Sr. Proposal Writer - GMP/CMC Job at US Company in Boston
US Company - Boston, MA, United States, 02298
Work at US Company
Overview
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Overview
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. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
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. We are seeking candidates with experience in a corporate GMP and GxP setting. While this is not a lab-based role, the ideal candidates will have regulated scientific laboratory and writing experience.
As a Sr. Proposal Writer your day-to-day activities will include:- Independently manages 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.
- Writes, edits, and finalizes proposals with specific focus on high priority and unique requests.
- Serves 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.
- Generates new templates to support the proposal development infrastructure.
- Works with senior Proposal Office members to implement pricing and process changes uniformly across all proposals.
- Challenges SME scopes and input based on internal guidelines.
- Maintains appropriate current knowledge of the scientific and regulatory environments.
- Understands pricing models and their application to unique scopes and client-specific requirements.
- Promotes internal expertise through training and guidance to less experienced staff on interpretation of RFP / RFI / quote requests.
- Proactively recommends improvements for proposal development best practices and processes.
- Leads SME calls and interactions.
- 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.
- 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.
- This is a full-time remote position
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Occasional weekend, holiday, and evening work required
- Occasional travel required
BENEFITS AND OTHER PERKS
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
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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