Senior Proposal Writer - GMP/CMC

Summary

Join BioAgilytix as a Senior Proposal Writer and contribute to groundbreaking scientific advancements. This remote, full-time position focuses on developing proposals and quotes for CMC Analytical services. You will collaborate with various departments, write and edit proposals, and ensure timely delivery to clients. The ideal candidate possesses extensive experience in proposal writing within a GMP/GxP context, strong scientific knowledge, and excellent communication skills. BioAgilytix offers a fast-paced, fun work environment with opportunities for career development and a comprehensive benefits package.

Requirements

• Proven experience in proposal writing, specifically within CMC/GMP context
• Strong knowledge of the CMC landscape, GMP, and GxP regulations
• Excellent oral and written communication skills and ability to successfully interact with key internal stakeholders and clients under time constraints
• Knowledge of the principles, terminology, and methodology of proposal preparation
• High level of proficiency in Microsoft Office (Word, Excel, SharePoint)
• Superior attention to detail and strong organizational skills
• Ability to coordinate multiple projects/tasks while still delivering high quality results in a timely manner
• Ability to work closely within a trusted team environment where sharing and teamwork are valued
• Critical thinker that can identify and understand issues, problems, and opportunities from disparate sets of information and provide clear conclusions and guidance
• Ability to quickly assess and prioritize competing demands
• Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or a related field
• At least three (3) years of experience in a regulated GMP/GxP scientific environment, including a combination of direct laboratory or support experience
• A minimum of seven (7) years of experience in proposal writing and development, technical writing/editing, and collaborating with subject matter experts in biotech, pharmaceutical, CRO/CMO, or similar organizations, or in combination with other relevant experience
• High level of proficiency with Salesforce.com or similar CRM platforms

Responsibilities

• Independently manage the development of proposals and quotes for CMC Analytical services and other bioanalytical groups
• Collaborate with departments such as Business Development, Scientific Office, Operations, Finance, and others to compile proposals, and ensuring timely delivery of assigned proposals to clients
• Write, edit, and finalize proposals with specific focus on high priority and unique requests
• Serve as a liaison between operations and commercial to effectively plan and support content related to their objectives and follows up with team members for feedback and revisions
• Generate new templates to support the proposal development infrastructure
• Work with senior Proposal Office members to implement pricing and process changes uniformly across all proposals
• Challenge SME scopes and input based on internal guidelines
• Maintain appropriate current knowledge of the scientific and regulatory environments
• Understand pricing models and their application to unique scopes and client-specific requirements
• Promote internal expertise through training and guidance to less experienced staff on interpretation of RFP / RFI / quote requests
• Proactively recommend improvements for proposal development best practices and processes
• Lead SME calls and interactions

Preferred Qualifications

• Master's degree or Ph.D. in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than seven (7) years' experience in a regulated GxP scientific laboratory environment
• Demonstrated leadership and coaching ability

Benefits

• Medical Insurance (HDHP with HSA; PPO)
• Dental Insurance
• Vision Insurance
• Flexible Spending Account (medical; dependent care)
• Short Term Disability
• Long Term Disability
• Life Insurance
• Paid Time Off (4 weeks per year)
• Parental Leave
• Paid Holidays (9 scheduled; 5 floating)
• 401k with Employer Match
• Employee Referral Program