Overview:
Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.
The Manager, Contracts & Proposals (MCP) is responsible for writing and delivering contracts, proposals, statements of work (SOW), and other scientific documents developed according to project specifications. The MCP will work effectively and closely with the Senior Director, Commercial Operations, Certara Drug Development Solutions (CDDS) project leads (PL) and other key content owners to establish fundamental messages for the documents. The MCP will apply scientific writing, editing, document and project management expertise, and contribute to the functional excellence of documentation through process management and strategic partnership.
Responsibilities:
- Based on outlines of project specifications provided by PL, the MCP develops appropriate SOW’s and proposals suitable for subsequent refinement by the PL
- Writes scientific content for a variety of projects according to client specifications
- Puts proposals into legal, executable formats according to Certara’s business standards
- Enters and updates (as appropriate) SOW opportunities in Certara’s customer relationship management (CRM) system
- References materials according to internal SOPs and client specifications
- Works with the leadership and team members/PL to ensure that content follows client specifications, is instructionally sound, scientifically valid, well organized, and grammatically correct
- Researches scientific, medical, and client material to ensure content accuracy and relevance
- Works with all team members and departments to produce a uniform product
- Prepares (writes or substantively edits) regulatory documents in accordance with applicable regulatory guidelines/client standards/SOPs, ensuring high scientific quality and consistency with other documents where appropriate
- Liaises with document contributors to gather information (including Licensing partners where relevant)
- Plans and creates timelines for the production of assigned documents. Ensures planning and requests resources for all documents, including work to be outsourced.
- Resolves issues, errors, or inconsistencies in data with contributors as appropriate
- Reviews documents for: organization/clarity/grammar/scientific standards/internal consistency (e.g., between text and data displays).
- Manages the review process, including leading/coordinating adjudication of review comments and incorporating client review comments
- Ensures that SOW pricing adheres to Certara’s current business standards
- Performs quality control (QC) review of documents prepared by CDDS consultants
- Participates as a member of key functional/cross functional team(s), ensuring that teams adequately plan for document deliverables
- Actively contributes to best practices and continuous improvement
- Keeps informed on regulatory, scientific and medical issues important to drug development, assigned products, and disease/therapeutic areas
Qualifications:
- Post-secondary degree in related scientific field (e.g., pharmaceuticals, biomedical field)
- Demonstrated clear, high-quality scientific writing style in the English language
- Minimum of 3 years’ experience in scientific proposal writing
- Strong communication and interpersonal skills
- Excellent computer skills: Microsoft Office
- Comfortable working in a fast-paced, collaborative environment
- Good interpersonal and verbal communication skills
- Member of a writing association
- Project management skills: consistently achieves multiple tasks and goals on-time
- Experience of writing clinical and/or safety documents (e.g., IB, CSR, Module 2 documents, DSUR, PBRER, RMPs, etc.) preferred but not essential
- Experience in regulatory affairs or related functions in drug development preferred but not essential
- Experience in grant proposals or related functions preferred but not essential
Skills & Abilities:
- Knowledge or formal training in medical or scientific writing
- Prior experience in medical writing
- Understanding of Instructional Design principles
- Knowledge of AMA style guide
- Knowledge of the pharmaceutical industry
- Experience in multimedia writing
Percentage of Travel Required: As required to support corporate and business activities, typically less than 10%
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
