11 associate director medical writing jobs found in Cambridge, MA

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...

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...

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,...

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...

Job Description General Summary The GMP Operational Associate Director is recognized as an expert internally in the principles and application of quality assurance and compliance. The GMP Operational Associate Director will provide QA support of manufacturing operations, oversee sterilization processes and microbiological testing, and serve as a Product Quality Lead for the activities supporting Cell & Genetic Therapies. The GMP Operational Associate Director should excel in an environment that embraces teamwork, change, risk-based decision making, and flexibility. This individual should be willing to make a significant contribution to a multi-disciplinary team, must be self-motivated to take action, and have excellent written and verbal communication skills. The qualified candidate will provide quality assurance support for quality systems and compliance activities, working cross-functionally with R&D, Product/Process Development, Manufacturing, Supply Chain, QC, and QA....

Become a part of our caring community and help us put health first The Senior Provider Reimbursement Professional (MCCAU Code Edit Policy Team)-Certified Medical Coder performs research, analysis, documentation, and interpretation for the provider reimbursement programs for an organization that provides health insurance. The Senior Provider Reimbursement Professional work assignments involve moderately complex to complex issues where the analysis of situations or data requires an in-depth evaluation of variable factors. The Senior Provider Reimbursement Professional - Certified Medical Coder (MCCAU Code Edit Policy Team) updates, maintains, and reviews fee scheduling and pricing structures. Ensures contracted rates and reimbursement policies are priced and applied accurately. Identifies reimbursement policy and process recommendations and ensures compliance with government regulations. Analyzes provider reimbursement patterns and trends. Begins to influence department’s strategy....

Company : Allegheny Health Network Job Description : GENERAL OVERVIEW: Performs all related internal, concurrent, prospective and retrospective coding audit activities. Reviews medical records to determine data quality and accuracy of coding, billing and documentation related to DRGs, APCs, CPTs and HCPCS Level II code and modifier assignments, ICD diagnosis and procedure coding, DRG/APC structure according to regulatory requirements. Reports findings both verbally and in writing and communicates results to affected areas. Uses information to generate topics for education, training, process changes, risk reduction, optimization of reimbursement with new and current coders in accordance with coding principles and guidelines. Promotes cooperation with CDMP and compliance programs to improve documentation which supports compliant coding. Interacts with external consultants regarding billing, coding and/or documentation and evaluates their recommendations and/or teaching plans in...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objectives/Purpose The Associate Director, Global Medical Communications, Immunology is a key strategic partner of the Global Medical Affairs team, responsible for dynamically driving the strategic planning and tactical execution of the comprehensive medical communications plan as a central component of the global medical strategy for assigned assets. In strategic partnership with cross-functional stakeholders, the Associate Director, Global Medical Communications, Immunology will: Lead the planning and execution of the integrated congress plans including oversight of content for and design of the Medical...

Associate Director, Medical Affairs and Scientific Communications Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral...

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day....