Scientific Writer (Pharmaceutical Drug Development) - Contractor

Our drug discovery and early clinical development team is a cross-functional group of scientists and development experts. Indications are therapeutically agonistic but have a strong focus on oncology and inflammation/immunology. The group applies our proprietary physics-based drug design and optimization platform to the drug discovery process, which has successfully advanced ten programs into preclinical development, four programs into clinical development, and one to an FDA approval.  

Who will love this job:

• A seasoned scientific writer with diverse expertise across nonclinical and clinical to ensure high-quality document deliverables.
• A self-starter who has the knowledge, experience and know-how to build out best practice document quality, formatting, and control capabilities for a growing organization.
• A self motivator with flexibility and adaptability to change
• The key to success in this role is collaboration, the ability to do research, produce well-written reports with proper documentation, and meet assigned deadlines under the supervision of the Executive Director of Biology.

What you will do:

• Support discovery and regulatory team members for the preparation of discovery pharmacology, drug metabolism and pharmacokinetics, and toxicology reports and summaries in preparation for regulatory submissions
• Review, edit, and finalize nonclinical study reports from contract research organizations (CROs) for module 4 IND submission
• Draft, edit, and finalize summary reports for select sections of module 2 IND for regulatory submission, including quality overall summary, non-clinical and clinical overviews, non-clinical summaries (tabulated and written)
• independently draft and manage reviews of documents across various therapeutic target areas
• Independently author submission-ready pharmacology and DMPK reports across various therapeutic target areas based on contract research organization study reports.
• Manage timelines, deliverables, arrange cross functional meetings, lead cross-functional meetings, drive resolution and gain alignment
• Provide editorial support, with a focus on clarity, accuracy, and consistency while maintaining adherence to proper format and regulatory requirements 
• Adhere to a report process flow and alert appropriate personnel if a process change or delay occurs
• Initiate and manage multiple rounds of document review and ensuing revisions for regulatory submissions by proactively interacting with all levels of reviewers from subject matter experts to senior management
• Take direction well and assume responsibility for the completion of the assigned work

What you should have:

• Previous experience with multiple IND applications, both preparation and submission
• Strong attention to detail, establishing priorities, scheduling and time management
• Demonstrated ability to work effectively in a flexible environment
• Ability to work independently, take initiative, and complete tasks to meet deadlines
• This role requires a BS/MS in a Scientific field and 2 or more years proven experience in the biopharma industry
• The ideal candidate must be proficient in preparing accurate, written reports and have the demonstrated ability to establish priorities and adhere to timelines
• Computer proficiency (Word, Excel, Adobe, and related software) and fluency in the English language is required
• Knowledge of drug discovery, preclinical and clinical development and ICH/GCP principles
• Strong PC skills: Google Suite and Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)
• Experience with BOX, Google Drive, and Asana is an added bonus