Associate Director, Medical Writing at Acadia Pharmaceuticals

Conshohocken, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development
Able to analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences
Ensure accuracy and consistency in the quality control of documents with precise attention to detail
Work collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexity
Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies
Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems
Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP)
Preferred
Familiarity with designing and operationalizing clinical studies
Advanced degree in scientific area
Experience in liver, cardiovascular or metabolic diseases

Responsibilities

Write documents supporting Phase 1 through IV clinical trials (primarily clinical study protocols, clinical study reports and investigators brochures)
Collaborate closely with cross-functional teams to create documents that support program goals and timelines
Ensure that documents are of the highest quality and compliant with global regulatory requirements and industry best practices (may include contributing to updates to standard operating procedures)
Contribute to the development and implementation of processes and systems to optimize Madrigal’s efficiency and productivity in document development
Stay current with regulatory guidelines, industry trends, and best practices in medical writing

Skills

Key technologies and capabilities for this role

Medical WritingClinical Study ProtocolsClinical Study ReportsInvestigator's BrochuresRegulatory ComplianceClinical Data AnalysisSOP DevelopmentPharmaceutical Drug Development

Questions & Answers

Common questions about this position

What is the compensation for the Associate Director, Medical Writing role?

Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also include additional compensation elements.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What skills and experience are required for this medical writing role?

Candidates need 6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development, ability to analyze complex clinical data, ensure accuracy and consistency with attention to detail, work collaboratively in a fast-paced environment, strong understanding of drug development processes, and experience with industry standard technical tools like templates, Microsoft Word macros, and electronic document management systems.

What is the company culture like at Madrigal Pharmaceuticals?

This information is not specified in the job description.

What makes a strong candidate for the Associate Director, Medical Writing position?

A strong candidate has 6+ years of clinical or regulatory medical writing experience, can analyze complex data and work collaboratively in a fast-paced environment, understands drug development processes, and has experience with technical tools; preferred qualifications include familiarity with clinical study design, an advanced scientific degree, and experience in liver, cardiovascular, or metabolic diseases.

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees