33 associate director medical writing jobs found in New York, NY

Leading the planning and delivery of complex clinical and regulatory documents, the full-time Associate Director, Medical Writing will provide strategic leadership in regulatory submissions while collaborating with cross-functional teams, with the potential for remote work. Key responsibilities: Lead the development and authoring of regulatory documents such as clinical study reports and marketing application summaries Serve as the Regulatory Medical Writing lead on cross-functional program teams, ensuring high-quality documentation Provide strategic input into regulatory document planning and manage timelines for deliverables Required qualifications: Bachelor's degree required; advanced degree in a scientific or regulatory field preferred 12+ years of medical writing experience in the pharmaceutical industry, with proven lead writer experience for key regulatory documents Strong understanding of the drug development lifecycle and regulatory submission processes Extensive...

Remote - must be located in the United States - West Coast hours Associate Director, Medical Writing (Regulatory) The Associate 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...

Offering a remote contract opportunity, the Associate Director, Medical Writing - Publications will manage the writing and editing of high-quality medical documents for publication, oversee project management for therapeutic area publications, and engage with internal and external stakeholders to develop publication strategies. Key responsibilities Provide expert writing and editing support for medical/scientific documents intended for publication or presentation Manage and review data and source documents necessary for publication, including mock-up development for tables and figures Oversee outsourced medical writers and manage projects through the publication review system Required qualifications A PhD, MD, or PharmD with at least 5 years of relevant experience, or a Master's degree with a minimum of 8 years of experience in the pharmaceutical/scientific field Research experience in academia or the pharmaceutical industry is preferred Demonstrated ability to interpret and...

Summary This position will report to the Medical Writing Department Head and will lead scientific, medical and regulatory writing activities for development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs). The professional will also perform the medical writing, QC reviews, and editing of the documents and will be responsible for the management, planning and direction of a team of medical writers. The professional will ensure the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and...

To support the development of complex clinical and regulatory documents, the full-time Associate Director of Medical Writing will manage medical writing processes, ensuring compliance with standards while collaborating with cross-functional teams in a remote environment. Key responsibilities: Primary author of regulatory documents including protocols, IBs, and CSRs, ensuring accuracy and compliance Engages subject matter experts to develop high-quality content and facilitates standardization of documents across programs Manages a team of medical writers and oversees multiple projects to meet corporate objectives and deadlines Required qualifications: Bachelor's degree in a scientific or clinical discipline; PhD preferred Minimum of 5 years of clinical/regulatory medical writing experience in pharma or biotech Fluent in American English with strong writing and proofreading skills Experience with eCTD Module 5 and Module 2 writing for global marketing applications Basic...

EVERSANA INTOUCH® is a global, full-service marketing agency network serving the life sciences industry, and is the first – and only – agency network to be part of a fully integrated commercialization platform through EVERSANA®. We provide next‑generation creative and media services, enterprise solutions, and data analytics services for clients. We get fired up when people talk about getting—and staying—healthy. That’s where we find our inspiration: in the very human experiences of patients, doctors, and even each other. Then, we collaborate on ways to make caring for one’s health more achievable, connecting patients and physicians with the information and tools they need. We embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an...

Associate Director, Medical Strategy At Real Chemistry, making the world a healthier place isn’t just an aspiration—it’s our everyday reality. Our drive to transform healthcare is informed by our blend of deep scientific expertise, human‑centred creativity, and AI‑driven insights, fostering a unique environment where innovation thrives and our people are impact‑obsessed. Our culture is rooted in our people – we believe we are best together and are committed to excellence for both our clients and colleagues. Whether you’re a seasoned professional or just starting your career, if you share our passion for healthcare and connection, we invite you to explore our opportunities. This is a hybrid role, based in any of our US offices (New York City, Boston, Chicago, Carmel, or San Francisco) or remotely within the US, depending on team and business needs. What You’ll Do Therapy area and scientific expertise – Guide teams, contribute through others, and co‑create excellent medical...

A global marketing agency in New York is seeking an Associate Director, Medical to drive strategic recommendations and develop scientific content. The ideal candidate has an advanced degree, at least two years of agency experience, and a strong background in medical writing. Responsibilities include guiding educational content creation, conducting literature searches, and fostering client relationships. This role involves working collaboratively with internal teams to develop impactful, data-driven programs that address complex health challenges. #J-18808-Ljbffr

Title: Associate Director Medical Writer Location: REMOTE Duration: 24+ months (Possibility of extension) Schedule: Initially, only ~15-25 hours per week are utilized for onboarding and training. If performance is strong, this position could be full time. Responsibilities The primary responsibilities of an Associate Director Medical Writer include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product...

Overview $20,000 Hiring Bonus!! Monthly and Quarterly Bonus Incentives! Through our evidence-based medicine approach, Concentra's goal is to provide quality patient care while treating everyone with friendliness, skill, and respect. We strive daily to promote a diverse environment of acceptance and compassion for our colleagues and cultivate a welcoming atmosphere where our patients can heal. As we've grown, we've expanded into urgent care, wellness services, administration, onsite health and wellness centers, and telemedicine. All these services together make achieving health easier and more accessible for our patients, clients, colleagues, and all provide you with unmatched support, education, career advancement opportunities, and benefits. The Associate Director of Medical Operations position involves providing direct patient care and leading by example to ensure an exceptional patient experience. The role includes identifying and communicating opportunities for clinical...

Eastridge is seeking a highly skilled Medical Writer III at the Associate Director level to join a remote team supporting drug development programs. This position focuses on leading medical writing initiatives and preparing regulatory documents across therapeutic areas. The ideal candidate will have a PhD or MS in Life Sciences along with significant experience in medical writing and familiarity with regulatory guidelines. Join us to make an impact in advancing new therapies. #J-18808-Ljbffr

PRIME Education, a property of Everyday Health Group, seeks an Associate Director to lead end-to-end grant development and content creation for awarded grants. This fully remote role requires independence, strong medical writing, educational design, and grant development to cultivate ongoing grant opportunities. The role interfaces with senior faculty and the Scientific Affairs Department, ensuring AMA-compliant content and impact evaluation across initiatives. #J-18808-Ljbffr

Associate Director - Medical Review (Plainsboro, NJ Or Remote)The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization.From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.The one thing that keeps us all marching to the same beat is our patient-centered focus.At Novo Nordisk, you will help patients around the world.As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life.We're changing lives for a living.Are you ready to make a difference?The PositionResponsible for performing medical review and validation of incoming adverse events, ensuring the correct medical interpretation, including evaluation of expectedness and reportability.Ensures consistency in the evaluation...

At Houston Methodist, the Lead Outpatient Coder position is responsible for providing administrative support to the department while ensuring diagnostic and procedure codes are assigned accurately to outpatient encounters based on documentation within the electronic medical record and maintaining compliance with established rules and regulatory guidelines. This position serves as the liaison between management, staff and physicians for routine matters, resolving questions and issues. Duties may be varied and may include many of the following: organize work schedules, create work assignments, review timecards for accuracy, conduct quality assurance audits of staff performance, develop and implement quality improvement activities, train and mentor staff, provide feedback on staff performance and developmental needs, collect/analyze/report on data, prepare reports on performance and metrics, and other responsibilities of a similar nature and level. FLSA STATUS Non-exempt...

## Associate Director, Ophthalmology HCP Medical Education MarketingApplyremote type: Hybridlocations: USA - Pennsylvania - North Wales (Upper Gwynedd)time type: Full timeposted on: Posted Todaytime left to apply: End Date: July 16, 2026 (7 days left to apply)job requisition id: R399964**Job Description**Our US Ophthalmology team is committed to transforming the lives of patients living with diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) with a portfolio of two products in the pipeline. We aspire to achieve this through a relentless commitment to patients, innovation, ensuring access to life‐changing therapies, and collaborating with healthcare systems, governments, and payers to make treatments available to those who need them most. Our focus is on patients, scientific rigor, and flawless execution—bringing breakthrough therapies to those who need them.We are passionate about bringing our medicines and vaccines to customers around...

This is a remote 6‑month contract outpatient surgical coder role with a potential extension or permanent conversion. The client is located in the United States and the coder must be based in AL, AK, AR, AZ, DE, FL, GA, IA, ID, IL, IN, LA, KS, KY, ME, MI, MO, MS, MT, NC, ND, NE, NH, NM, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI, WV, or WY. Responsibilities Review coding denials to determine accurate coding, add additional codes if required, and correct denials without writing appeals. Focus on outpatient surgical coding within the facility. Perform 3‑5 reviews per hour to meet performance standards. Qualifications 2–5 years of hospital surgical coding experience Experience with outpatient coding CCS, CPC, RHIA or RHIT certifications Experience working with denials Advanced knowledge of medical terminology, anatomy, physiology, pharmacology, and coding guidelines Epic experience Job Details Seniority Level: Associate Employment Type: Contract Job Function: Quality...

Associate Director / Director, Medical Science Liaison Womens Health US-- Job ID: 2026-1902 # of Openings: 1 Category: Medical Science Liaison BESTMSLs Overview This field-based Medical Science Liaison role supports the Womens Health therapeutic area across the United States (exact territory to be determined), with a focus on engaging key opinion leaders (KOLs) and healthcare providers in high-quality scientific exchange. The Associate Director/Director will serve as a critical link between external stakeholders and the Medical Affairs organization, driving insight generation and contributing to the development and execution of medical strategy. This role requires deep expertise in Women's Health, including exposure to contraception, and a strong ability to translate complex clinical data into meaningful, actionable discussions. The individual will proactively identify unmet educational needs, deliver non-promotional scientific support, and play a key role in shaping medical...

BUILD OUR FUTURE TOGETHER: As an Associate Director, Field Medical Affairs (Medical Science Liaison) you will engage in the exchange of our scientific data and medical information with KOLs, HCPs, researchers, pharmacists and population-based decision makers. You will demonstrate a thorough understanding of B-Cell Malignancies (NHL and Multiple Myeloma) aligned with our strategic medical plans. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. WHEN & WHERE Territory: Texas with a focus on Houston and Dallas, New Mexico, Louisiana. Residency in the territory is required with a preference for Houston or Dallas. DISCOVER YOUR ROLE Identifying and maintaining a list of medical/therapeutic area experts, investigator targets and associated plans of action. Establishing, fostering, cultivating and maintaining relationships with KOLs in Hematological Malignancies. Act as the...

Overview Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of pioneering scientific innovations in muscle biology. The Associate Director, Clinical Quality Assurance (CQA) Auditor will serve as the primary auditor for GCP/GLP/GVP audits and the primary process owner of the CQA audit program. The role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local and ICH-GCP guidelines, driving and maintaining quality standards and a regulatory‑compliance culture at Cytokinetics. Responsibilities Serve as the CQA audit program process owner and manage day‑to‑day audit program activities, including audit coordination, report reviews, response reviews, CAPA follow‑up, and audit closures. Serve as the principal lead auditor for GCP, GVP, and GLP audits of investigator sites, CROs, vendors, laboratories, and internal functional areas. Develop, implement, and maintain a risk‑based global clinical...

The Center for Technology Licensing at Cornell University seeks an Associate Director for Business Development and Licensing with a focus on biomedical technology. Well-qualified candidates will possess prior experience assessing inventions, developing business, and negotiating contracts in the technology transfer field.The RoleAs Associate Director for Business Development and Licensing, you will contribute your forward-thinking perspective to a leadership team driving a comprehensive technology commercialization and partnership program. You will manage a large biomedical technology portfolio and serve as the primary liaison with faculty and research staff in designated research areas.Key responsibilities will include:Helping faculty and researchers crystallize inventive ideas and disclose inventions, tangible and copyrightable materials to the UniversityContinuously assessing business needs in target industries by establishing, maintaining, and growing business development...

Job Family :Strategy & Transformation ConsultingTravel Required :Up to 25%Clearance Required :NoneIs life sciences in your DNA? Breakthroughs in pharma are helping people live healthier lives, while medical devices enable patients to proactively maintain health - this is undoubtedly a transformative time for health care companies. Guidehouse's Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device, and diagnostic companies develop custom solutions that tackle today's challenges, while anticipating tomorrow's. You will have an immediate impact by partnering with our clients, across all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up for the challenge?We continuously strive to foster an inclusive and diverse work culture and thoughtfully develop our people through challenging work, valuable learning and educational programs. We...

Job Title: Associate Director of Medical Operations (ADMO) Location: Multi-site (Regional) Reports To: Director of Medical Operations Position Summary: The Associate Director of Medical Operations (ADMO) is a strategic and operational leadership role responsible for the medical quality, performance, development, and engagement of the DVM teams across a portfolio of hospitals. The ADMO will report to the Director of Medical Operations and will act as the direct link from Ethos medical leadership to the local medical teams.The ADMO partners with the Division Leader, Operational Support Manager, Hospital Directors, local Medical Directors and Regional Nursing Director to drive financial success through operational efficiencies and high-quality medicine.The ADMO supports Medical Directors in the region to ensure delivery of high-quality, evidence-based medicine while aligning medical initiatives with organizational goals. The ADMO serves as a coach, mentor, and resource for...

Overview As an Associate Director, Field Medical Affairs (Medical Science Liaison) at Regeneron, you will exchange scientific data and medical information with KOLs, HCPs, researchers, pharmacists and population-based decision makers across Tennessee, Alabama, Mississippi and Arkansas. Residency in the territory (preferable TN or AL) is required and you will travel approximately 70% of the time. Responsibilities Identify and maintain a list of medical/therapeutic area experts, investigator targets and associated plans of action. Establish, foster, cultivate and maintain relationships with KOLs in Hematological Malignancies. Serve as the primary clinical/scientific resource for disease state and product information, ensuring awareness and understanding. Participate in the development and management of company-sponsored clinical trials. Build scientific relationships with investigators and internal Medical Affairs to support investigator-initiated study (IIS) concept programs....

GoTo Telemed seeks an exceptional Remote Medical Biller to manage comprehensive Revenue Cycle Management (RCM) operations for our rapidly expanding telehealth platform serving multiple medical specialties and healthcare providers nationwide.As a key member of our distributed RCM team, you will process, manage, and optimize medical claims for an increasing portfolio of telehealth providers--with new clients and provider networks added every month as our organization scales.In this critical role, you will be the financial backbone of our provider network, managing the complete end-to-end billing lifecycle including patient eligibility verification, insurance claim submission, payment posting, accounts receivable follow-up, and comprehensive denial management.Your expertise in medical coding (CPT, ICD-10-CM, HCPCS), telehealth modifiers, payer policies, and compliance will directly impact provider revenue, patient satisfaction, and our organizational growth trajectory.This position...