190 associate director medical writing jobs found

Who We Are Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs. Position Description Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents, in compliance with applicable guidelines and regulations. The successful candidate should be able to effectively collaborate with...

Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Rising above the status quo takes a team as strong as its science, and we hire and work by five values: accountability — owning outcomes and acting like owners; transparency — talking straight and building trust; collaboration — achieving together what no one could alone; innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission. Position Overview As we advance deupirfenidone (LYT-100) through Phase 3 toward...

The Company: A clinical-stage biotechnology organization focused on aging, and age-related diseases. The Role: The full-time Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents, in compliance with applicable guidelines and regulations. The successful candidate should be able to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a positive team environment. This role will function as a strong project manager and technical leader with demonstrated scientific and stakeholder-focused leadership skills. Responsibilities Provides medical writing leadership for clinical programs Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and...

Associate Director, Medical Writing - Neuroscience 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 support and direction to staff and contractors on these programs. As the lead writer, the incumbent ensures the timely completion, accuracy, and quality of all clinical and submission documentation throughout the compounds' lifecycle. Due to program complexity, the incumbent must quickly acquire comprehensive knowledge of the compounds to ensure consistency across studies. The candidate should have proven ability to manage outsourcing of document preparation and coordinate with service providers. Responsibilities include but are not limited to: Analyzing complex problems requiring in-depth evaluation of data and situations Preparing and sometimes directing the writing of PCSs, protocols, and amendments Preparing...

Job Description Job Description About BlossomHill Therapeutics: BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS...

Job Description Job Description Title: Associate Director, Medical Writing Location: Preference for candidates within commuting distance of Thousand Oaks, CA or the San Francisco Bay Area. Remote considered. Position Summary Latigo is seeking an experienced and highly motivated Associate Director, Medical Writing to join our Clinical Development organization. This hands-on role will be responsible for authoring and managing key clinical and regulatory documents, with a primary focus on clinical study protocols, protocol amendments, and clinical study reports (CSRs) supporting our growing development portfolio. The successful candidate will work cross-functionally with Clinical Development, Clinical Operations, Statistics, Clinical Pharmacology, Regulatory Affairs, and other stakeholders to ensure the timely delivery of high-quality, scientifically rigorous, and regulatory-compliant documents. In addition, this individual will help establish and maintain medical...

Description The Associate Director, Medical Writing & Scientific Communications will be a key member of the Medical Affairs organization, responsible for developing and executing strategic scientific communication initiatives that support clinical development, medical affairs priorities, and commercial launch readiness. In this role, the Associate Director will lead the creation of high-quality, scientifically rigorous medical communications across publications, congress activities, scientific platforms, advisory boards, and healthcare provider engagement initiatives. The ideal candidate brings deep expertise in medical writing and scientific communications within the biotechnology or pharmaceutical industry, demonstrated ability to translate complex clinical data into meaningful scientific narratives, and experience collaborating cross-functionally with Medical Affairs, Clinical Development, Regulatory Affairs, and external scientific experts. This is a unique opportunity to...

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. The Sr. Manager, Medical Writing plays a key role in supporting clinical development, regulatory submissions, and scientific communications across Artiva Biotherapeutics. Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a...

Structure Therapeutics seeks an Associate Director of Medical Writing to lead development of regulatory and clinical documents for its drug pipeline, supporting cardiovascular, metabolic, and pulmonary indications. This role partners with Clinical Sciences, Regulatory Affairs, Biostatistics, and others to ensure high-quality submissions. The position emphasizes compliance with FDA/EMA/ICH standards, document management best practices, and cross-functional leadership, with a remote-first setup #J-18808-Ljbffr

Role Associate Director of Medical Writing leading the development of regulatory and clinical documents for Structure Therapeutics' drug pipeline, primarily supporting cardiovascular, metabolic, and pulmonary indications. Responsibilities authoring, reviewing, and finalizing documents such as Study Protocols, Study Reports, Investigator Brochures, and regulatory responses; ensuring compliance with FDA, EMA, ICH standards; conducting QC reviews for accuracy, formatting, and data integrity; managing multiple projects and cross-functional collaboration with Clinical Sciences, Regulatory Affairs, Biostatistics, and others; providing strategic guidance on document standards and best practices. Requirements BA/BS or advanced degree in life sciences or pharmacy; 5+ years of regulatory medical writing experience within pharma or biotech; strong knowledge of global regulatory guidelines; proven ability to produce and QC high-quality regulatory documents; excellent communication,...

Structure Therapeutics is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. The role requires expertise in regulatory writing, QC, and cross‑functional collaboration to ensure compliant, timely submissions. You will manage multiple projects, mentor writers, and align messaging across documents while partnering with Clinical Sciences, Regulatory Affairs, Biostatistics, and other teams. #J-18808-Ljbffr

About Us Structure Therapeutics develops life‑changing medicines for patients using advanced structure‑based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‑stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. About Us Structure Therapeutics develops life‑changing medicines for patients using advanced structure‑based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome...

Job Description Job Description Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview Rhythm is seeking an experienced, highly motivated Associate Director of Medical Writing (MW) to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle. Reporting to the Head of Medical Writing, this role will partner with cross-functional stakeholders to advance...

About Us Structure Therapeutics develops life‑changing medicines for patients using advanced structure‑based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‑stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top‑tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and...

IQVIA seeks an Associate Director of Medical Writing to shape and drive the medical writing strategy across therapeutic areas. You will serve as a strategic partner to senior clinical leadership and oversee high-quality, strategically aligned deliverables that support regulatory submissions and lifecycle management. The role has global responsibilities, with potential for global reports and interaction with regulatory agencies across regions. Strong leadership and CTD expertise are required. #J-18808-Ljbffr

Role Associate Director of Medical Writing leading the development of regulatory and clinical documents for Structure Therapeutics' drug pipeline, primarily supporting cardiovascular, metabolic, and pulmonary indications. Responsibilities authoring, reviewing, and finalizing documents such as Study Protocols, Study Reports, Investigator Brochures, and regulatory responses; ensuring compliance with FDA, EMA, ICH standards; conducting QC reviews for accuracy, formatting, and data integrity; managing multiple projects and cross-functional collaboration with Clinical Sciences, Regulatory Affairs, Biostatistics, and others; providing strategic guidance on document standards and best practices. Requirements BA/BS or advanced degree in life sciences or pharmacy; 5+ years of regulatory medical writing experience within pharma or biotech; strong knowledge of global regulatory guidelines; proven ability to produce and QC high-quality regulatory documents; excellent communication,...

Remote - must be located in the United States - West Coast hours required Associate Director, Medical Writing (Regulatory) The Director of Medical Writing will serve as a strategic and scientific leader within the organization, responsible for driving the development and delivery of high-quality regulatory documents across multiple programs. This role operates as a senior individual contributor with leadership responsibilities, reporting into the Head of Regulatory & Medical Writing. While the position can be performed remotely, candidates based in or near San Diego are preferred. Key Responsibilities Lead the authoring and end-to-end development of complex regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures, briefing packages, and global marketing application summaries (e.g., CTD Module 2). Act as the medical writing representative on cross-functional program teams, providing strategic input on clinical and regulatory...

Remote - must be located in the United States - West Coast hours required Associate Director, Medical Writing (Regulatory) The Director of Medical Writing will serve as a strategic and scientific leader within the organization, responsible for driving the development and delivery of high-quality regulatory documents across multiple programs. This role operates as a senior individual contributor with leadership responsibilities, reporting into the Head of Regulatory & Medical Writing. While the position can be performed remotely, candidates based in or near San Diego are preferred. Key Responsibilities Lead the authoring and end-to-end development of complex regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures, briefing packages, and global marketing application summaries (e.g., CTD Module 2). Act as the medical writing representative on cross-functional program teams, providing strategic input on clinical and regulatory...

Remote - must be located in the United States - West Coast hours required Associate Director, Medical Writing (Regulatory) The Director of Medical Writing will serve as a strategic and scientific leader within the organization, responsible for driving the development and delivery of high-quality regulatory documents across multiple programs. This role operates as a senior individual contributor with leadership responsibilities, reporting into the Head of Regulatory & Medical Writing. While the position can be performed remotely, candidates based in or near San Diego are preferred. Key Responsibilities Lead the authoring and end-to-end development of complex regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures, briefing packages, and global marketing application summaries (e.g., CTD Module 2). Act as the medical writing representative on cross-functional program teams, providing strategic input on clinical and regulatory...

Remote - must be located in the United States - West Coast hours required Associate Director, Medical Writing (Regulatory) The Director of Medical Writing will serve as a strategic and scientific leader within the organization, responsible for driving the development and delivery of high-quality regulatory documents across multiple programs. This role operates as a senior individual contributor with leadership responsibilities, reporting into the Head of Regulatory & Medical Writing. While the position can be performed remotely, candidates based in or near San Diego are preferred. Key Responsibilities Lead the authoring and end-to-end development of complex regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures, briefing packages, and global marketing application summaries (e.g., CTD Module 2). Act as the medical writing representative on cross-functional program teams, providing strategic input on clinical and...

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com. 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...

A leading pharmaceutical company is seeking a Principal Medical Writer Associate Director.This remote position involves creating regulatory-compliant clinical documents, leading digital innovations, and managing project initiatives.Candidates should have over six years of experience in medical writing, strong regulatory expertise, and the ability to work within global teams.Competitive compensation and a comprehensive benefits package are offered.#J-18808-Ljbffr.

Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients. Position Description The Opportunity Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as: Clinical study protocols and clinical protocol amendments Clinical study reports Investigator’s brochures and annual...

General Description: We are seeking a highly experienced and strategically minded Medical Writer to lead the development and execution of global health economics and outcomes research (HEOR) publications across our oncology portfolio. This role will translate complex health economic, real-world evidence (RWE), patient-reported outcomes (PRO), healthcare resource utilization (HCRU), and outcomes research data into clear, scientifically rigorous, and high-impact publications and congress materials. The Associate Director will partner with HEOR, Market Access, Medical Affairs, Clinical Development, Biostatistics, Evidence Generation, and external experts to ensure timely dissemination of evidence supporting the clinical, economic, and patient-centered value of BeOne Medicines therapies. The role will help shape the external scientific narrative and support evidence-based healthcare decision-making globally. This is an individual contributor, remote position. Essential Functions of...