Sr. Proposal Writer – Gmp/CMC

Sr. Proposal Writer – Gmp/CMC

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 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.

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.