Associate Principal Writer, CMC Technical Writing

Wyoming, Michigan, United States

Apply with AI Apply

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Candidates should possess an advanced degree (PhD, PharmD, or MS) with over 5 years in the pharma/biotech industry, including at least 3 years of regulatory CMC writing experience, or a Bachelor's degree in a scientific discipline with 7+ years of experience in pharma, biotech, or CROs. 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), is required. A broad knowledge of ICH, EMA, and FDA guidance beyond specific regulatory documents is necessary, along with excellent attention to detail, fact-checking, logic flow, and formatting skills.

Responsibilities

The Associate Principal Writer for CMC Technical Writing will provide CMC technical knowledge and expertise for regulatory document submissions to global health authorities. Responsibilities include authoring, editing, content verification, and providing input to CMC-related documents for regulatory submissions. The role involves collaborating with Regulatory CMC Leads, cross-functional teams, and external partners on CMC technical writing issues. The incumbent will lead the analysis and interpretation of CMC-related technical data to author CMC dossier content for various applications and documents, perform editorial reviews of documents, and coordinate authoring and review activities to meet submission deadlines. They will also participate in cross-functional meetings, align with Global Regulatory Affairs on priorities, ensure key persuasive messaging is clear and consistent, maintain consistent document presentation style, and contribute to the development and standardization of templates and processes.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free