at Certara USA, LLC in Wilmington, Delaware, United States
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
informed decision-making & reduced clinical trial burden
higher R&D productivity
improved patient outcomes & increased patient access to medicines
accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Synchrogenix, a Certara Company: Achieving Regulatory Success
As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.
Synchrogenix's people are at the core of our success, and our most successful people are:
collaborative and value being part of a team
experts with a thirst for continued learning
consultative with an ability to articulate process and expertise
deadline-driven and able to operate in a fast-paced environment
The Sr. Proposal and Contract Writer (Sr. PCW) is responsible for the leading the development of complex responses to Requests for Information (RFIs), Requests for Proposals (RFPs), Statements of Work (SOWs) and Change Orders (COs). The Sr. PCW will determine proposal concept by assembling information including project scope, objectives/outcomes/deliverables, methods, timetable, staffing needs, budgets, and standards of performance and evaluation. The Sr. PCW will be responsible for the writing, revising, and editing of drafts until the final proposal is approved by management. Sr. PCWs can operate independently with minimum to no oversight on projects. This position also trains/mentors less experienced staff, and drives implementation of process and development initiatives. This role reports to the Associate Director, Commercial Operations.
Key duties and responsibilities include
* Lead daily coordination of team prioritization activities when needed
* Independently write proposals, SOWs, and COs, and develop project budgets across accounts and global opportunities under tight deadlines in support of Business Development (BD)
* Prepare responses to RFIs, RFPs, SOWs, COs, and Questionnaires with little oversight
* Prepare SOWs and COs according to client and internal specifications/standards
* Create and maintain content within a content database
* Complete desktop publishing of proposals, SOWs, and COs as required
* Perform quality control review, adjudicate comments, and edit proposals, SOWs, and COs as required
* Participate in client meeting preparations, as needed
* Support Functional Department Heads and Business Unit Leaders on the implementation of operational strategies for proposals
* Support administrative aspects of proposal development, including, but not limited to tracking proposal/SOW/CO status in the company's customer relationship management system, contributing to metrics reports, and ensure security and integrity of documentation
* Perform contract vetting, finalization, and signature procurement activities as required
* Lead team with process and development initiatives
* Mentor/train newly hired proposal/contract staff as needed
* Liaise with internal Subject Matter Experts and external partners for proposal development input
* Conduct analysis and develops tools to drive process improvements and functional excellence
Education, Experience, Training, and Knowledge
* Bachelor's degree from an accredited institution or equivalent in a science,... For full info follow application link.
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.