Medical writer jobs in Bristol, RI - 153 jobs

BeOne Medicines USA, Inc. seeks Principal Medical Writer in Cambridge, MA: **Job Duties:** Responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. Also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed. Manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration). Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s). Contribute to the creation and maintenance of document writing template/guidance for the document types listed in the General Description part. Lead part of the maintenance of document writing template/guidance for the document types listed in the General Description part. Identify the questions/issues that require departmental discussion or team discussion with guidance from line manager/mentor. Identify the potential risks and make a mitigation plan with guidance from line manager/mentor. Resolves problems with guidance from line manager/mentor (eg, takes concrete actions according to the aligned decisions). Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes. Provide technical and operational mentorship to junior MWs (full-time employees and/or contractors/vendors). Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes. Provides topic sharing on regulatory writing and related knowledge within the department and across the company (and to cross-functional stakeholders with guidance from line manager/mentor). Full-time telecommuting is an option. **Minimum Requirements:** + PhD (or its foreign degree equivalent) in Biotechnology, Engineering (any field), Biochemistry, or a related quantitative discipline, and 2 years of experience in the job offered or in any occupation in related field, OR Master's degree (or its foreign degree equivalent) in Biotechnology, Engineering (any field), Biochemistry, or a related quantitative discipline, and 5 years of progressively responsible experience in the job offered or in any occupation in related field. **Special Skill Requirements:** + Writing clinical study reports; + Writing protocols; + Writing protocol amendments; + Analyzing, Synthesizing, and Presenting Complex Information utilized in Medical Documentation; + Working with regulatory authorities from multiple regions. Any suitable combination of education, training and/or experience is acceptable. Full-time telecommuting is an option. Disregard the below range, the selected candidate will earn a wage of $137,100 - $171,400 per annum. Submit resume with references to: Req.#: L24-150320 at: ATTN: Amy Nobriga, **************************. \#LI-DNI All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Praxis is seeing a Medical Writer who will work under the guidance of the Associate Director, Medical Writing and will help support the needs of one or more clinical development programs at Praxis. You will be responsible for completing accurate, high quality, and regulatory compliant documents in support of clinical trials and regulatory submissions. This requires the knowledge and expertise to collaboratively author required documents with support and input from the Associate Director, Medical Writing while also helping other teams follow medical writing processes and style requirements. This position will be remote and located in India. Primary Responsibilities Implements all activities related to the preparation of defined medical and regulatory documents, serving as writing lead on assigned documents or identifying when external writers are necessary for support Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports. Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications Supports clinical trial transparency and disclosures, including clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide Contributes to departmental development through editorial and review support for document templates, style standards, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables Ensures adherence to relevant SOPs and internal best practices Qualifications and Key Success Factors Bachelor's degree required within a scientific discipline. Advanced degree, CNS, and Rare Disease experience a plus. A minimum of 3 years of medical writing experience in Sponsor or CRO setting AMWA certification preferred Experience using medical writing systems and technologies including Veeva RIM Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance or demonstrated success within a regulated industry environment Represents the core Praxis values of Trust, Ownership, Curiosity, and Results Ability to think critically in a fast-paced environment with a keen sense of urgency and demonstrated ability in creating solutions Self-motivated, able to work autonomously, and able to be a key contributor to one or more high-functioning and collaborative teams Highly organized and detail-oriented with a passion to deliver quality results quickly Strong verbal and written communication skills with an ability to build relationships internally and externally Highest levels of professionalism, confidence, personal values, and ethical standards Qualifications Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

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. With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009. Job Description: In this role, incumbent will be expected to provide Medical Writing leadership for clinical development, registrational, and LCM programs. Serves as lead Medical Writer for key programs. Coordinates medical writing support for programs with internal and contract writers. Additionally, must posess the ability to guide and assists medical writers in the writing of documents that are components of clinical/ regulatory approval applications for new biologics or NME applications. Documents include: Sections of clinical trial applications, Annual Reports, and BLA/NDAs, Protocols and Protocol Amendments, Model Informed Consents, Model Privacy Consents, Investigator Brochures, Clinical Study Reports, and Expert Reports and other documents as appropriate. Additional skills: must be a strong technical leader, manage with excellent scientific, strategic and customer focused leadership. Partner with Clinical Operations and R&D team members to ensure completion of high quality, timely, clinical documentation. Expected Qualification: Masters or PhD in biology or related discipline. Equivalent combination of education and experience considered. 7+ years of related experience in biotech or pharmaceutical environment. Must have strong scientific and operational background. At least 3 years of experience managing staff. Additional InformationAll your information will be kept confidential according to EEO guidelines.

Senior Medical Writer Reports To: Vice President, Regulatory Affairs Join the Adventure! We are seeking a highly skilled, detailed-oriented, scientifically driven Medical Writing professional to join our growing biotech team as a Senior Medical Writer. This role is responsible for the development of high-quality clinical and regulatory documents and scientific publications. The ideal candidate will bring deep expertise in medical writing and a collaborative mindset to help drive our pipeline forward. Key Responsibilities Lead the planning, writing, and review of clinical and regulatory documents including: Clinical study protocols and amendments Investigator brochures (IBs) INDs, NDAs Safety narratives and annual reports Develop and write scientific content for peer-reviewed manuscripts, congress abstracts, posters, and slide decks. Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Preclinical/Research, and CMC to ensure alignment and accuracy of scientific content. Develop and maintain document templates and style guides in accordance with regulatory and company standards. Manage timelines and deliverables across multiple projects, ensuring high-quality output under tight deadlines. Provide strategic input on document content and regulatory strategy. Maintain up-to-date knowledge of therapeutic area(s), product(s), and relevant literature Mentor and/or manage junior medical writers or contractors. Qualifications Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field. Minimum of 4-6 years of medical writing experience in the biotech/pharmaceutical industry. Proven track record of authoring and managing regulatory documents for global submissions and scientific documents in peer-reviewed journals. Strong understanding of clinical research, data interpretation, and regulatory standards. Deep understanding of ICH guidelines, GCP, and regulatory requirements. Exceptional writing, editing, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Preferred Qualifications Experience in rare disease or neurology therapeutic areas. Prior involvement in NDA/BLA submissions. Familiarity with EMA and other ex-US regulatory requirements. Compensation and Benefits At CAMP4 Therapeutics, we offer a competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $120,000. - $228,000. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. In addition to base salary, employees are eligible to receive an annual bonus and equity incentive opportunities. Our benefits include medical, dental, and vision insurance; life and disability coverage; paid parental leave; a 401(k) plan with company contribution; Employee Stock Purchase Program, Trek Time (flexible time off); tuition assistance; and additional perks that support your well-being and professional growth. About CAMP4 CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (reg RNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4's proprietary RAPTM Platform enables the mapping of reg RNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at *************** and follow us @CAMP4tx.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Work with therapeutic teams to develop and/or edit scientific/clinical documents, including manuscripts, abstracts, posters, and slide presentations • Work effectively with company document management systems and related tools, templates, and procedures in order to ensure efficient internal and external review and approval of documents prior to final submission for publication or presentations at scientific congresses • Ensure a consistent style of writing and presentation of clinical data to maintain quality and ease of review by all contributing authors • Participate and contribute to Medical Affairs Publication Team meetings and to cross-functional working groups as needed to facilitate efficient development and submission of publications • Work with external and internal authors on company-sponsored publications to facilitate writing, review and submission to high-tier journals Skills: • Substantial experience (8-10 years) as a medical writer or equivalent working knowledge of clinical research, study design, and ability to present clinical data objectively in a clear, concise written format • Demonstrated competency in project management and the successful preparation and submission of peer-reviewed manuscripts • Outstanding written and verbal communication and interpersonal skills • Proficient in Word, Excel, PowerPoint, and Acrobat. Datavision expertise a plus • Highly organized, detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams • Ability to manage multiple projects simultaneously, thinks critically, and adheres to deadlines • Demonstrated customer facing skills and capability to collaborate with Key Opinion Leaders on publications and presentations in a credible manner • Ability to interpret and critique scientific and medical literature with respect to scientific and business implications is essential • Experience in Multiple Sclerosis therapeutic or neurology area preferred • Medical writing or publications experience with a pharmaceutical company or medical communications agency preferred Qualifications • Advanced degree (MS, PhD, PharmD) in biomedical sciences is preferred, but not required Additional Information For more information, Please contact Akriti Gupta ************** Morristown, NJ 07960

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Researches, writes, and edits clinical/statistical reports and study protocols: summarizes data from clinical studies for submission to the relevant governing regulatory body. Has experience in the analysis, summarization, and interpretation of scientific data and an ability to communicate clinical data succinctly, clearly, and accurately in writing. Years of Experience 3-5. Master's in a life science. Doctorate preferred Additional Information $45/hr 12 MONTHS

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Job Title: Medical Expert, Clinical Sciences Location: Boston, MA, Miami, FL or remote East Coast The Medical Expert, Clinical Sciences provides scientific and medical input to clinical development programs, contributing to the design, execution, and reporting of clinical studies. The role collaborates with cross-functional teams to ensure clinical activities are conducted in alignment with regulatory standards, Good Clinical Practice, and company objectives. The Medical Expert supports the development and writing of clinical documentation, provides medical insight and medical monitoring during study conduct, and contributes to data interpretation and communication of results. ESSENTION FUNCTIONS: Works as part of a diverse, cross-functional team responsible for the design, implementation, execution, and documentation of clinical studies supporting regulatory and business objectives. Provides scientific and clinical input (e.g., rationale, objectives, endpoints) to clinical development plans, Target Product Profiles, study outlines, protocols, investigator brochures, and other clinical documentation Contributes as a therapeutic-area scientific and medical expert in discussions with internal stakeholders (e.g., Clinical Development, Global Medical Affairs, Regulatory, and Product Strategy) Supports communication with external stakeholders (e.g., clinical investigators, CROs, and key opinion leaders) under guidance from senior colleagues or project leads. Provides medical support and safety medical monitoring during study conduct, addressing medically relevant questions and ensuring clinical data quality and integrity. Contributes to preparation of presentation materials for investigator meetings, protocol training sessions, and scientific advisory boards Participates in the review and interpretation of clinical data in collaboration with study and development teams. Supports preparation of study reports, clinical summaries, and regulatory submissions as needed. Collaborates with Global Clinical Safety in evaluating the drug or device benefit-risk profile, risk management activities and assists in documentation of safety-related findings. Performs other duties as assigned. EDUCATION, KNOWLEDGE & SKILLS: MD (or equivalent) required At least 2 - 3 years of industry experience required Experience in aesthetic dermatology or medical aesthetics preferred; injectable aesthetics experience advantageous Strong knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP Familiarity with global regulatory stands for medical devices and/or drugs Strong understanding of the clinical development process, data management, and risk management principles Fluent in English (written and oral) About the Compensation: The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the hiring range for this role is $170,000-265,000. In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance. We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more. What we offer in return You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training. Next Steps If your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager The final step is a panel conversation with the extended team Our people make a difference At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do. Employer's Rights: This does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this . The employer has the right to revise this at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

The mission of the Boston Public Health Commission (BPHC) is to work in partnership with communities to protect and promote the health and well-being of all Boston residents, especially those impacted by racism and systemic inequities. The BPHC envisions a thriving Boston where all residents live healthy, fulfilling lives free of racism, poverty, violence, and other systems of oppression. All residents will have equitable opportunities and resources, leading to optimal health and well-being. The BPHC sets an expectation that all staff and leadership commit, individually and as part of the BPHC team, to hold ourselves accountable to establishing a culture of antiracism and advance racial equity and justice through each of our bureaus, programs, and offices. We are seeking a Public Health Fellow to support an exceptional opportunity to work alongside leadership and to bridge the gap between complex scientific analysis and clear, impactful communication. This position is for a period of six months and is located within the Center for Public Health Science and Innovation. The Fellow will collaborate closely with leadership teams across the Commission to ensure crucial public health information is conveyed with clarity and precision. Reporting to the Director of Epidemiology and Evaluation this role ensures the accurate and accessible dissemination of research findings and technical information to diverse audiences, including stakeholders, academic peers, and the public. By employing expertise in research synthesis, manuscript development, and editorial precision, the position supports the creation of high-quality publications and reports that advance knowledge, inform policy, and contribute to evidence-based decision-making in public health. The ideal candidate will have a demonstrated interest in population health dynamics and social determinants of health. Competitive applicants will have superior writing skills, robust quantitative skills, and an aptitude for translational research in population health and social epidemiology. Essential Functions Draft and submit well-crafted, high-quality manuscripts that meet publication requirements in peer-reviewed journals. Lead and actively participate in the preparation of written reports and oral presentations summarizing data analysis results, including detailed description of statistical methods, detailed analysis of results, and synthesis of conclusions for internal and external meetings, scientific conferences, and academic journals. Conduct critical literature review of epidemiological and surveillance studies for study design and publication efforts. Collaborate with leadership to present study findings clearly and accurately. Ensure adherence to submission guidelines for journals. Support development of content for social media, newsletters, and web pages to communicate study outcomes to improve the visibility of research initiatives with measurable audience engagement across communication channels. Create and support creation of visually engaging materials to simplify complex information for non-technical audiences. Collaborate effectively in a team environment. Keeps abreast of the latest statistical techniques, their implementation and interpretations. Perform other duties as directed by leadership.

The Opportunity: The Senior / Manager, Medical Writing is responsible for independently authoring and delivering high-quality routine clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study-level activities. This position will work directly with the Director, Medical Writing. Your Role: Independently writing and delivering high-quality clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, integrated summaries, and sections of regulatory submissions) in partnership with internal cross-functional team members Coordinating effective document development, review, and approval Overseeing medical writing vendor writers for individual projects, as needed Actively contributing to development of processes and procedures to improve departmental and cross-functional workflows Building relationships and working collaboratively with study team members Reviewing study and program-level documents for clarity, accuracy, and consistency Developing in-depth study-level and program knowledge Contributing scientific knowledge and analytical skills to the production of documents Participating in developing key messages for clinical regulatory documents Developing document timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverables Leading development of clinical trial registry postings for assigned studies Navigating an electronic document management system and related tools to develop clinical documents Your Background: Bachelor's degree in relevant discipline required. PhD in molecular biology, genetics, or a related life sciences field preferred, (or equivalent degree). 3+ years of experience in the pharmaceutical/biotechnology industry as a medical writer Self-motived and nimble with the ability to excel in a fast-paced environment Excellent written and verbal communication skills Strong interpersonal skills Experience producing high-quality scientific/medical documents Ability to analyze, interpret, and summarize clinical data Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology Strong project management and organizational skills Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing department Attention to detail related to consistency, grammar, syntax, and scientific accuracy Proficiency in word processing, templates, table/figure creation, and literature searches Estimated Salary Range: [$107,000 - $179,000]. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location. #JO1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Overview Madrigal Pharmaceuticals is seeking an Senior Manager of Medical Writing. The successful candidate will play a crucial role in ensuring the accuracy, consistency and quality of clinical documents. This role is critical in supporting the company's mission to develop transformative therapies for patients with liver disease, primarily metabolic dysfunction-associated steatohepatitis (MASH). Responsibilities Write documents supporting Phase 1 though IV clinical trials (primarily clinical study protocols, clinical study reports and investigators brochures) Collaborate closely with cross-functional teams to create documents that support program goals and timelines Ensure that documents are of the highest quality and compliant with global regulatory requirements and industry best practices. This role may also include contributing to updates to standard operating procedures to reflect evolving requirements. Contribute to the development and implementation of processes and systems to optimize Madrigal's efficiency and productivity in document development Stay current with regulatory guidelines, industry trends, and best practices in medical writing Qualifications 6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development Able to: Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences Ensure accuracy and consistency in the quality control of documents with precise attention to detail Work collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexity Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP) Preferred : Familiarity with designing and operationalizing clinical studies Advanced degree in scientific area Experience in liver, cardiovascular or metabolic diseases Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $155,000 to $189,000 per year. All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact *********************. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to ********************* .

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit ********************** Position Summary Prime Medicine is seeking a Senior Manager, Medical Writing to support the development of high-quality clinical, regulatory, and scientific documents across our gene-editing pipeline. This role will be both hands-on and strategic, contributing directly to authorship while helping to build scalable medical writing processes in a rapidly growing organization. Reporting to the Head of Medical Writing, this individual will partner closely with Clinical Development, Regulatory Affairs, Research, and other cross-functional teams to ensure accurate, consistent, and timely documentation supporting global clinical trials and regulatory submissions. This is an excellent opportunity for an experienced medical writer who thrives in a collaborative, fast-paced biotech environment and wants to grow into increasing leadership responsibility. Key Responsibilities Medical Writing & Content Development Serve as primary author and/or lead writer for key clinical and regulatory documents, including: Clinical Study Protocols and Amendments Investigator's Brochures (IBs) Clinical Study Reports (CSRs) IND/CTA submission documents and briefing packages Critically analyze and interpret nonclinical, clinical, and external literature data to develop clear scientific narratives, conclusions, and messaging. Ensure consistency of content, data interpretation, and scientific positioning across documents and programs. Cross-Functional Collaboration Work closely with Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and Quality teams to: Drive document timelines Resolve data and messaging questions Ensure regulatory and scientific alignment Lead and participate in cross-functional document review meetings and support responses to health authority questions as needed. Process, Quality & Infrastructure Support the development and maintenance of: Medical writing templates, style guides, and standards Document workflows, timelines, and best practices SOPs and quality control processes Perform or oversee document QC, ensuring accuracy, clarity, formatting consistency, and compliance with internal standards and regulatory expectations. Evaluate and incorporate new writing support tools, including AI tools, to streamline processes and improve writing quality. Contribute to inspection readiness and submission quality initiatives. Leadership & Development (scope dependent on level) May mentor junior writers, contractors, or co-ops as the team grows. Provide guidance on best practices in medical writing, document planning, and scientific storytelling. Required Qualifications Advanced degree or bachelor's/master's degree in life sciences, health sciences, or a related field. ~5+ years of medical writing experience in biotech/pharma OR ~7+ years of writing experience in biotech/pharma or other scientific or academic setting. Includes document ownership and cross-functional leadership Strong experience authoring clinical and regulatory documents (protocols, IBs, CSRs, IND/CTA content). Solid understanding of clinical development and regulatory frameworks (FDA, EMA, ICH). Excellent written, verbal, and organizational skills with strong attention to detail. Proficiency with document authoring tools (e.g., Microsoft Word, Office suite, SharePoint, Adobe). Preferred Qualifications Experience supporting gene editing/therapy or biologics programs. Familiarity with rare disease clinical development. Experience contributing to submissions across multiple development stages. Comfort working in a hands-on, fast-moving biotech environment. The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits-including medical, dental, vision, life insurance, a 401(k) match, and equity programs-along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together. U.S. Pay Range $153,096 - $188,095 USD Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

Depending on candidate's education and experience, this hire could be at the Senior level. Science Writer & Editor/Senior Science Writer & Editor advances the Marine Biological Laboratory's (MBL) mission by producing high-impact science communications that engage diverse audiences, including the public, scientists, students, alumni, and donors. This role is the institution's lead writer and editor-crafting clear, compelling stories that illuminate MBL research, educational programs, and institutional priorities. Science Writer & Editor/Senior Science Writer & Editor serves as MBL's primary science news editor and leads media relations for research and education. The position develops strategic media outreach, builds strong relationships with journalists, and enhances MBL's visibility in both scientific and general media. The role also provides guidance and optional workshops for the Logan Science Journalism Program (LSJP), advising on storytelling and outreach strategies. This position reports to the Director of Communications. Key Responsibilities Science Writing & Editorial Leadership Research, interview, write, and edit science news stories, press releases, features, web content, and other materials that highlight MBL research and educational activities. Publish science stories to MBL website Serve as Science News Editor; oversee story development, editorial planning, and assignment of freelance writers. Ensure accuracy, clarity, and accessibility in all science storytelling, translating complex research for diverse audiences. Mentor and supervise writing interns or student communicators when needed. Coordinate with freelance science writers Supervise summer science writer intern Media Relations Lead MBL's science media strategy, developing proactive outreach plans that highlight key research findings, institutional initiatives, and educational programs. Pitch compelling science stories to local, national, and international outlets; collaborate with the University of Chicago News Office when appropriate to broaden reach. Respond promptly and professionally to media inquiries, providing accurate background, coordinating interviews, and shaping messaging to ensure clarity and consistency. Manage media visits to campus, including making arrangements for broadcast crews, documentary teams, photographers, and reporters; ensure scientists and staff are well-prepared and supported. Monitor, track, and analyze media coverage, identifying trends, opportunities, and areas for deeper engagement; prepare reports for leadership as needed. Cultivate trusted, long-term relationships with science journalists, editors, producers, and communications counterparts across the University of Chicago and partner institutions. Create opportunities for MBL scientists and students to engage with media through training sessions, workshops, and one-on-one coaching in best practices for interviews and public communication. Serve as an advisor to researchers on emerging media trends, science communication techniques, and strategies for translating complex concepts for general and scientific audiences. Uphold MBL's reputation by ensuring accuracy, diplomacy, and professionalism in all public-facing interactions, particularly around sensitive or emerging research topics. Identify and prepare spokespersons across the institution, helping match experts with media inquiries and ensuring they are briefed and confident. Digital Communications & Social Media Create and curate research-driven content for MBL's social media channels. Collaborate with colleagues to integrate digital storytelling with institutional priorities and research milestones. Contribute writing and editorial support to multimedia projects, including video scripts, web features, and digital campaigns. Advising for the Logan Science Journalism Program (LSJP) Collaborate with LSJP leadership to help shape the program agenda, ensuring alignment with MBL research strengths and institutional priorities. Serve as an on-site host and communications presence during the program, welcoming fellows and helping introduce them to the MBL community. Participate in or advise on the selection committee, offering insight into applicant backgrounds, science writing quality, and program fit. Support recruitment and advertising efforts, including crafting outreach language, identifying target audiences, and developing promotional materials. Offer editorial guidance or optional workshops for fellows on science writing or media practices. Assist with post-program communications and follow-up, strengthening the program's visibility and ongoing relationships with alumni and partners. Communications Office Support Serve as acting lead during the Director of Communications' absence. Contribute to institutional initiatives, including special events, video projects, public lectures, and strategic messaging campaigns. Work collaboratively across MBL departments, including Research, Education, and Development, to ensure unified and compelling communication. Perform additional duties as assigned. Qualifications Required Bachelor's degree and minimum of 5+ years of professional experience in science communication, science journalism, media relations, or related fields. Demonstrated excellence in science writing and editing for broad audiences. Strong media relations experience and proven success pitching science stories. Outstanding editorial judgment and attention to accuracy. Ability to manage multiple complex projects with tight deadlines. Strong interpersonal skills for working with scientists, staff, leadership, and external partners. Experience with web publishing and social media content development. Preferred Advanced degree in cell, molecular, or developmental biology, as well as training in journalism and science communication. Experience within a research, higher-education, or nonprofit environment. Photography or video production skills. Experience supervising interns or freelance writers. Awareness of best practices in communicating complex science to non-specialists. Additional Requirements Evening or weekend work for events or media visits as needed. Position requires extensive use of a computer and keyboard.

Veterans Inc., New England's largest provider of services for veterans and their families, is a mission-oriented, non-profit agency offering a fast-paced, professional work environment for an experienced, creative, and goal-oriented Grant Writer. The Grant Writer is a key member of the Development team and is responsible for researching, developing, and writing proposals, concept papers, grant solicitations, and other written materials to secure funding for program support and capital projects. The focus is on corporate and private foundations, as well as state and federal grants. This position will be guided by and report to the Senior Manager of Program Analysis & Reporting and other senior-level staff members when required. The position is onsite at our Headquarter Facility located on 69 Grove Street, Worcester, MA headquarters. WHAT YOU'LL BE RESPONSIBLE FOR DAY TO DAY: Identifying and developing sources to support existing and planned program activities. Acquiring and maintaining knowledge and understanding of the services of Veterans Inc. and using that information to comprehend all projects and programs for which grants will be sought and to recommend seeking grants based on our mission. Complies with all grants reporting as required. Research and maintain statistics and current data relevant to funding opportunities. As needed, serve as primary relationship manager/liaison with foundation and corporate funders. Prepare letters of inquiry, proposals, reports, budgets, acknowledgments, and other materials to secure and advance support. Responsible for preparing cost projections/budget development and submitting timely and accurate progress reports for grant-funded projects. WHAT YOU MUST HAVE: Bachelor's degree in a related field is required. Comparable amounts of skill and experience may be considered in lieu of a degree. Minimum of two (5) year's experience in grants research, writing, filing applications (manual and electronic), evaluation, project management, reporting, and public outreach/relations. Must have a solid understanding of grant compliance for Federal, State, and local entities. Exceptional project management skills (prioritizing, timeline, budget, procedure, reporting, and evaluation) required. Outstanding communication and organizational skills with strong grammar, creative writing, proofreading, and word processing skills required. Must be able to confidently and successfully manage competing deadlines and prioritize to accomplish tasks. Strong knowledge of the principles, ethics, and best practices of successful fundraising and donor stewardship, as well as the ability to work with confidential material and information, is essential. Must be able to pass a CORI background records check. Compliance with Veterans Inc. COVID-19 Vaccination Policy. Religious and Medical Exemptions are considered. The ability to work flexible hours is a plus! WHAT WE CAN OFFER YOU: Comprehensive Benefits Package for Full Time employees includes: BCBS Medical, Dental, and Vision Insurance Employer Paid Short and Long-Term Disability and Life Insurance. $2500 Medical Opt-Out program if you have medical coverage through another source. Retirement Plan (403B) with a $2000 Match Flexible Spending Accounts Tuition Reimbursement Program Paid Parental Leave For more information, or to apply now; visit our website. Please do not mail, email, or fax your cover letter/resume as we are limited to only accepting completed applications through our career page. Mailed, emailed, or faxed cover letter, resume, and applications will not be reviewed. Veterans Inc. is proud to be an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status. If you need assistance completing an application please contact ************************ . We do not accept unsolicited resumes from agencies. Agencies are requested not to contact Veterans Inc. with recruiting inquiries.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Work with therapeutic teams to develop and/or edit scientific/clinical documents, including manuscripts, abstracts, posters, and slide presentations • Work effectively with company document management systems and related tools, templates, and procedures in order to ensure efficient internal and external review and approval of documents prior to final submission for publication or presentations at scientific congresses • Ensure a consistent style of writing and presentation of clinical data to maintain quality and ease of review by all contributing authors • Participate and contribute to Medical Affairs Publication Team meetings and to cross-functional working groups as needed to facilitate efficient development and submission of publications • Work with external and internal authors on company-sponsored publications to facilitate writing, review and submission to high-tier journals. Skills: • Substantial experience (8-10 years) as a medical writer or equivalent working knowledge of clinical research, study design, and ability to present clinical data objectively in a clear, concise written format • Demonstrated competency in project management and the successful preparation and submission of peer-reviewed manuscripts • Outstanding written and verbal communication and interpersonal skills • Proficient in Word, Excel, PowerPoint, and Acrobat. Datavision expertise a plus • Highly organized, detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams • Ability to manage multiple projects simultaneously, thinks critically, and adheres to deadlines • Demonstrated customer facing skills and capability to collaborate with Key Opinion Leaders on publications and presentations in a credible manner • Ability to interpret and critique scientific and medical literature with respect to scientific and business implications is essential • Experience in Multiple Sclerosis therapeutic or neurology area preferred • Medical writing or publications experience with a pharmaceutical company or medical communications agency preferred Qualifications • Advanced degree (MS, PhD, PharmD) in biomedical sciences is preferred, but not required Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

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. Location: Groton, CT Duration: 3 years+ Our client is looking to hire the Medical Writer Job Description: • Company is looking for medical writers with experience submission on the CTD Modules for NDAs and MAAs, clinical overview, biopharmaceutics and associated analytical methods, summary of clinical pharmacology studies, summary of clinical efficacy, and/or summary of clinical safety. • Experience with oncology is also desirable. • The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. • This will be achieved by applying analytical skills, functional literacy and expertise in document preparation. • The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy summaries, responses to regulatory questions, safety updates and regulatory briefing documents. • May also, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors. PRIMARY RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • Skills of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical and other key stakeholders. May also: • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents. • Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management. • Serve as the point of contact (“go to” person) for one or more projects or products. • Organize and lead a MD matrix team of authors to deliver all MDL deliverables for each assigned project. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents. • Exhibits sound project management and time management skills. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise. May also include: • Able to project manage and appropriately prioritize medium to high volume of work, with short Feel free to forward my email to your friends/colleagues who might be available. Additional Information Thanks!!! Warm Regards, Amrit Singh Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Tel: (732) 429 1634 Fax: (732) 549 5549 http://www.irionline.com Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Researches, writes, and edits clinical/statistical reports and study protocols: summarizes data from clinical studies for submission to the relevant governing regulatory body. Has experience in the analysis, summarization, and interpretation of scientific data and an ability to communicate clinical data succinctly, clearly, and accurately in writing. Years of Experience 3-5. Master's in a life science. Doctorate preferred Additional Information $45/hr 12 MONTHS

The Grant Specialist (GS) reports to the Director of Post Award Grant Accounting and assists with overseeing the financial management and compliance of all sponsored grants and contracts awarded to the Boston Public Health Commission (BPHC). This position will provide financial and grant management oversight and leadership to the programmatic staff, while ensuring that BPHC meets the terms and conditions of the sponsors/funders by tracking and meeting report deadlines, managing audit compliance, and implementing institutional policies and procedures. Responsibilities for this position include, but are not limited to, the following: Grant Compliance and Reporting: Maintain financial management and oversee compliance for an assigned portfolio of grants and contracts; in accordance with government regulations, funder requirements, and BPHC Policies. Review new/revised grants/contracts set-up requirements within accounting system for accuracy and compliance. Work collaboratively with programs & departments to ensure compliance requirements of grants/contracts are met. Assist with managing annual Uniform Guidance Audit and other sponsor audits as necessary. Review grant-related financial transactions prior to entry into accounting system. Ensure project expenditures are expensed in accordance with the terms and conditions of the award and/or BPHC policy. Review general ledger for unallowable costs posted to awards. Prepare detailed, accurate, timely, and quality financial analyses of grant transactions. Ensure that project records are kept in good order and readily available for review and audit. Ensure that the project complies with all appropriate Commission payroll, reimbursement, accounting, and personnel policies and practices. Ensure cost-share budget and expense reports comply with BPHC's cost-sharing policy and are available for audit. Advise and assist Program Directors (PDs) and Bureau Administrators (BAs) in fulfilling the departmental award closeout requirements in accordance with the sponsor's and BPHC's closeout policies. Provide backup coverage to the other grants specialists for vacation coverage or during high volume. Other job-related duties as assigned. Grant Accounting/Budgeting: Assist PDs and BA's in the financial management of new and continuing grants/contracts, including budget amendments, budget-to-actual analysis, no-cost extensions, close-outs, reporting, and interpretation ofsponsor/funder regulations. Routine review of project expenditures, including fringe benefit and facilities and administration costs. Process invoices to grantor agencies/funders in a timely manner and monitor collection of grant receivables. Reconcile grant A/R billings with cash receipts and financial reports. Work to resolve discrepancies with the Accounting team. Prepare grant-related journal entries, including salary and wage, indirect expense allocations and reclassifications. Ensure that cost transfers resulting from unusual circumstances or unanticipated project expenses are appropriately documented and transferred to the correct source of funds prior to close-out of the award. Meet regularly with PDs and BAs to keep them apprised of the grant/contract's progress, review project financial transactions/reconciliations, and provide direction where needed. Monitor encumbrance balances on a monthly basis and ensure that the balance reflects current purchase obligations for the award and that obsolete purchase orders are voided or closed on a timely basis. Assist in the preparation of grant/contract financial reports or invoices that require confirmation of completion of deliverables prior to submission or any required supplemental information.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Work with therapeutic teams to develop and/or edit scientific/clinical documents, including manuscripts, abstracts, posters, and slide presentations • Work effectively with company document management systems and related tools, templates, and procedures in order to ensure efficient internal and external review and approval of documents prior to final submission for publication or presentations at scientific congresses • Ensure a consistent style of writing and presentation of clinical data to maintain quality and ease of review by all contributing authors • Participate and contribute to Medical Affairs Publication Team meetings and to cross-functional working groups as needed to facilitate efficient development and submission of publications • Work with external and internal authors on company-sponsored publications to facilitate writing, review and submission to high-tier journals. Qualifications Substantial experience (8-10 years) as a medical writer or equivalent working knowledge of clinical research, study design, and ability to present clinical data objectively in a clear, concise written format • Demonstrated competency in project management and the successful preparation and submission of peer-reviewed manuscripts • Outstanding written and verbal communication and interpersonal skills • Proficient in Word, Excel, PowerPoint, and Acrobat. Datavision expertise a plus • Highly organized, detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams • Ability to manage multiple projects simultaneously, thinks critically, and adheres to deadlines • Demonstrated customer facing skills and capability to collaborate with Key Opinion Leaders on publications and presentations in a credible manner • Ability to interpret and critique scientific and medical literature with respect to scientific and business implications is essential • Experience in Multiple Sclerosis therapeutic or neurology area preferred • Medical writing or publications experience with a pharmaceutical company or medical communications agency preferred Education: • Advanced degree (MS, PhD, PharmD) in biomedical sciences is preferred, but not required Additional Information For more information, please contact Sneha **************

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 RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents. • Manage contract writers, as well as internal writers. • Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses TECHNICAL KNOWLEDGE: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Able to complete and turn around high quality outputs with only minimal guidance from management. Qualifications QUALIFICATIONS AND SKILLS NEEDED: • Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. • Experience with oncology and eCTD filing preferred. Additional Information Tel: 732-429-1921 http://www.irionline.com