62 associate director medical writing jobs found

Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other . People are at the center of everything we do, and when it comes to our employees, we make it personal . With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity tocontribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves. Join us, as we reshape the future. The Associate Director, Medical Writing, will provide writing...

Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. *Relocation support will be considered for this role Overview of Role: The Associate Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Role and Responsibilities: Prepare & edit clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed. Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug...

Associate Director, Medical Writing United States - California - Foster City United States – Remote United States - New Jersey - Parsippany Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Making an impact on a global scale Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet...

Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group. The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents. Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness. Job Summary The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents . The “hands-on” Medical Writer is responsible for preparing clinical summary documents,...

Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. *Relocation support will be considered for this role Overview of Role: The Associate Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Role and Responsibilities: Prepare & edit clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug...

Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. *Relocation support will be considered for this role Overview of Role: The Associate Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Role and Responsibilities: Prepare & edit clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug...

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and...

Job Description Job Description Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio...

Planet Pharma's client is looking for an Associate Director / Senior Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according standards. Key Accountabilities/Responsibilities: Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents Author clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and that complies with applicable company SOPs,...

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over...

Planet Pharma's biopharma client is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department. This individual will contribute to and execute the overall strategy for all medical writing processes to according medical writing standards standards and corporate objectives. Roles and Responsibilities: Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents Author clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and that complies with applicable company SOPs, style guide, lexicon, templates, and libraries May include roles that are key...

We’re explorers, optimists, scientists, engineers, inventors, technologists, drug developers and more, working together to make a difference in peoples’ lives. Science. Freedom. Community We are curious by nature. We love science and have the sense of wonder that is required to succeed in a diverse area of discovery such as aging. We’re excited and humbled by the opportunity. We are deliberate about creating a community in which Calico scientists and engineers have the freedom to explore, take chances and follow their own scientific pursuits and passions, wherever they may lead. We focus intensely on interdisciplinary collaboration within Calico, and with our external partners, because we believe that breakthroughs occur when curious people work together to solve what others believe are intractable challenges. Take a look at our available job opportunities Calico is proud to be an equal opportunity workplace. Please note: Calico does not contact people regarding jobs that...

About Us: Nkarta ?is a publicly traded ( Nasdaq ?symbol? NKTX ) , biotechnology company headquartered in South San Francisco focused on the discovery, development and manufacturing of off-the-shelf, natural killer (NK) cell therapies. Our near-term goal is to bring cell therapy out into the community setting, dramatically expanding access for patients. Founded in 2015 at the birthplace of biotechnology, Nkarta is a fast-growing, fast-moving, clinical-stage company that has built an extensive cell therapy manufacturing operation in anticipation of product commercialization. Our developmental pipeline of engineered NK cell therapies includes clinical programs in B-cell malignancies and autoimmune diseases. Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation. We recently built out a 23,000-square foot clinical good manufacturing practice, or cGMP, facility on-site at our...

As an Associate Director of Medical Information you will lead and supervise a core function providing accurate, unbiased, balanced and timely response to unsolicited medical inquiries regarding Regeneron marketed and development products. These responses will be directly to health care professionals, patients, clinical sites and managed care organizations. Our Medical Information provides the perspective and expertise to develop necessary policies and procedures that are in accordance with industry standards and appropriate regulations/guidelines relating to medical information and communication. This position will be onsite for 3+ days/week at our Sleepy Hollow, NY offices. If eligible, we can offer relocation benefits. A typical day may include the following: Oversees the outsourced Medical Information Contact Center. Responds to raised medical information requests from the contact center in a timely fashion. Manages medical Inquiry tends/metrics, quality, quantity, and...

Associate Director, Medical Content Strategy & Enablement Associate Director, Medical Content Strategy & Enablement locations United States - California - Foster City time type Full time posted on Vor 3 Tagen job requisition id R0044805 At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a...

Job Description Job Description Company Description A well-established and growing Medical Billing company based in Downtown Orlando and is currently looking for an experienced account manager to join its growing team.   Job Description The Senior Biller Manager would directly report to the Director of Operations. The Senior Biller Manager would be responsible for managing client accounts to coordinate their overall functions of billing, maximizing cash flow while improving patient, physician, and other customer relations. Requires STRONG  leadership and business office skills, including project management, critical thinking and analytical skills. This is a full-time and In-person position only Qualifications ·         Preferred 4+ years’ experience in a medical office reimbursement department ·         Preferred a minimum of 3 years’ supervisory or management experience over staff. ·         Experience with EMR Management software ·         Strong background in...

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. Associate Director, Medical Information, Endocrinology Responsibilities: Vendor Management...

Company Description A well-established and growing Medical Billing company based in Downtown Orlando and is currently looking for an experienced account manager to join its growing team. Job Description The Senior Biller Manager would directly report to the Director of Operations. The Senior Biller Manager would be responsible for managing client accounts to coordinate their overall functions of billing, maximizing cash flow while improving patient, physician, and other customer relations. Requires STRONG leadership and business office skills, including project management, critical thinking and analytical skills. This is a full-time and In-person position only Qualifications •Preferred 4+ years' experience in a medical office reimbursement department •Preferred a minimum of 3 years' supervisory or management experience over staff. •Experience with EMR Management software •Strong background in Accounts Receivable •Experience in CPT and ICD10 codes, HCFA 1500 and...

Discover Your Career at Emory University: Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community. Description: The Associate Director, Research Projects-School of Medicine, Hematology Medical Oncology, serves as Key Personnel and leads a program for a research study funded by the National Institutes of Health to promote a more diverse future STEM and biomedical research workforce by involving K-12 students in informal science education programs (after school and summer). The program utilizes national and statewide Cancer Big Data and principles of Artificial Intelligence to solve real community cancer-related problems. The program investigates interventions to increase underrepresented populations in STEM careers. Data are collected to evaluate student changes in program...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: As a new member of the Revolution Medicines team, the Associate Director, Medical Communications Operations will provide operational leadership for the execution of medical publications and scientific communication strategies. This role will oversee the use and optimization of publications management systems, manage cross-functional collaboration, and ensure efficient execution of medical communication...

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . GRAIL is seeking an Associate Director of Medical Communications to join the Medical...

Company Description A well-established and growing Medical Billing company based in Downtown Orlando and is currently looking for an experienced account manager to join its growing team. Job Description The Senior Biller Manager would directly report to the Director of Operations. The Senior Biller Manager would be responsible for managing client accounts to coordinate their overall functions of billing, maximizing cash flow while improving patient, physician, and other customer relations. Requires STRONG leadership and business office skills, including project management, critical thinking and analytical skills. This is a full-time and In-person position only Qualifications •Preferred 4+ years' experience in a medical office reimbursement department •Preferred a minimum of 3 years' supervisory or management experience over staff. •Experience with EMR Management software •Strong background in Accounts Receivable •Experience in CPT and ICD10 codes, HCFA...

Clinical Coder III - Department of Neurosurgery Job no: 532862 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Office/Administrative/Fiscal Support, Veteran's Preference Eligible, Health Care Administration/Support Department: 29190000 - MD-NEUROLOGICAL SURGERY Classification Title: Clinical Coder III Job Description: The Department of Neurosurgery is seeking an experienced surgical coder to perform highly specialized diagnosis and procedural coding for all operative procedures and inpatient consulting services performed by the faculty of the Department of Neurological Surgery including those performed in Gainesville and at Halifax Regional Medical Center. The ideal candidate will have a thorough knowledge of anatomy, surgical and medical terminology coding, a working knowledge of the billing requirements of insurance carriers, and the operating procedures of the department and the hospital(s). The Lillian S. Wells...