Manager, CMC/ Nonclinical Writing

Job Description

• Maintains a strong understanding of regulations and guidance as they pertain to CMC and/or nonclinical writing; mentors others; advises on MMS updates related to regulatory updates
• Understands styles of writing for various document types, including more complex document types and mentors others; is the document subject matter expert (SME)
  • Experience with CMC and/or Nonclinical documents required
• Proficient with Medical Writing (MW) tools, training, and processes; provides mentorship to others; is the SME
• Proficient in understanding impact of updates in related deliverables and mentors others
• Proficient with managing client meetings and CRMs and provides mentorship to others
• Proficient with managing a project from start to finish and provides mentorship to others
• Proficient with identifying and mitigating project risk and provides mentorship to others
• Proficient with understanding client gaps as opportunities, and appropriate follow up and mentors others
• Proficient with handling client feedback with appropriate feedback and provides mentorship to others
• Provide training, feedback, direction and ensure quality of deliverable
• Suggest and implement process improvements
• Responsible for planning and resourcing for on-time delivery of project deliverables that meet quality objectives
• Interact with clients on matters relating to contractual requirements, deliverable changes, timelines, and document content
• Demonstrate strong understanding of ICH guidelines, as applicable to medical writing
• Create medical training exercises, train new medical writers, and serve as a mentor
• Interact directly and independently with clients to coordinate all facets of projects; competent communicator
• Lead projects, including complex projects with multiple team members and independent coordination with client
• Demonstrate excellent internal and external leadership skills for projects
Core Competencies:
• Independently able to plan and measure activities of the direct reports. Typically requires guidance from higher level Manager to course correct colleagues performance issues and address personnel related concerns.
• Responsible for team achievement of Service Level KPIs within the area of responsibility.
• Builds strong relationship with senior level contributors and managers on the external and internal customer side. Through frequent interaction with the customers, proactively anticipates and identifies, and addresses issues with impact beyond own team based on knowledge of related disciplines. Provides guidance and coaching to the individual contributor level colleagues on how to effectively resolve clients issues and concerns, while maintaining a high degree of customer service.
• Provides direct supervision typically to team of professional individual contributors or skilled technical employees. Functions as advisor to unit and administration. Analyzes and resolves problems, interprets policies (e.g., HR, contracts and revenue, resource management in defined areas) and demonstrates solid subject matter knowledge. Exercises judgment within defined procedures and policies to determine appropriate action. Supervises staff to assure accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental goals and objectives.
• Continuously evaluates process efficiency and challenges the status quo. Drives focus on continuous improvement among direct reports. Helps team members identify and implement process improvement specific to the team and projects. Supports innovation efforts within service and organizationally .
• Decisions and problem-solving are guided by policies, procedures and business plan; receives guidance from senior manager. Maintains high level of confidentiality related to confidential project information and colleagues information. Identifies gaps in processes and guides policy development to address gaps.
• Decisions and problem-solving are guided by policies, procedures and business plan; receives guidance from senior manager or Director.
• Effectively communicates with senior or managerial level peer customers. Clearly articulates regulatory requirements and shares expertise and advises on best practice internally and externally. Presents at the expert webinars and company-wide meetings. Leads team communication related to Business Development activities. Effectively communicates expectations and feedback to direct reports and teams during 1:1 and performance review processes. Communicates in a positive and consistent way that aligns with the organizational objectives, decisions and direction.
• Escalates issues and concerns and suggests solutions through the appropriate leadership channels.
• Accountable for the budget, performance and results of a medium-sized team or multiple small teams of colleagues. Sets priorities for the team based on service line objectives to ensure task completion; coordinates work activities with other managers. Effectively manages and addresses colleagues performance; course corrects and coaches colleagues.
• Responsible for managing resourcing for existing projects and project pipelines. Requires minimal oversight from more senior Managers to ensure resource alignment with team specific projects and project pipeline.
• Develops effective KPIs and scoreboard to ensure teams engagement as it relates to achieving on-time quality deliverables for the customer. Effectively manages customer expectations related to timeline and deliverables.
Requirements:
• Graduate degree in scientific discipline or relevant work experience
• Minimum of 5 years experience in CMC/Nonclinical Writing (in a CRO or Pharma environment preferred)
• Familiarity with ISO 9001:2015 and ISO 27001:2013 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
• Strong understanding of clinical trial development and data
• Excellent scientific writing skills; willing to guide others in a variety of medical writing techniques
• Proficiency with MS Office applications
• Ability to anticipate and effectively resolve potential problems and client demands
• Excellent organizational and communication skills
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Keyskills :
problem solvingmedical writinghigh level of confidentiality21 cfrservice levelproject riskms officeglobal healthwriting skills