Senior Strategic Relationship Manager

The Sr. Strategic Relationship Manager (Sr. SRM) is a regulatory development expert with a history as a regulatory writer that collaborates cross-functionally within CDDS and across Certara to provide strategic account oversight, accelerating project and contract pull through to realize revenue. The SRM provides operational and expert subject matter support to the internal Certara team as well as to clients, as required. As a client advisor, the Sr. SRM takes responsibility for bridging the gap between the client and various business units at Certara, serving as the main point of contact to manage the complex relationship and seamlessly communicate with all stakeholders. Rooted within the RSMA Practice Area, the Sr. SRM strives to expand service offerings within CDDS and the broader Certara organization. The Sr. SRM leads the partnership between the regulatory writers assigned to their client and the software team to promote use of CoAuthor.

• As a billable consultant, act as the client's main point of contact, serving as a point of escalation internally and externally, managing the complex relationship between the client, project lead, and other roles within Certara
• Assist client with short and long-term project development planning and forecasting
• Grow and expand regulatory services offerings and deliverables within existing and new client groups
• Receive new service requests from the client and obtain resourcing by working with RMO and Service Line Heads (SLHs)
• Discuss cross-sale opportunities with BD counterparts and contribute to the scoping of change orders and contracts
• Onboard and educate new project leads on client-specific processes, training and document requirements, historical expectations, and appropriate use of CoAuthor
• Support project leads with setting and meeting deadlines, monitoring budgets and project health, and program specific context/key messaging
• Liaise with Certara QA and the client during client compliance audits. In support of those audits, ensures current versions of standard operating procedures, work instructions, documentation forms, and templates for work are maintained and available to writers and other Certara personnel, as appropriate
• Participate in client projects as assigned and/or as a backup, listening to stakeholders to understand the major goals of the engagement
• Maintain collaborative, proactive, and effective communication with the client and conduct regular client meetings, reporting on required KPIs/metrics
• Conduct regular internal meetings with project leads and BD, when appropriate, to discuss the status of deliverables and ensure all are supported
• Promotes the quality of deliverables by performing (or delegating) peer reviews to ensure continuity across documents in terms of program goals, client's preferences, standards, and messaging.
• Provide coaching to junior-level staff assigned to clients.
• Other duties as required by the business.

Qualifications:

• Bachelor's degree or higher. Scientific discipline strongly preferred
• 3 to 5+ years of relevant (Regulatory and/or Medical Writing, Document Quality) experience in the drug development industry; experience at both vendors and sponsors preferred to enable translation across the company's and clients' needs
• Proficiency with Microsoft Word skills (editing tools, creating, and modifying tables, and inserting figures) and document management techniques
• Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance

Skills & Abilities:

• Clear and concise communicator, detail and process-oriented
• Able to engage cross-functionally and leverage industry experience to create efficiencies across a partnership, communicating when warning signs emerge within a project
• Experience interfacing with scientists on complex, data intensive projects with a deeply analytical set of scientific stakeholders
• Strong understanding of the document creation process and of the drug development lifecycle
• Ability to work in a collaborative environment, be tolerant of differences in culture and beliefs, easily build relationships with others, openly share information, and willingly contribute toward accomplishment of team goals
• Be action and detail oriented, always seeking new development opportunities to build knowledge and skills
• Show flexibility to meet project needs as required by deadlines and to meet corporate goals and objectives
• Remain knowledgeable of changes in the industry and adapt best practices
• Demonstrate solid time management and other organizational skills
• Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
• Ability to identify and institutionalize work practices that are most effective to ensure consistency in performance

Other Information:

Number of Employees Supervised: Not Applicable

Percentage of Travel Required: As required to support corporate and business activities, typically less than 10%

Special Requirements: None

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.