Medical writer jobs in Robbinsville, NJ - 52 jobs

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

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.

Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx *You can apply through Indeed using mobile devices with this link. Additional Information

Bioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network-and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations Job Description The Medical Writer will be responsible for the creation and development of all study start-up documents such as the Site Manual and associated forms, as well any required Protocol Amendment Impact forms and Compliance Reports for the life of each study. The Medical Writer is also expected to provide guidance and support to the Clinical Project Management Team, including the review of Project-Specific Work Instructions and attending document-related Sponsor calls. Primary Responsibilities Performs study start up responsibilities by: Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries Creating, modifying and finalizing Quality Control (QC) Summaries Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation Reports Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs Creating, modifying and finalizing paper Source Documents based on ToOs Creating, reviewing, modifying and finalizing MedComm Meeting Minutes Attending internal and external meetings relating to the Site Manuals, IQA/PQA/QC Summaries, CRs/KPDs, Source Documents and any other MedComm-related study start-up documents Running Scheduled Tasks for generating MedComm webpages Maintaining MedComm document webpages Checking MedComm webpages for errors Performing Project Close-outs as they occur based on receipt of Study Closure forms Reviewing and updating Charter Training Slides (CTS) and CTS quiz(zes) as needed Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required Manages the clinical study document development process by: Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled Providing guidance to assigned Project Teams and Project Team members Providing language updates, as required, for all MedComm document templates as needed Creating Final Effective documents Secondary Responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Updating department SOPs and Work Instructions as needed Assisting in establishing and enforcing departmental standards Contributes to team effort by: Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Participate in internal training activities Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by: Staying up-to-date on response criteria publications posted by Medical Communications Participating in Medical Writing Training activities, including creating/reviewing training modules Participating in Clinical Project Management Training activities, including creating/reviewing training modules Attending and participating in applicable company-sponsored training Qualifications Education: Bachelor's Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred Experience: 1+ years medical writing experience required 2+ years of experience in pharmaceutical/clinical/imaging research preferred Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access) Understanding and knowledge of medical and/or clinical trial terminology desired Additional skill set: Ability to work in a group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Organization and time management skills for managing multiple projects concurrently Additional Information Working conditions: Travel: 0-5% Lifting: 0-10lbs Other: Computer work for long periods of time EEO Statement Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

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

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.

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

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Remote Employee Value Proposition: At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to experience multiple facets of medical writing in a dynamic, collaborative, and cross functional environment. Position Summary: The Senior Medical Writer, Medical Writing is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval. Performance Objectives: Responsible for the development of high-quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including but not limited to Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments,. Collaborate with Global Development Teams and Clinical Development to ensure alignment with program objectives. Participates in Global Medical Writing initiatives on clinical development cross-functional teams. Assists with development and implementation of Medical Writing processes improvement in line with SOPs. Owns and updates assigned Medical Writing SOPs, as necessary. Education/Certification Requirements: Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Knowledge, Skills, and Abilities: Minimum of 3 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents. Previous experience in Medical Writing in clinical drug development, preferably some experience in oncology. Working knowledge of Medical Writing requirements and document components. Experience with templates and template development, and document management systems. Excellent writing skills. Good interpersonal skills that involve working well in a team environment and the ability to lead others. Good organizational and planning skills; drive for results. Ability to read, analyze and interpret scientific and technical information. Effective analytical/problem solving skills. Ability to write procedures. Ability to follow instructions and synthesize information from multiple sources. Strong PC skills including intermediate/advanced proficiency with MS Word, and basic proficiency with other MS Office products. Adept in learning additional software utilized at Taiho. The pay range for this position at commencement of employment is expected to be between $116,450 - $137,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Remote

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.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Position: Sr. Technical Writer Duration: 6+ contract Location: Bridgewater, NJ Direct Client: Immediate interview SR tech writer. The person has to be very familiar with working in an R&D shop writing very detailed Functional Specifications working with developers and understanding the software development life cycle. The candidate should be able to write very precise business and technical requirements in order to write Requirement Specification documents. I want a senior level persons who can self Manage and motivate and some biology, life science, pharma, biotech or cro experience. Sr Technical Writer/Lead to assist with writing requirements, FS, management of documents, coordination, knowledge of document management tools like Alfresco, SVN 9 version control, Robohelp, Adobe, Word, etc. Need excellent writing skills, technical background and experience of clinical trials domain/ CRO/Medical Device is must. . Experience in Pharma, CRO, Medical Device or Biotech industry is a must. Long Term Contract opportunity. Additional Information Regards, Nagesh 732-429-1641

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

Buzz Clan is a business consulting company collaborating to provide Oracle and other software advisory services & implementation Services specialists by our Public & Private sector clients. We have been catering to wide-ranging technologies and platforms and have consistently been delivering the best available talent to Fortune 500 clients across different industry verticals and public sector clients of North America. I would like to discuss the opportunity with you. Please go through the job description and let me know if you are interested in applying for this position. Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM&M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We're looking to add an Associate Medical Editor to our Editorial Services team. The Associate Medical Editor role is entry-level and is ideal for individuals with minimal experience in editorial tasks or the healthcare/pharmaceutical industry who are eager to develop their expertise in medical editing. This role will work under supervision to gain proficiency in proofreading, copyediting, and applying the AMA Manual of Style (11th Edition) while becoming familiar with our agency's tools, systems, and workflows. What You'll Do Proofread and copyedit a variety of scientific and medical materials, including manuscripts, slide decks, abstracts, and educational content for healthcare professionals and patients Ensure grammatical accuracy, consistency, and adherence to style guides (including AMA Manual of Style) Verify that content aligns with scientific data, regulatory requirements, and client objectives Collaborate with medical writers, designers, project managers, and account managers to enhance the clarity and quality of deliverables Assist in maintaining consistency and compliance with ethical and industry standards Manage multiple projects under tight deadlines while ensuring high editorial standards What You'll Have Internship to 1 year of experience in an editorial capacity Bachelor's degree in English, Journalism, Communications, Life Sciences, or a related field Proficiency in Microsoft Office Suite; familiarity with editing tools and content management systems is a plus Strong attention to detail and ability to spot grammatical, stylistic, and factual inconsistencies Basic familiarity with medical terminology and scientific content is preferred Ability to learn quickly and work under supervision to develop expertise in medical editing Excellent time management and organizational skills to handle multiple projects What We Offer Immediate eligibility for all benefits, including medical, dental, vision, group term life, short-term and long-term disability Benefits 100% company paid 401k plan employer matching contributions Eligibility for company sponsored incentive plans Generous PTO, including a week off in December for the holidays Paid volunteer time off Tuition reimbursement On-site gym and other employee wellness initiatives Employee Assistance Program Comp pay or comp time for onsite weekend work Availability of cell-phone stipends, based on business need Leadership development training program and other career development programs Remote and hybrid work schedule options Salary range: $50,000 - $60,000 annually. Note: Actual salary will depend on background and experience. M/F/D/V Please note, we will only respond to candidates we deem qualified

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 Masters or Doctoral degree in a medical/scientific discipline. You are proficient in PowerPoint and Word, with excellent writing and editorial skills - an English degree or minor is a plus. You have the ability to convert scientific data into a clear, scientifically sound, well-structured 'story'. 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

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.

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