Senior Proposal Writer - GMP/CMC

March 21

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

✏️ Content Writer

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BioAgilytix

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BioAgilytix is a leading provider of bioanalytical services trusted by biopharmaceutical companies to deliver quality data and expertise at every stage of drug development. With over 30 years of experience, BioAgilytix specializes in demanding areas of bioanalysis, such as method transfer, assay creation, sample analysis, and commercial diagnostic testing. The company collaborates closely with clients to ensure precise, on-time results that withstand regulatory scrutiny, aiding in the creation of therapies that transform patient care. BioAgilytix is highly recognized for its scientific expertise, regulatory excellence, and consultative approach, serving clients across the globe.

Immunoassays • Cell-Based Assays • Immunogenicity • Pharmacokinetics • Biomarkers

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• At BioAgilytix, we are passionate about premier science and the impact it has on our world. • Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. • We are tirelessly committed to our customers by being solution-oriented and deadline-driven. • The Senior Proposal Writer independently performs all aspects of quote and proposal development, with a specific focus on CMC Analytical services. • This role will provide direct support to the Manager, Proposal Services, and Associate Director, Proposal Services, assisting with the determination of pricing and scope across all bioanalytical projects. • While this is not a lab-based role, the ideal candidates will have regulated scientific laboratory and writing experience.

🎯 Requirements

• 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. • 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.

🏖️ 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