Apply on Employer Site

Arrowhead Pharmaceuticals · 8 hours ago

Senior Medical Writer

San Diego, California, United States

Full-time

Onsite

Mid, Senior Level

$100K/yr - $150K/yr

3+ years exp

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs that treat intractable diseases through RNA interference. The Senior Medical Writer will provide authoring support for regulatory documents, lead the creation of key supportive documents, and collaborate with cross-functional teams to ensure the quality and accuracy of clinical documentation.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Contributing author to regulatory documents such as, but not limited to, clinical study protocols and protocol amendments, investigator’s brochures (IBs), clinical study reports (CSRs), components of NDA/MAA documents, and briefing books

Lead author of numerous supporting documents such as summary of changes, patient narratives, and IB updates

Assists in planning and content creation for kick off meetings (ie, slide deck authoring)

Collaborates with nonclinical, clinical safety, biometrics, and clinical development personnel to obtain status updates and plan documents

Assists in the review of statistical analysis plans, and mock and draft statistical tables, listings and figures (TLFs)

Participates in regulatory and clinical team strategy meetings to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources

Assists in resolving team and quality control comments to ensure all comments are appropriately addressed

Assists with team training for document processes and software

Supports key pilot programs in medical writing such as new process development

Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in document management system(s)

Qualification

Medical writingRegulatory documentsClinical research knowledgeStatistical analysisMS Word proficiencyEagerness to learnCollaboration skillsFlexibility

Required

Bachelor's degree in medically-related field or life science, with a minimum of 3 years of relevant medical writing experience in the pharmaceutical industry

Master's or doctoral degree with 2 years of relevant medical writing experience in the pharmaceutical industry

Familiarity with basic statistical analysis concepts and techniques is helpful

Knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards; and demonstrated ability to interpret and apply these guidelines to document writing

A demonstrated track record of contribution to successful clinical documents such as IBs, CSRs, protocols, and protocol amendments

Prior experience in interacting with cross-functional study team members is desirable

Proficient in the use of MS Word, Excel, EndNote, Adobe Acrobat, and PowerPoint