101 associate director medical writing jobs found

Job Description Job Description Job Title: Associate Director, Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and...

Job Description Job Description Job Title: Associate Director, Medical Writing Job Location: Cambridge, MA, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level 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...

Associate Director, Medical Writing Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners, and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. The...

The Associate Director, Medical Writing will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, administrative letters, and other regulatory submissions as needed. Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents. Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs. Facilitate comment...

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. Position Purpose: The Associate Director, Medical Writing will prepare, author, and complete regulatory documents necessary to ultimately support submissions to global health authorities. The Medical Writer (MW), positioned in Regulatory Affairs, will closely partner with Clinical, Nonclinical, Pharmacovigilance, CMC, and DMPK to support the...

Title: Manager, Associate Director, Medical Writing Location: Remote Salary: K depending on experience Type: Embedded Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Associate Director, Medical Writing w/ 5+ years industry experience. If you want....

The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is an hybrid role typically requiring on-site presence at least 3 days per week. Responsibilities: Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs) Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports Provide oversight...

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...

Associate Director, Medical Writing - Neuroscience Full-time Client is a Large Pharmaceutical Company The Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Responsibilities include but are not limited to: Working on complex problems in which analysis of...

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,...

Position We are seeking an experienced, detail-oriented individual to work with our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independent lead authoring and editing of medical and regulatory writing deliverables that support the clinical portfolio. You will partner with colleagues within Medical Writing as well as with the Nonclinical, Clinical, & Regulatory teams to prepare high-quality, accurate and concise documentation supporting the objectives of both teams and leadership. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York (NY), or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are an experienced, independent, scientifically minded individual with a passion for accurate...

Employer Industry: Biotechnology Why consider this job opportunity: Salary up to $195,000 per year Comprehensive benefits and work-life resources including physical and emotional wellness, financial wellness, and support for caregivers Opportunity for career advancement and growth within a leading biotechnology company Flexible remote work arrangement with occasional on-site requirements Chance to contribute to groundbreaking advancements in genetic medicine and patient care What to Expect (Job Responsibilities): Plan, prepare, write, edit, format, and finalize clinical and regulatory documents, including clinical protocols and study reports Represent Medical Writing on project teams, advising on content and format requirements for documents Coordinate deliverables with external vendors and ensure compliance with regulations Lead efforts to identify and resolve compliance or efficiency gaps in processes Provide mentoring and support for the development and training of direct...

RBW is partnered with a very exciting mid-sized biotech located in NYC. They are looking to add a talented Medical Writer to their team on a full-time basis. You will be reporting to the Head of Medical Writing and have significant room for growth. Must-have requirements: Willingness to be hybrid in NYC Seniority level Mid-Senior level Employment type Full-time Job function Science and Research Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr

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...

Our client, a leading oncology mid-sized pharma company, is seeking to recruit an experienced and hands-on medical writer to join their team remotely. As an Associate Director of Medical Writing, you'll play a critical role in drug development by providing leadership on clinical and regulatory documents. Key Responsibilities: Lead authorship: The successful candidate will have extensive experience working as lead authors on Common Technical Document (CTD), Investigational New Drug Application (INDA), Biologics License Applications (BLAs), and New Drug Applications (NDAs). We are looking for someone with 8+ years' experience. Hands-On Experience: You should be able to demonstrate that your previous work has been mostly hands-on and not just supervisory or managerial responsibilities. Sector Knowledge: Experience within Pharma/Biotech/CROs. Experience in oncology is required. Educational Qualification: Ph.D./MD/MS degree holders preferred; however, education can vary...

Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) in Cheyenne, Wyoming Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview The Associate Director, Medical Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. In this role, individuals are responsible for medical affairs...

Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) Helena, Montana Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview The Associate Director, Medical Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. In this role, individuals are responsible for medical...

Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ). Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) in Baton Rouge, Louisiana Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website...

Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) Charleston, West Virginia Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview The Associate Director, Medical Affairs Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. In this role, individuals are...

Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) Lincoln, Nebraska Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website here or follow us on LinkedIn . Job Overview The Associate Director, Medical Affairs Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive...

Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ). Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) in Des Moines, Iowa Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview The Associate Director, Medical Strategy...

Sumitomo Pharma Associate Director, Medical Affairs Strategy (Hematology/Oncology) Honolulu, Hawaii Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview The Associate Director, Medical Affairs Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. In this role, individuals are responsible for...

Job Description Job Description Title: Associate Director, Project Management (Medical Affairs) Location: Brisbane, CA/Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical...

Job Description Summary Associate Director, Innovation R&D is responsible for using their broad technical expertise, leadership skills, and medical device development process knowledge to drive and support innovation and concept phase projects. In this role, you will work with internal and external teams to progress infusion system technology, establish intellectual property to protect infusion system technology, and establish the infusion system R&D technology roadmap based on a strong understanding of technology capability, customer desirability, and financial viability. You will pursue multiple innovation opportunities in parallel, including incremental, architectural, disruptive, and radical innovation. You are expected to translate voice of customer and stakeholder needs into early stage concepts to test and iterate with users, identify key prioritized concept related system/product requirements, establish concept system architecture, proactively identify technical...