The Lead Senior Medical Writer will play a pivotal role in the research, creation, and editing of essential documents for clinical research. As the primary project writer and coordinator, you will effectively manage contributions from multiple writers while serving as the main client contact. This role also emphasizes process improvement, technical mentoring, and supports management during the sales process through insightful client engagement and proposal input.
Key Accountabilities:
Author Clinical Documents
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Independently gather and analyze resources to prepare high-quality clinical documents for regulatory submission. Take initiative in training yourself and others to develop various medical writing deliverables.
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Revise drafts based on team feedback, ensuring that document updates incorporate all relevant insights.
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Effectively manage ongoing and updated project documentation.
Quality Control
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Verify that all outputs are complete and of superior quality before team distribution or client delivery.
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Lead technical quality assurance to comply with regulatory guidelines and submission goals.
Project Management
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Exercise leadership as the project lead and primary client liaison, managing contributions from multiple writers. Oversee the project scope, timeline, and client communications.
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Develop and coordinate work plans for document delivery, ensuring efficiency in meeting project milestones.
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Provide strategic leadership to delegate tasks and monitor project progress while maintaining clear communication with all stakeholders.
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Continuously assess project performance, adapting strategies as needed to achieve on-time and within-budget completion.
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Maintain transparency about project status to clients and team members.
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Utilize expertise to analyze and deliver critical information across documents and projects.
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Cultivate collaborative and professional relationships to enhance team and client engagement.
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Monitor and address project budget variances and propose corrective measures as necessary.
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Provide consistent updates to management regarding project status, resource needs, and creative solutions for shifting requirements.
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Communicate effectively with team members and provide feedback regarding their performance and development needs.
Client Liaison/Service
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Understand and respond to client expectations and manage any incidents of dissatisfaction effectively.
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Support business development efforts by identifying new leads and contributing to pitches as appropriate.
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Offer strategic insights during the proposal generation process to guide services offered to clients.
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Contribute insights into proposal development utilizing established templates and standards.
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Provide resource recommendations for comprehensive and stand-alone projects.
Training/Compliance
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Stay updated on advances in medical writing and regulatory guidelines.
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Train and mentor Medical Writing Services staff to elevate the quality of writing and project execution.
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Ensure compliance with departmental SOPs and contribute to their development and revision.
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Design and deliver external training sessions as needed.
General
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Participate in departmental and company meetings as necessary.
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Adhere to all departmental processes, completing necessary documentation and workload trackers.
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Examine workflow efficiency and discuss improvement ideas with the management team.
Skills:
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Exceptional communication, negotiation, and interpersonal skills.
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Adaptable and flexible approach to work assignments and performance.
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Strong motivation to thrive in a dynamic, fast-paced environment.
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Effective organizational skills and attention to detail, with the ability to juggle multiple tasks.
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Experience in working collaboratively within a matrix environment and leading teams successfully.
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Sound judgment with the ability to address project-related issues appropriately.
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Proven ability to advocate for medical writing needs to ensure alignment of resources and timelines.
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Capacity to fulfill and exceed client requirements, fostering strong relationships.
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Committed to building trust and delivering excellent service beyond individual projects.
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Provide valuable insights to enhance business opportunities and strategy formulation.
Knowledge and Experience:
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In-depth understanding of clinical research and the drug development process, including regulatory guidelines.
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Extensive experience in drafting clinical regulatory documents and managing complex writing projects.
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Familiarity with resource management and productivity metrics.
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Advanced skills in MS Office, especially Word, and the ability to navigate various IT systems.
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Willingness to travel as required.
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Fluency in written and spoken English.
Education:
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Bachelor's degree in Life Sciences, Health-related Sciences, or a comparable field.
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Parexel is committed to equal opportunity employment. Qualified candidates will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.