183 associate director medical writing jobs found

Job Description General Summary The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities Independently authors routine and complex clinical and regulatory documents Provides strategic input into program-level plans Deep insight into how different...

Associate Director Medical Writing The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more programs within clinical development. You will be accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory submissions.

Associate Director, Medical Writing (Regulatory) Redwood City, California, United States 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. The Associate...

Job Description:If you are a current Jazz employee please apply via the Internal Career site.n Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to ntransform the lives of patients and their families. We are dedicated to developing nlife-changing medicines for people with serious diseases -- often with limited or no ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. nOur patient-focused and science-driven approach powers pioneering research and development nadvancements across our robust pipeline of innovative therapeutics in oncology and nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development nlaboratories, manufacturing facilities and employees in multiple countries committed to nserving patients worldwide. Please visitnwww.jazzpharmaceuticals.comnfor more information.n Brief Description: The...

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life‑changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient‑focused and science‑driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description The Associate Director,...

Title: Associate Director, Medical Writing Location: Remote Position Summary: We are seeking an Associate Director, Medical Writing who will report into the Executive Director of Clinical Science. You will be responsible for the creation, editing, and quality control of scientific, medical and regulatory documents. This role will also involve managing interactions with external consultants and clinical research organizations (CROs). Responsibilities: Write, review, edit, proofread, verify, and manage Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, NDA clinical modules, and other higher‑level regulatory documents. Contribute to document templates, style guides, and medical writing related SOPs. Conduct quality control (QC) checks to ensure accuracy, consistency, and compliance with regulatory requirements and Celcuity SOPs and Style Guide. Manage and coordinate communication with consultants and CROs. Other duties as assigned. Qualifications:...

Associate Director, Medical Writing page is loaded## Associate Director, Medical Writingremote type: Remotelocations: Remotetime type: Full timeposted on: Posted 30+ Days Agojob requisition id: JR000468Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of...

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 and...

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

A leading biopharmaceutical company in Pennsylvania is seeking an experienced Medical Writer to create regulatory documents and ensure compliance. Candidates should have a bachelor’s degree, with a PhD preferred, and a minimum of 5 years of relevant experience. Strong communication skills and proficiency in American English are essential. This position offers a competitive salary, comprehensive benefits, and remote work flexibility. #J-18808-Ljbffr

Why consider this job opportunity Salary up to $246,000 Opportunity to participate in short‑term and long‑term incentive programs Comprehensive benefits package, including retirement savings plans and health benefits Chance to contribute to innovative therapies that help autoimmune patients Collaborative work environment with a focus on professional growth Remote work flexibility available What to Expect (Job Responsibilities) Serve as the primary author for various regulatory documents, including protocols, IBs, and CSRs Collaborate with subject matter experts to ensure content is accurate and compliant Maintain inspection‑readiness for all medical writing activities Standardize documents using templates and style guides for consistency Manage and support medical writers and external vendors on regulatory submissions What is Required (Qualifications) Bachelor’s degree in a scientific or clinical discipline; PhD preferred Minimum of 5 years of sponsor‑level pharma or...

Associate Director/Director, Medical Writing Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary...

A global marketing agency in New York is seeking an Associate Medical Director to generate and oversee medical content for healthcare professionals. The ideal candidate will have a master's degree or higher in healthcare, at least four years of relevant experience in medical writing, and the ability to mentor junior staff. This role encompasses collaboration on educational materials and adherence to U.S. pharmaceutical regulations, ensuring content relevance and accuracy. #J-18808-Ljbffr

A leading global communications network is seeking an Associate Medical Director in New York. This role focuses on generating promotional content for healthcare professionals and requires a strong background in medical writing and mentoring. Ideal candidates hold a Master’s or Doctoral degree and have extensive experience in healthcare communications. The role offers a salary range of $79,990 to $125,925 annually, along with comprehensive benefits. #J-18808-Ljbffr

A biopharmaceutical company in Palo Alto is seeking an Associate Director, Global Medical Writing. The role involves writing scientific publications for clinical trials and requires extensive collaboration with internal teams. Candidates should have an MS/PhD or equivalent experience in scientific writing. Competitive salary range is $170-185k along with a comprehensive benefits package including 401(k), health insurance, and flexible spending accounts. #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...

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Global Medical Writing, will be responsible for writing scientific publications connected with Ascendis’ clinical trials in endocrine indications. The role involves extensive cross‑functional collaboration with internal...

Associate Director- Medical Affairs, Publication Mgmt As an Associate Director, Publications, you will play a strategic role in the development, management and dissemination of our Global publication plans. This includes the execution of publications including but not limited to clinical, HEOR/RWE, PKPD, and disease state. Responsibilities will include leading cross-functional publication teams to develop, manage, and implement publication plans for our therapeutic areas. You will be expected to participate in cross functional meetings, monthly core publication team meetings, present at regular strategic meetings, workshops and relevant alliance meetings needed to build and refine publication plans ensuring partners are aligned and updated. This position is located at our Sleepy Hollow, NY office with a requirement to be on-site 4 + days/week. If eligible, we can offer relocation benefits. We cannot offer a hybrid or fully remote option. Typical Day Partner in the development of...

Associate Director, Medical Communications – Oncology (Remote) If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more...

Compliance Auditor page is loaded## Compliance Auditorlocations: AK - Juneautime type: Full timeposted on: Posted Yesterdayjob requisition id: JR102042Pay Range:Pay Range:$47.69 - $67.19SEARHC is a non-profit health consortium which serves the health interests of the residents of Southeast Alaska. We see our employees as our strongest assets. It is our priority to further their development and our organization by aiding in their professional advancement.Working at SEARHC is more than a job, it’s a fulfilling career. We offer generous benefits, including retirement, paid time off, paid parental leave, health, dental, and vision benefits, life insurance and long and short-term disability, and more.Ensure SEARHC meets federal and state regulations and internal policies in regard to healthcare coding, documentation, and billing practices. Review health records to verify coding and clinical documentation meets applicable coding and billing requirements, Medicare/Medicaid...

Associate Director, Medical Affairs Harrow (Nasdaq: HROW) is a leading North American ophthalmic-focused pharmaceutical company. Harrow is an incredible entrepreneurial company where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of! Harrow's...

Associate Director, Medical Affairs Harrow (Nasdaq: HROW) is a leading North American ophthalmic-focused pharmaceutical company. Harrow is an incredible entrepreneurial company where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of! Harrow's...

Overview Fresno County is the heart of California! Fresno offers outdoor adventures, family-friendly activities, and farm to table dining. The sun shines for more than 300 days of the year, creating the perfect environment to enjoy Concentra's work life Balance. We look forward to speaking with you! Receive $50K when you sign with Concentra! Plus Bonus Potential! Monthly and Quarterly Bonus Incentives! Through our evidenced 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,...

Associate Director, Medical Affairs Harrow (Nasdaq: HROW) is a leading North American ophthalmic-focused pharmaceutical company. Harrow is an incredible entrepreneurial company where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of! Harrow's...