Responsible for activities related to Medical Writing/Editing/Compiling, QC checks on the data in reports to ensure the timely preparation and submission of critical clinical and regulatory documents such as IND/CTA, BLA/MAA, briefing documents, DSURs, clinical protocols, clinical study reports, and investigator brochures for pharmaceutical products (commercial and/or pipeline).
He/she will also support the writing and preparation of clinical study summaries and other scientific and regulatory communications, as needed, for Aimmune Nestle Health Science products.
Specific Responsibilities:
• Contribute to key clinical and regulatory document content development and critically assess, interpret, and summarize data from clinical studies to produce high‑quality communications.
• Responsible for regulatory documents such as IND/CTA, BLA/MAA, briefing documents, DSURs, clinical protocols, clinical study reports, and investigator brochures for pharmaceutical products (commercial and/or pipeline).
• Develop standards, templates, procedures, and optimized processes for key clinical and regulatory document development.
• Collaborate with the team leader and team members to develop and manage timelines for regulatory submissions and scientific communications for the company.
• Build and maintain an effective team by recruiting and hiring appropriate personnel to execute tasks related to clinical and regulatory document development preparation and completion of reports within the established time frame.
• Oversee personnel to organize, manage, and execute tasks related to the development of documents, ensuring that timelines are met and that documents are completed per company standards and processes.
• Ensure consistency in documents within and across programs by managing messages and developing and maintaining document standards, models, and templates.
• Develop appropriate SOPs and work instructions for each functional area within the medical writing and science communications group.
• Identify continuous improvement opportunities and act to improve processes.
Qualifications / Requirements:
• BS/BA in a relevant discipline; an advanced degree is preferred.
• At least 10 years of experience within the pharmaceutical industry.
• 5+ years of specific leadership and management experience
• Advanced knowledge of researching, writing, editing, and reviewing clinical documents.
• Management of a team of medical writing and scientific professionals.
• A solid understanding of clinical data analysis, reporting, and presentation.
• Ability to integrate, interpret, and summarize scientific data from a variety of primary sources in a clear and concise manner.
• Expert in AMA style, medical terminology, and appropriate referencing procedures.
• Excel in teamwork, organization, and project management.
• Able to interact directly and effectively with internal clients and experts across R&D functions, commercial functions, and business partners.
• Outstanding attention to detail and exceptional judgment and follow-through with assigned tasks.
• In‑depth experience with electronic submissions and document templates.
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption.
Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies.
In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions