Arrowhead Pharmaceuticals, Inc
Associate Director, Medical Writing
Arrowhead Pharmaceuticals, Inc, Pasadena, California, United States, 91122
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 Associate Director, Regulatory/Medical Writing collaborates with members of cross‑functional teams to prepare high-quality regulatory and clinical documentation for submission to global regulatory agencies including the preparation of components for INDs/NDAs, annual reports, Orphan Drug Designation applications, and briefing books as well as clinical study documentation such as protocols, investigator brochures, etc as required within agreed-upon timelines. The Associate Director also assists with the preparation of publications, abstracts, and other external communications in support of Arrowhead business functions. The Associate Director also assists in implementing processes and standards to ensure company scientific documents are prepared to the highest editorial standards and quality.Responsibilities
Prepares, edits, and finalizes protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, briefing books, etc)Prepares related clinical documents, such as abstracts, posters, presentations, and manuscriptsCollaborates with and manages contract medical writers as required for project assignmentsAdvises and assists in the review and management of nonclinical and CMC technical reports as requiredDevelops and maintains company house-standard templates and best review practices for regulatory and clinical documentation. Ensure vendors and contractors maintain company standardsParticipates in regulatory and clinical team strategy meetings to ensure that results and messages in clinical documents accurately reflect the data in tables, figures, and listings (TFLs) and other information sources Partners with the scientific staff including participation in the review of mock and/or blinded TFLs, and narrative planning for relevant documentsAssists in the development and maintenance of Development Core Product Data Sheets, draft labeling, and company work instructions and SOPs, as requestedEnsures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines and medical editorial boardsManages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. Schedules and conducts document-related meetings including kickoff meetings and document review planning and alignment discussions to ensure documentation timelines are achievedEnsures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in appropriate document management system(s)Ensures that appropriate documented quality control (QC) checks are performed on regulatory/medical writing deliverables, responds to findings, and recommends quality process improvementsRequirements:
Bachelor’s degree in medically related field or life science6 to 8 years of relevant medical writing experience in the pharmaceutical industry is essentialMust have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. Familiarity with basic statistical analysis concepts and techniques is requiredA demonstrated track record of contribution to successful regulatory components used in filings eg, IND/CTAs, NDA/BLA/MAAs is importantPrior experience in interacting with cross-functional study team members is essentialHighly proficient in the use of MS Word, Excel, Endnote, Adobe Acrobat, PowerPoint, and structured document templatesPreferred:
Post-graduate degree (master’s or doctoral)Experience with electronic document management systemsExperience writing in one or more of the company’s key therapeutic areas eg, liver disease, respiratory disease, or rare diseasesMembership in professional medical writing, regulatory, or drug information associationsSalary: $160,000 — $185,000 USDArrowhead provides competitive salaries and an excellent benefit package.All applicants must have authorization to work in the US for a company.
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The Associate Director, Regulatory/Medical Writing collaborates with members of cross‑functional teams to prepare high-quality regulatory and clinical documentation for submission to global regulatory agencies including the preparation of components for INDs/NDAs, annual reports, Orphan Drug Designation applications, and briefing books as well as clinical study documentation such as protocols, investigator brochures, etc as required within agreed-upon timelines. The Associate Director also assists with the preparation of publications, abstracts, and other external communications in support of Arrowhead business functions. The Associate Director also assists in implementing processes and standards to ensure company scientific documents are prepared to the highest editorial standards and quality.Responsibilities
Prepares, edits, and finalizes protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, briefing books, etc)Prepares related clinical documents, such as abstracts, posters, presentations, and manuscriptsCollaborates with and manages contract medical writers as required for project assignmentsAdvises and assists in the review and management of nonclinical and CMC technical reports as requiredDevelops and maintains company house-standard templates and best review practices for regulatory and clinical documentation. Ensure vendors and contractors maintain company standardsParticipates in regulatory and clinical team strategy meetings to ensure that results and messages in clinical documents accurately reflect the data in tables, figures, and listings (TFLs) and other information sources Partners with the scientific staff including participation in the review of mock and/or blinded TFLs, and narrative planning for relevant documentsAssists in the development and maintenance of Development Core Product Data Sheets, draft labeling, and company work instructions and SOPs, as requestedEnsures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines and medical editorial boardsManages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. Schedules and conducts document-related meetings including kickoff meetings and document review planning and alignment discussions to ensure documentation timelines are achievedEnsures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in appropriate document management system(s)Ensures that appropriate documented quality control (QC) checks are performed on regulatory/medical writing deliverables, responds to findings, and recommends quality process improvementsRequirements:
Bachelor’s degree in medically related field or life science6 to 8 years of relevant medical writing experience in the pharmaceutical industry is essentialMust have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. Familiarity with basic statistical analysis concepts and techniques is requiredA demonstrated track record of contribution to successful regulatory components used in filings eg, IND/CTAs, NDA/BLA/MAAs is importantPrior experience in interacting with cross-functional study team members is essentialHighly proficient in the use of MS Word, Excel, Endnote, Adobe Acrobat, PowerPoint, and structured document templatesPreferred:
Post-graduate degree (master’s or doctoral)Experience with electronic document management systemsExperience writing in one or more of the company’s key therapeutic areas eg, liver disease, respiratory disease, or rare diseasesMembership in professional medical writing, regulatory, or drug information associationsSalary: $160,000 — $185,000 USDArrowhead provides competitive salaries and an excellent benefit package.All applicants must have authorization to work in the US for a company.
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