Synterex - Manager Medical Writer - Remote
Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.
Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The Manager, Medical Writing will report to the Executive Director of Medical Writing and Quality Assurance and will be responsible for the coordination, management, and growth of Medical Writing team members and vendors/contractors. The Manager, Medical Writing will maintain optimal department processes, implements project-specific strategies, and assists with the development and implementation of department strategies to increase productivity and quality.
This is a full-time position.
Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.
Essential Duties & Responsibilities:
- Manage direct reports, coordinate resources, and develop work plans that align with internal and external goals and timelines
- Oversee quality output of deliverables delegated to Medical Writing personnel and vendors
- Ensure that all clinical regulatory documents:
- Comply with international, national, and pertinent local regulations
- Adhere to SOPs and guidance documents (internal and/or external)
- Are completed according to timelines
- Liaise with Executive Leadership team to report on and optimize staff utilization and other key performance indicators (KPIs); record and utilize metrics to inform KPIs
- Support Medical Writing and Business Development leadership in preparation of work orders, budgets, invoicing, and forecasting
- Coordinate with Business Operations to answer customer inquiries and enhance time reporting processes
- Provide guidance and leadership for document development for regulatory writing deliverables, including resource requirements
- Ensure quality and consistency of style, format, and content for all documents
- May assist in the planning of clinical protocols and amendments, clinical study reports, summaries of safety/efficacy, other regulatory documents (annual reports, briefing documents), safety reports, patient narratives, and investigator brochures/updates as needed
- Bachelor’s degree (in life sciences preferred)
- At least 2 years of experience managing an operational team; healthcare, information technology (IT), or a related life sciences team preferred
- Project management experience or certification preferred
- NetSuite or equivalent advanced project managements systems experience preferred
- Exceptional communication and interpersonal skills
- Excellent organizational skills to coordinate resourcing across multiple projects
- Proficient with Microsoft Word, Excel, Project, and PowerPoint
- Familiarity with GCP, 21 CFR, CTD, ICH guidelines/regulations, and the drug development process is a plus
For further information please apply at https://synterex.bamboohr.com/careers/94?source=aWQ9OA%3D%3D
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.