Lead, Regulatory Medical Writing

Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: January 20, 2023

Job Description:

With recent approvals in the US and Canada Amylyx Pharmaceuticals is launching a new drug for the treatment of adults with ALS.
If you are looking for a place where your work can have a deeper impact than you ever imagined and where you can be true to yourself - Amylyx is the place for you!
At Amylyx, we're bringing together talented people like you who are committed to solving for humanity's most devastating diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and others-all in a uniquely supportive, respectful environment that rewards innovative thinking, committed teamwork, and boundless curiosity.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences-in all the best ways.
We provide a competitive employee benefits package including stock options and RSUs; flexible work options including hybrid and remote; discretionary time-off; comprehensive healthcare, including dental and vision coverage; and retirement savings benefits.The Opportunity
POSITION SUMMARY
We are seeking a Lead, Regulatory Medical Writing who will work collaboratively cross-functionally to produce documents to support Amylyx development programs in neurology. This role requires a strategic thinker with a variety of experience in clinical development with deep insight into how different functions contribute to the success of the company.
RESPONSIBILITIES

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• Work with internal and external subject experts to plan, prepare, edit, and finalize protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, meeting briefing books, etc.).
  
• Manage the internal review process, including internal and external technical review, while driving sign-off timelines.
  
• Collate materials, both internal and external, and ensure that documents using these materials accurately and concisely reflect appropriate sources of information.
  
• Manage Amylyx-standard templates, in accordance with ICH and regulatory guidelines. Implement appropriate document QC procedures in accordance with Amylyx Quality Guidelines.
  
• Manage vendors and contractors for production of documents when necessary.
  
  REQUIREMENTS
  
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  • Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.
    
  • Must have at least 10 years in technical/scientific writing with 5 years of experience in managing scientific documents (e.g., nonclinical, clinical, regulatory, etc.) including publishing and submissions.
    
  • Strong knowledge of FDA/ICH guidelines and GCP.
    
  • Provide leadership and management for complex documentation projects
    
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
    
  • Experience in coordination and prioritization of multiple projects in a fast-paced environment.
    
  • Must have proven ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users.
    
  • Fluent in English (oral and written communication) skills.
    
  • Awareness of pharmaceutical industry needs beyond clinical development and medical affairs.
    
    
    COVID-19 Vaccination Policy: Candidates should be aware that Amylyx's current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.
    
    To return to our website please .
    Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Keywords: Amylyx Pharmaceuticals, Cambridge , Lead, Regulatory Medical Writing, Other , Cambridge, Massachusetts