H-1BEmpresa con historial de patrocinio ante el gobierno
REG. 410494
Director, Cumplimiento Normativo
Dyne Therapeutics, Inc.
- Lugar: Waltham, MA
- Área: Jurídico
- Visa probable: H-1B
- Empleo visto por última vez el 14/7/2026
Puesto de dirección en cumplimiento normativo en una biofarmacéutica de Waltham, MA.
Cuenta gratis — el contacto y el enlace oficial del empleo están en el portal.
Descripción del empleo (original, en inglés)
<div class="content-intro"><h3>Company Overview:</h3>
<p>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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at <a href="[enlace en el portal] and follow us on <a href="[enlace en el portal] <a href="[enlace en el portal] <a href="[enlace en el portal] Summary:</strong></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">The Director of Compliance provides compliance guidance on a wide range of commercialization issues as Dyne scales and prepares for the anticipated launch of its first therapies. These topics include HCP and patient engagement, disease‑state education, compliance with FDA regulations, health care fraud and abuse laws, Value & Access matters, patient support programs, data privacy, and various federal and state laws governing the pharmaceutical industry.</span><span data-ccp-props="{"201341983":0,"335559740":276}"> </span></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">The Director of Compliance helps design and implement a global compliance program to ensure that Dyne complies with all applicable laws, regulations, and ethical codes where the company operates. The Director of Compliance works closely with Medical, Commercial, Regulatory Affairs, and G&A colleagues. We seek a strategic, collaborative, solutions‑oriented leader with deep knowledge and experience. Prior rare‑disease and launch experience enables the Director of Compliance to help Dyne navigate the challenges of our first therapy launches.</span><span data-ccp-props="{"201341983":0,"335559740":276}"> </span></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">This role is based in Waltham, MA, without the possibility of being a remote role. </span><span data-ccp-props="{"201341983":0,"335559740":276}"> </span></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"> <br><strong><span data-contrast="none">Primary Responsibilities Include:</span></strong><span data-ccp-props="{"201341983":0,"335559740":276}"> </span></p>
<ul>
<li><span data-contrast="none"><span data-ccp-parastyle="Body" data-ccp-parastyle-defn="{"ObjectId":"b669530d-9cee-5fd4-8da3-4cdbed7bfaa2|1","ClassId":1073872969,"Properties":[469775450,"Body",201340122,"2",134233614,"true",469778129,"Body",335572020,"1",469777841,"Helvetica",469777842,"Helvetica",469777843,"Helvetica",469777844,"Helvetica",469769226,"Helvetica",335551500,"0",268442635,"22"]}">Design and implement a comprehensive health care compliance program consistent with all laws, regulations, </span><span data-ccp-parastyle="Body">policies</span><span data-ccp-parastyle="Body"> and industry standards.</span></span><span data-ccp-props="{"201341983":0,"335559740":276}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Establish and refresh corporate policies, </span><span data-ccp-parastyle="Body">procedures</span><span data-ccp-parastyle="Body"> and guidelines to ensure compliant operations across all Commercial, Medical and </span><span data-ccp-parastyle="Body">research</span><span data-ccp-parastyle="Body"> activities.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead risk assessments to </span><span data-ccp-parastyle="Body">identify</span><span data-ccp-parastyle="Body"> and prioritize compliance risks</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Develop and deliver risk-based compliance training for employee</span><span data-ccp-parastyle="Body">s.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Develop and implement auditing & monitoring plans and related dashboards</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead confidential, thorough investigations into potential violations</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Establish Compliance as an approachable, knowledgeable, practical, helpful, solutions-oriented business partner</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Collaborate closely with the Franchise Counsel to </span><span data-ccp-parastyle="Body">align on</span><span data-ccp-parastyle="Body"> consistent, actionable legal and compliance solution</span><span data-ccp-parastyle="Body">s.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Champion Dyne’s core values and culture of integrity</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Perform </span><span data-ccp-parastyle="Body">additional</span><span data-ccp-parastyle="Body"> duties as </span><span data-ccp-parastyle="Body">required</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></li>
</ul>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Experience a</span><span data-ccp-parastyle="Body">nd Skills Requirements:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p>
<ul>
<li><span data-contrast="auto">Advanced degree in law, business administration or related field.</span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="auto">10+ years of overall professional experience, including at least 7+ years of healthcare compliance experience, ideally within a global rare disease biotechnology company.</span><span data-ccp-props="{}"> </span></li>
<li><span data-contrast="auto">Deep expertise in U.S. health care laws, federal health care programs, and therapy launches.</span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="auto">Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws.</span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="auto">Experience supporting compliant patient engagement, HCP engagement, scientific exchange, and innovative patient support programs.</span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="auto">Proven success advising cross-functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&A) on complex, time-sensitive matters.</span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li
Cuenta gratis — el contacto y el enlace oficial del empleo están en el portal.