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Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. Company Overview

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary

The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position is responsible for the medical writing activities for one or more clinical programs and will interact with other functions (eg, clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs) as necessary. This position will function with limited supervision as required and ensures deliverables are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.

Previous experience in authoring and reviewing clinical, nonclinical, and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical. Outstanding communication skills are a must.

This role is based in Waltham, MA with hybrid work flexibility.

Primary Responsibilities Include

Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards Oversees document review comment resolution meetings Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement

Education And Skills Requirements

Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs) Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva) Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines Aptitude for compilation, analysis, and presentation of data Ability to work with multiple contributors to produce a final unified document Commitment to accuracy and detail-oriented work

The pay range displayed below is the range of base pay compensation within which the company expects to pay for this role at the time of this posting. Individual compensation depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

Salary Range

$194,000 - $213,000 USD

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.Seniority level Seniority levelMid-Senior level Employment type Employment typeFull-time Job function Job functionHealth Care Provider IndustriesInternet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Associate Medical Director jobs in Waltham, MA . Associate Medical Director/Medical Director Clinical Science - REMOTEAssociate Medical Director of Clinical Development Waltham, MA $194,000.00-$213,000.00 2 months ago Boston, MA $105,000.00-$134,000.00 1 day ago Marlborough, MA $180,400.00-$225,500.00 3 days ago Associate Director/Principal Medical Writer Cambridge, MA $147,000.00-$212,333.33 1 week ago Associate Medical Director (FULL TIME OR PART TIME) Boston, MA $85,710.00-$171,420.00 4 weeks ago Bedford, MA $144,000.00-$216,000.00 4 days ago Boston, MA $265,000.00-$285,000.00 4 weeks ago Associate Clinical Development Medical Director Cambridge, MA $204,600.00-$379,400.00 1 week ago Associate Director, Audit Management - Medical Device (Remote) Waltham, MA $179,200.00-$224,000.00 2 days ago Associate Director, Medical Affairs, Operations Boston, MA $168,000.00-$212,400.00 1 day ago Watertown, MA $300,000.00-$400,000.00 1 week ago Associate Medical Director, Pharmacovigilance and Risk Management (PVRM) Marlborough, MA $180,400.00-$225,500.00 6 days ago Associate Medical Director, Clinical Development Boston, MA $265,000.00-$285,000.00 2 weeks ago Associate Director, Medical Strategic OperationsAssociate Director, Medical Strategic OperationsMedical Affairs Associate Director - Cystic Fibrosis Boston, MA $208,100.00-$312,200.00 6 days ago Associate Medical Director, Drug Safety Physician *PC 1483 Waltham, MA $222,500.00-$261,700.00 2 weeks ago Medical Affairs Strategy Associate Medical Director - Pain (Boston) Boston, MA $231,900.00-$347,800.00 2 weeks ago Associate Director/Director, Medical & Regulatory Writing Boston, MA $175,183.00-$204,532.00 6 days ago Medical Affairs Science Associate Director, Povetacicept Programs Boston, MA $156,000.00-$234,000.00 2 weeks ago Associate Director, Quality - GMP/ Med DeviceAssociate Director, US Health Economics and Outcomes Research & Real-World Evidence Cambridge, MA $143,250.00-$210,100.00 1 week ago Waltham, MA $215,000.00-$246,000.00 2 months ago RN Program Manager Lowell General and MelroseWakefield Hospital We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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