Dyne Tx
Associate Director, Medical Writing
Dyne Tx - Waltham, Massachusetts, United States, 02254
Work at Dyne Tx
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Please state your consent ID and date when you contact us regarding your consent. Do not sell or share my personal information Our commitment to people with neuromuscular diseases is our greatest strength We support all people, families and caregivers living with rare diseases, this Rare Disease Day and every day Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit 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 without the possibility of being fully remote. 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 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. AT DYNE WE SUPPORT ALL PEOPLE, FAMILIES AND CAREGIVERS LIVING WITH RARE DISEASES THIS RARE DISEASE DAY AND EVERY DAY WE SUPPORT ALL PEOPLE, FAMILIES AND CAREGIVERS LIVING WITH RARE DISEASES this rare disease day and every day
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The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission.
This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
You can at any time change or withdraw your consent from the Cookie Declaration on our website.
Learn more about who we are, how you can contact us and how we process personal data in our Privacy Policy.
Please state your consent ID and date when you contact us regarding your consent. Do not sell or share my personal information Our commitment to people with neuromuscular diseases is our greatest strength We support all people, families and caregivers living with rare diseases, this Rare Disease Day and every day Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit 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 without the possibility of being fully remote. 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 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. AT DYNE WE SUPPORT ALL PEOPLE, FAMILIES AND CAREGIVERS LIVING WITH RARE DISEASES THIS RARE DISEASE DAY AND EVERY DAY WE SUPPORT ALL PEOPLE, FAMILIES AND CAREGIVERS LIVING WITH RARE DISEASES this rare disease day and every day
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