Associate, Global Scientific Communications Regulatory Medical Writing

Chester, Maryland, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree in a scientific, health, communications, or technology health-related field. Legal authorization to be employed in the United States is required, with no sponsorship anticipated. Demonstrated experience in technical/regulatory scientific writing and mastery of verbal and written English in medical, scientific, or technical writing fields are essential. Additional preferences include clinical pharmacology, therapeutic area knowledge, strong communication and interpersonal skills, and successful completion of a writing exercise.

Responsibilities

The Associate, Global Scientific Communications Regulatory Medical Writer will lead the development of regulatory documents, including protocols, clinical study reports, and marketing authorization applications. Responsibilities include creating content strategies, writing, editing, and coordinating document finalization, building scientific rationale, managing expert reviews, and influencing timelines and content. The role also involves leading the writing process with effective project management, building credible writing timelines, mitigating risks, and aligning with teams for smooth document development. Maintaining and enhancing knowledge of regulatory and publication guidelines, understanding therapeutic areas, and sharing best practices are also key duties.

Skills

Regulatory Medical Writing

Protocol Development

Clinical Study Reports

Briefing Documents

Regulatory Responses

Investigational New Drug Applications

Marketing Authorization Applications

Content Strategy

Scientific Writing

Editing

Document Management

Cross-functional Team Collaboration

Presentation Development

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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