Regulatory
Senior Medical Writer
Office Location: San Diego, CA
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Medical Writer will collaborate with lead medical writers and cross-functional team members to provide authoring support to numerous regulatory documents. The Senior Medical Writer will also lead key supportive documents. The Senior Medical Writer will author with accuracy and technical competency to ensure delivery of high quality regulatory clinical documents in a timely manner. The Senior Medical Writer will demonstrate a high level of flexibility, collaboration skills, and eagerness to learn.
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).
Requirements:
- 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
Preferred:
- Exemplary time management and self-management skills
- Good communication and people skills
- Resilience and flexibility under pressure
- Knowledge of International Council for Harmonisation (ICH) and other relevant regulatory guidelines
- Excellent technical skills, including table creation and formatting. If lacking these skills, willing to learn and master the skill set.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.