCATION AND TRAINING: PhD in biomedical science; cancer research experience preferred. Minimum of seven years of experience writing science content for a variety of target audiences, including scientists, media, and lay readers. How to Apply: Please upload your resume and cover letter (required). Equal Opportunity Employer

Proposal Writer / Manager We are seeking an experienced Proposal Writer to lead and manage the development of high-quality responses to both federal government solicitations and commercial RFPs. The ideal candidate will combine strong writing skills with proven proposal management capabilities to help us win new business opportunities. Key Responsibilities: Overall Proposal Response Coordination · Manage the end-to-end proposal development process for US federal procurements and commercial RFPs · Develop proposal schedules and coordinate with contributors to meet strict submission deadlines, including draft reviews, leadership reviews, and final white-glove reviews · Coordinate production of final deliverables and ensure timely proposal submission Proposal Writing · Lead proposal strategy sessions and develop win themes tailored to each opportunity · Write, edit, and coordinate compelling proposal narratives that address the evaluation criteria client will use to review our proposals · Ensure compliance with solicitation requirements, as specified in the RFP/RFQ documents · Support oral presentation preparation and other proposal-related activities as needed · Develop and maintain proposal templates, content libraries, and lessons learned documentation Required Qualifications · Bachelor's degree · Excellent writing, editing, and communication skills · Prior experience as a Proposal Manager responding to US federal government procurements and/or commercial RFPs · Strong understanding of federal procurement processes and proposal evaluation criteria · Strong organizational skills and attention to detail, with ability to manage multiple proposals simultaneously under tight deadlines · Proficiency with Microsoft Office Suite, specifically Word and PowerPoint Preferred Qualifications · Experience working at a consulting firm · Experience with proposal automation tools

JobID: 210679822 JobSchedule: Full time JobShift: Day Base Pay/Salary: Chicago,IL $74,200.00-$99,000.00 Are you excited to be at the forefront of shaping the bank's strategic client relationships by working on complex proposals and delivering tailored solutions that drive business growth? You have found the right team! As a Proposal Associate in the Commercial Banking Sales organization within the Commercial and Investment Bank, you will play a critical role in managing and writing responses to Requests for Proposals (RFPs) for treasury services, commercial card, and healthcare payment services. You will collaborate with sales and product teams to create client-focused, concise, compelling, and compliant proposals that strategically position J.P. Morgan. The Proposal Team actively manages the process and writes proposals in response to RFPs for treasury services and commercial card products. This role begins working with the bank's proposal team members and other subject matter experts to write proposals in response to client/prospect RFPs. The Associate must independently manage projects from start to finish, ensuring that responses are complete, compliant and well positioned. After successfully writing proposals this role has the opportunity to transition into actively managing proposals which includes working in a team environment, managing, writing, editing and proofreading responses to multi-product RFPs. Job responsibilities * Incorporate and revise pre-approved written responses as well as newly crafted responses into proposals * Write custom, client-specific sections of the proposals Incorporate winning themes and features/benefits into the solution * Ensure proper and consistent messaging by proofing, editing, and rewriting all sections of the document as required * Identify any additional narrative needs and consult with subject matter experts to clarify details and develop custom responses * Incorporate graphical elements materials and help identify any additional graphic needs and work with graphic artists to develop and finalize * Translate and map technical information into language understood by all levels of clients * Understand the client's RFP request and provide consultative advice to deal team * Research topics, gather and analyze information and background materials * Submit newly crafted sections to content management team to create new, re-usable proposal content Required qualifications, capabilities, and skills * A minimum of 3 years of sales, implementation or support of treasury management, commercial card or healthcare payment services * A minimum of 2 years technical, business or proposal writing experience in banking/TS products. * Excellent business writing and grammar skills are essential * Intermediate to advanced Microsoft Word and Adobe Professional proficiency required * Proven ability as a self-starter, detail oriented, well organized and able to multi-task effectively * High level of independence, energy and integrity; demonstrates respect for a diversity of opinions and styles, and accepts accountability and responsibility * Exceptional communication and interpersonal skills * Ability to work effectively and efficiently as a team member on multiple projects with tight deadlines * Schedule flexibility to meet deadlines with the ability to work flexible hours as required during critical phases of the project * Ability to develop and maintain a broad knowledge of TS and Commercial Card products as well as the technology, equipment, operations processes and systems commonly used * College degree (BA or BS) required Preferred qualifications, capabilities, and skills * Understanding of government bidding/ corporate procurement requirements and process * Knowledge of TS, merchant, and/or commercial card products and services