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  • Principal Medical Writer

    Beone Medicines

    Medical writer job in Cambridge, MA

    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.
    $137.1k-171.4k yearly Easy Apply 13d ago
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  • Principal Medical Writer

    Candel Therapeutics

    Medical writer job in Needham, MA

    Salary: $175-$190k Core hours: Eastern Time Zone Why Work With Us: At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. We are a high-performing team that shows up for each other and stays focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability-encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it's an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: **************** Position Summary We are seeking an experienced Senior Medical Writer to lead, plan, author, and manage high-quality clinical and regulatory documents for Candel's oncology programs. The role focuses on authorship of BLA components, Clinical Study Reports (CSRs), and Investigator's Brochures (IBs). This position requires hands-on regulatory writing expertise aligned with ICH, FDA, and EMA expectations, strong cross-functional collaboration, and disciplined project management to meet key submission timelines. This role is remote within the U.S., with preference for candidates in Eastern or Central time zones. What You'll Do Regulatory authorship and content development: Serve as an author for BLA clinical modules, including Module 2.5 Clinical Overview, Module 2.7 Clinical Summary, and relevant Module 5 clinical study content Author and update Clinical Study Reports, Investigator's Brochures, and SOPs. Contribute to protocols, protocol amendments, SAP-aligned data displays and appendices, clinical sections of briefing packages, and responses to health-authority queries Document strategy and project management: Develop document strategies, outlines, and timelinea Manage version control and drive document review cycles to audit-ready completion Cross-functional collaboration: Coordinate input from Clinical, Biostatistics, Regulatory, Safety, and CMC functions to ensure accuracy, consistency, and timely delivery Data interpretation and narrative development: Translate complex clinical and statistical results into clear, consistent regulatory narratives aligned with labeling and submission objectives Standards, compliance, and process improvement: Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions Contribute to template and process improvements Submission and inspection readiness: Support inspection and submission readiness, including document quality checks, traceability to source data, and comment reconciliation Milestone, risk, and issue management: Track milestones and risks, escalate issues proactively, and drive resolution to maintain delivery commitments What You'll Bring Required (must have all) 7+ years' medical writing in pharma/biotech/CRO with substantial oncology experience Bachelor's degree in life science (advanced degree preferred) Authorship of BLA clinical modules (2.5, 2.7, relevant 5), CSRs, and IBs Contributions to protocols/amendments, SAP-aligned tables/appendices, briefing packages, and health-authority responses Strong knowledge of ICH/FDA/EMA; oncology trial design, endpoints, and evolving regulatory expectations Ability to interpret clinical and statistical results and craft clear, compliant regulatory narratives Exceptional writing, editing, and project management; effective independent and cross-functional execution in fast, deadline-driven settings Ownership of document strategy, outlines and timelines, version control, and end-to-end review to audit-ready quality Direct experience with submission and inspection readiness, including quality control, data traceability, and comment reconciliation Participation in major submissions (BLA/NDA/MAA) through filing and review including assisting with responses to Agency queries. Proficiency with document and workflow systems (e.g., Veeva, eTMF, CTMS, electronic review tools) Proven collaboration with Clinical, Biostatistics, Regulatory, Safety, and CMC; consistent milestone and risk tracking with timely issue resolution Ability to work core Eastern or Central U.S. hours (remote, U.S.-based) Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.
    $175k-190k yearly Auto-Apply 15d ago
  • Medical Writer

    Integrated Resources 4.5company rating

    Medical writer job in Cambridge, MA

    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.
    $82k-116k yearly est. 60d+ ago
  • Senior Medical Writer

    Camp4 Therapeutics 3.9company rating

    Medical writer job in Cambridge, MA

    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.
    $120k-228k yearly 60d+ ago
  • Medical Writer - India (56829)

    Praxis Precision Medicines

    Medical writer job in Boston, MA

    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.
    $79k-118k yearly est. 19d ago
  • Medical Writer III : 4710313

    Artech Information System 4.8company rating

    Medical writer job in Cambridge, MA

    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
    $79k-111k yearly est. 1d ago
  • Medical Expert, Clinical Sciences

    Galderma 4.7company rating

    Medical writer job in Boston, MA

    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.
    $170k-265k yearly Auto-Apply 57d ago
  • Public Health Fellow - Scientific Writer

    Internships.com 4.1company rating

    Medical writer job in Boston, MA

    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.
    $85k-126k yearly est. 7h ago
  • Senior Manager, Medical Writing

    Maplight Therapeutics

    Medical writer job in Burlington, MA

    Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You'll Do: Reporting to the Head of Medical Writing, the Senior Manager, Medical Writing will be responsible for directly authoring and managing the development of high-quality medical and scientific documents to support the development, regulatory approval, and commercialization for one or more of our products. This role requires close collaboration with cross-functional teams to ensure timely, compliant, and high-standard deliverables that meet global regulatory requirements. The ideal candidate will have extensive experience in medical writing and scientific communications, with a strong understanding of both early- and late-stage drug development processes. Responsibilities: Author and manage regulatory documents for global submissions in accordance with ICH and other international guidelines, internal standards, and project timelines. Lead and coordinate medical writing activities for assigned programs, including internal teams and external vendors, ensuring timely and accurate submissions to regulatory authorities. Provide strategic input on medical writing deliverables, timelines, and processes during cross-functional meetings. Drive process improvements and serve as a subject matter expert on document types, workflows, and technologies. Partner with the Head of Medical Writing to evaluate and implement innovative approaches to document development, review, and quality control. Partner with the Head of Medical Writing to develop and maintain SOPs, templates, and best practices to ensure consistency and efficiency in document preparation. Oversee contract writers as needed, including defining scopes of work and monitoring deliverables and budgets. Apply therapeutic area and product knowledge to ensure scientific accuracy and clarity in all documents. Collaborate with internal stakeholders to establish style standards and quality control measures for high-quality outputs. Qualifications: Advanced degree (PhD, PharmD) in a scientific discipline preferred; Master's degree with at least 5 years of medical writing experience in pharma/biotech required. In-depth knowledge of regulatory requirements and guidelines (ICH, GCP, FDA, EMA) and familiarity with AMA style. Exceptional writing, editing, and verbal communication skills. Strong project management skills with the ability to prioritize and manage multiple projects. Proficiency with medical writing tools and software. Meticulous attention to detail and commitment to quality. Solid understanding of the drug development process and strong business acumen. Experience managing vendors and contractors is a plus. Strategic thinker with analytical skills and ability to thrive in a fast-paced environment. Collaborative team player with strong interpersonal skills and ability to build effective relationships across functions and with external partners. Location: This is a hybrid role with three days per week in-office in Burlington, Massachusetts. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave. Salary Range$168,000-$205,000 USD EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
    $168k-205k yearly Auto-Apply 23d ago
  • Senior Manager, Medical Writing

    Madrigal 4.3company rating

    Medical writer job in Boston, MA

    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 ********************* .
    $155k-189k yearly Auto-Apply 60d+ ago
  • Senior / Manager, Medical Writing

    Relay Therapeutics 4.6company rating

    Medical writer job in Cambridge, MA

    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!
    $107k-179k yearly Auto-Apply 5d ago
  • Senior Manager, Medical Writing

    Prime Medicine

    Medical writer job in Watertown Town, MA

    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.
    $153.1k-188.1k yearly Auto-Apply 21d ago
  • School-Based Grant Writer (PT, potentially FT)

    Codman Academy Charter Public School

    Medical writer job in Boston, MA

    School-Based Grant Writer Reports To: Chief of Staff Position Type: Part Time/In Person, potentially considering this as a FT. Salary: $30,000 - 40,000 (Part Time). We are potentially considering this as a FT role at $60,000-80,000. Position Overview The School-Based Grant Writer plays a critical role in advancing Codman Academy's mission by identifying, securing, and managing external funding opportunities that support academic innovation, enrichment, student wellness, and community partnerships. The Grant Writer works collaboratively with school leaders, teachers, Executive Director of External Affairs and community partners to develop compelling proposals that align with Codman's strategic priorities and ensure compliance with funding requirements. This position requires strong writing skills, attention to detail, and the ability to manage multiple projects simultaneously in a fast-paced school environment. Key Responsibilities Grant Research and Strategy * Research and identify grant opportunities from federal, state, and local agencies, private foundations, and corporate donors that align with school priorities. * Maintain a comprehensive calendar of grant deadlines, submissions, and reporting requirements. * Collaborate with leadership to prioritize funding needs and develop a multi-year grant strategy aligned with Codman's mission and goals. Proposal Development * Lead the preparation and submission of high-quality grant proposals, letters of inquiry, and applications. * Work closely with school and program leaders to gather data, budgets, narratives, and supporting materials. * Develop compelling narratives that articulate Codman's impact, innovation, and community engagement. * Ensure proposals are accurate, complete, and submitted on time. Grant Management and Reporting * Monitor progress of funded projects to ensure compliance with grant terms and deliverables. * Collaborate with the finance team to track budgets, expenditures, and reporting requirements. * Prepare interim and final reports for funders, demonstrating outcomes and impact. * Maintain organized documentation and records for all grant-related activities. Relationship Building and Communication * Cultivate relationships with funders, foundation officers, and community partners. * Represent Codman Academy in meetings and communications with grant agencies as needed. * Collaborate with the communications team to share success stories and outcomes funded by grants. Capacity Building and Internal Support * Provide guidance to staff on proposal writing, budgeting, and compliance. * Develop internal tools, templates, and training materials to strengthen grant-readiness across departments. * Support strategic initiatives that expand Codman's community partnerships and external funding base. Qualifications Required: * Bachelor's degree in English, Communications, Education, Public Administration, or related field. * Minimum of 3-5 years of grant writing experience, preferably in education, nonprofit, or public sector settings. * Proven success in securing funding from foundations, corporations, or government sources. * Exceptional written and verbal communication skills. * Strong organizational and project management abilities, with attention to detail and deadlines. * Ability to work collaboratively with educators, administrators, and partners. Preferred: * Experience with K-12 education or charter school environments. * Knowledge of DESE, federal, or state education grant processes. * Familiarity with databases such as Foundation Directory Online, Instrumentl, or Grants.gov. About Codman Academy Codman Academy Charter Public School, located in Dorchester, MA, is a mission-driven, full-service school committed to educating the whole student. Through rigorous academics, enrichment, and community partnerships, Codman prepares students for success in college, career, and civic life.
    $60k-80k yearly 43d ago
  • Grant Writer

    Veterans 4.4company rating

    Medical writer job in Worcester, MA

    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.
    $53k-78k yearly est. 60d+ ago
  • Copywriting Intern

    Connelly Partners 3.5company rating

    Medical writer job in Boston, MA

    Creative Department: Copywriting Intern Humble? Hungry? Care about ideas that actually move people? We're looking for a Copy Intern who's excited to learn, collaborate, and make work that matters. Please send a resume and a link to your online portfolio with spec work that shows conceptual thinking. CONNELLY CONTENT STUDIO: We make stuff. Social stuff. Timely stuff. Stuff people WANT in their feeds. Not ads preaching. But authentic content. Sometimes useful. Sometimes funny. Always relevant. We entertain, delight and educate on behalf of the brands we serve. We're scrappy. We write, design, shoot, edit, and animate stuff ourselves. We're ideas first, make it second. We try stuff with no fear of failure. Because the more we try, the more we learn. Together. We are the CP Content Studio. A nimble and hungry intern group specializing in design, photography, writing, video, and visual arts. Our goal is to make social content for brands that will resonate with their social audience. Each week, we'll pick a CP client to audit their and competitor's social channels. From Titleist, to Gordons, to Uno's and beyond. Initially, we'll generate droves of written ideas and discuss as a group with the Creative Director. Then, we'll pick some of them to bring to life. We'll shoot, edit and comp stuff up. With the singular goal of generating audience engagement to help our clients' businesses. And have a blast in the process. INTERNSHIP OVERVIEW: As a Content studio intern, you'll join the creative team to create content and play a role in the entire production process. With guidance and mentorship from the Creative Director, you'll collaborate with other members of the content studio to create compelling concepts, meaningful connections and relevant and innovative work while gaining hands on experience working on several established brand clients. ESSENTIAL JOB DUTIES: Ensure the creative vision and brand voice is implemented Assist in the development of ideas that stem from empathetic insights, cultural observations and timely social topics of discussions Write videos, social post content ideas, headlines and post copy Think conversationally and systematically understanding social content as a back and forth between a brand and consumers Work with art directors, photographers, videographers, other members of the team to frame your ideas Present your own ideas with confidence WHO WE'RE LOOKING FOR: Currently enrolled in a copywriting/advertising program Conceptual thinker who is able to think both in terms of words and visuals and how they work together to solve real marketing problems Excited to bring many ideas forward and see them through Team player **Portfolio required for this position**
    $39k-52k yearly est. 60d+ ago
  • Grant Writer and Administrator - Quincy College

    Quincy College 3.7company rating

    Medical writer job in Quincy, MA

    This is an on-site position. Under the direction of the President's Office and in collaboration with the VP of Student Success and Partnerships as well as all college departments, the Grant Writer and Administrator researches and identifies grant funding opportunities and develops/submits grant funding applications/proposals. The Grant Writer collaborates with Quincy College's faculty and administrators to identify institutional grant needs/opportunities across Quincy College departments. The Grant Writer and Administrator is responsible for all functions related to grant writing and administration. The Grant Writer stays abreast of evolving laws, regulations, and grant requirements. The grant writer is responsible for the administration/reporting of grants. Additionally, this position is a lead role in alumni affairs and development initiatives involving stewardship and donors. ESSENTIAL FUNCTIONS: * Conduct and coordinate the full range of activities required in a timely fashion with preparation, management and submission of grant proposals. * Conduct and coordinate the full range of activities required with regard to the administration of grants. * Developing and writing grant proposals to foundations and other grant-making organizations. * Assembling and submitting grant requests, including letters, proposals, budgets, and presentations. * Work with Finance and other departments, to gather information as well as report to funders on current grant programs. * Comply with all required grant reporting. * Provide stewardship to current donors, including work with Institutional Research to provide regular written updates to donors. * Maintain and track donor databases/records. * Ensure that proposals are in correct format, complete, and meet funding agency deadlines for submission. * Understand institutional history and programs. * Arrange for onsite tours for supporters (foundation officers, foundation trustees). * Perform lead role in all alumni affairs and development initiatives. * Ensure that all federal, state and private grants comply in accordance with legal rules and regulations. * Maintain and verify payment records, reviews invoices and record receipts. * Prepare monthly reports on the funded project status and submit them to the funders. * Analyze and evaluate grant budgets for correct calculation of expenditure categories such as salaries, indirect costs, materials, and equipment. * Maintain current records in database and in paper files, including grant tracking and reporting. * Track statistics relevant to development and provide department with written materials necessary for donor stewardship (visitor number and diversity, educational program attendance, etc). * Provide development input for all written institutional materials. * Assist with other fundraising projects as requested. * Serve on college committees as needed/directed. * Attend and participate in meetings of the Division of Academic Affairs; * Participate in mandatory training/coursework. Including but not limited to: Title IX and Sexual Misconduct Sexual Harassment and Non-Discrimination Security Policy and Notification of Security Reporting FERPA Municipal Ethics Law * Assume other duties as assigned. Requirements: EDUCATIONAL EXPERIENCE: Bachelor's degree required; Master's degree preferred. EXPERIENCE REQUIREMENTS: * Three to five years of experience with grant writing, administration and implementing of grants. * Proven track record in obtaining grant funding through governmental (federal, state, other) and private entities/organizations. * Excellent written communication skills. * Excellent negotiating skills. * Excellent knowledge of grant processes and practices. * Profound knowledge of financial and budgeting aspects of the organization. * Must be a skilled administrative professional to carry out varied grant mandated job responsibilities * Must have client facing experience with strong verbal and written communication skills * Ability to maintain a cordial relation with different departments and with grantees or fund providers * Must be well organized and have a detail-oriented approach * Must have valid driver's license. SUPERVISORY RESPONSIBILITIES: Grant dependent. TRAVEL: Occasional local travel in Boston, South Shore and Plymouth campus may be required. Additional Information: EEO Statement: Quincy College is an equal opportunity employer committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy. Quincy College is committed to achieving a diverse workforce and complies with all Federal and Massachusetts State laws, regulations, and executive orders regarding non-discrimination and affirmative action. Application Instructions: Please submit the following documents online: * Resume * Cover Letter
    $54k-65k yearly est. 35d ago
  • Medical Writer III : 4710313

    Artech Information System 4.8company rating

    Medical writer job in Cambridge, MA

    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
    $79k-111k yearly est. 60d+ ago
  • Medical Writer - I

    Integrated Resources 4.5company rating

    Medical writer job in Raynham, MA

    A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. This is Contract position with my direct client Job Description Overview: The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences. Key Job Activities: Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies). Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups. Performs scientific writing (e.g. abstracts, manuscripts, presentations). Organizes and incorporates information for documents, such as references, graphics, tables, and data listings. Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates. Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence Independently, critically writes and edits scientifically complex documents for substantial intellectual content. Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals. Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices. Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users. Communicates with various departments (e.g. Regulatory, Product Development, Clinical Research, Quality) to identify the necessary clinical and technical information. Qualifications Job Qualifications Education Ph.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g. medical writing, regulatory affairs, clinical research, engineering) BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experience Knowledge/Requirements Excellent English language skills, especially writing and proofreading. Clinical, scientific or research background, highly preferred. Experience writing CERs, highly preferred. Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred. Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred. Expert understanding of scientific or clinical research and methods. Understanding of statistical data and good data management practices. Strong oral communication, presentation, project management and prioritization skills. Excellent interpersonal relationships. Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager). Additional Information Contact me at 732 549 5307
    $82k-117k yearly est. 60d+ ago
  • Grant Specialist

    Internships.com 4.1company rating

    Medical writer job in Boston, MA

    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.
    $56k-77k yearly est. 7h ago
  • Copywriting Intern

    Connelly Partners 3.5company rating

    Medical writer job in Boston, MA

    Job DescriptionSalary: $15.00/Hour Creative Department: Copywriting Intern Humble? Hungry? Care about ideas that actually move people? Were looking for aCopy Internwhos excited to learn, collaborate, and make work that matters. Please send a resume and a link to your online portfolio with spec work that shows conceptual thinking. CONNELLY CONTENT STUDIO: We make stuff. Social stuff. Timely stuff. Stuff people WANT in their feeds. Not ads preaching. But authentic content. Sometimes useful. Sometimes funny. Always relevant. We entertain, delight and educate on behalf of the brands we serve. Were scrappy. We write, design, shoot, edit, and animate stuff ourselves. Were ideas first, make it second. We try stuff with no fear of failure. Because the more we try, the more we learn. Together. We are the CP Content Studio. A nimble and hungry intern group specializing in design, photography, writing, video, and visual arts. Our goal is to make social content for brands that will resonate with their social audience. Each week, well pick a CP client to audit their and competitors social channels. From Titleist, to Gordons, to Unos and beyond. Initially, well generate droves of written ideas and discuss as a group with the Creative Director. Then, well pick some of them to bring to life. Well shoot, edit and comp stuff up. With the singular goal of generating audience engagement to help our clients businesses. And have a blast in the process. INTERNSHIP OVERVIEW: As a Content studio intern, youll join the creative team to create content and play a role in the entire production process. With guidance and mentorship from the Creative Director, youll collaborate with other members of the content studio to create compelling concepts, meaningful connections and relevant and innovative work while gaining hands on experience working on several established brand clients. ESSENTIAL JOB DUTIES: Ensure the creative vision and brand voice is implemented Assist in the development of ideas that stem from empathetic insights, cultural observations and timely social topics of discussions Write videos, social post content ideas, headlines and post copy Think conversationally and systematically understanding social content as a back and forth between a brand and consumers Work with art directors, photographers, videographers, other members of the team to frame your ideas Present your own ideas with confidence WHO WE'RE LOOKING FOR: Currently enrolled in a copywriting/advertising program Conceptual thinker who is able to think both in terms of words and visuals and how they work together to solve real marketing problems Excited to bring many ideas forward and see them through Team player **Portfolio required for this position**
    $15 hourly 31d ago

Learn more about medical writer jobs

How much does a medical writer earn in Cambridge, MA?

The average medical writer in Cambridge, MA earns between $66,000 and $141,000 annually. This compares to the national average medical writer range of $63,000 to $137,000.

Average medical writer salary in Cambridge, MA

$96,000

What are the biggest employers of Medical Writers in Cambridge, MA?

The biggest employers of Medical Writers in Cambridge, MA are:
  1. Google via Artech Information Systems
  2. Integrated Resources
  3. Beone Medicines
  4. Candel Therapeutics
  5. Costello Medical
  6. Praxis Precision Medicines
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