Axsome Therapeutics Inc

Associate Principal Writer, CMC Technical Writing

Wyoming, Michigan, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
BiopharmaceuticalIndustries

About PTC Therapeutics

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Job Description Summary

The Associate Principal Writer for CMC Technical Writing at PTC Therapeutics (PTC) provides CMC technical knowledge and expertise for Chemistry, Manufacturing, and Control (CMC) regulatory document submissions to global health authorities. Responsibilities include authoring, editing, content verification, and providing input to CMC-related documents required for regulatory submissions. The incumbent will collaborate closely with Regulatory CMC Leads, as well as cross-functionally with PTC internal departments and external partners, on CMC technical writing related issues. Additionally, the Associate Principal Writer of CMC Technical Writing will contribute to the development of CMC-related documents in accordance with all applicable regulations including current Good Manufacturing Practices (cGMPs), applicable regulatory guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association [EMA] Clinical Trials Directives, International Congress on Harmonisation [ICH] guidelines), and company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.

Responsibilities

  • Leads analysis and interpretation of CMC-related technical data (from SOPs, Batch Records, Reports, etc.) to author CMC dossier content for clinical trial applications (e.g., IND/IMPDs), marketing applications (e.g., NDA/BLA/MAAs), and other documents needed to support regulatory interactions and health authority filings for small molecules and/or biologics.
  • Performs editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
  • Coordinates authoring and review activities with Regulatory CMC leads, Pharmaceutical Development/Technical Operations, and Quality Assurance Teams to reach regulatory alignment and to meet deadlines for health authority submissions.
  • Participates in key cross-functional meetings to align on general strategy for content and authoring of documents.
  • Works closely with Global Regulatory Affairs (GRA) to establish priorities and ensure successful completion of CMC-related authoring activities, including timely handover of intended submission content to the Regulatory Operations Team.
  • Ensures key persuasive messaging is clear and consistent within and across documents.
  • Ensures consistent document presentation style to maintain quality, ease of review, and adherence to company standards.
  • Exhibits required attention to detail, including fact checking, logic flow, parallelism, formatting, and document structure.
  • Contributes to the development and standardization of templates and submission related processes.
  • As needed, assists in day-to-day operational activities and other assignments specified by management.

Qualifications

  • Education: Advanced degree (PhD, PharmD, or MS) with 5+ years in pharma/biotech industry with at least 3 years for regulatory CMC writing experience in pharmaceutical industry OR Bachelor’s degree in a scientific discipline with 7+ years of experience in a pharmaceutical, biotechnology, or CROs.
  • Experience: Demonstrated experience in a CMC writing role, including participation in investigational, initial and/or post-approval submissions to the US FDA (IND, NDA, BLA) and/or EMA (IMPD, MAA).
  • Knowledge: Broad knowledge of ICH, EMA, and FDA guidance beyond those pertaining to specific regulatory documents.
  • Skills: Excellent attention to detail, including fact checking, logic flow, parallelism, formatting, and document structure.

Skills

CMC Technical Writing
Regulatory Submissions
IND
IMPDs
NDA
BLA
MAAs
cGMP
ICH guidelines
SOPs
Technical Data Analysis
Editing
Content Verification

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters
2012Year Founded
$430.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees

Benefits

Performance Bonus
Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.
Potential delays in AXS-07 launch amid growing market anticipation.
Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.
AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.
Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.
Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.
Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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