Lifecycle Writer, Strategist – Fixed-term
Xero
Manager, Medical Writing
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $95,000 - $175,700 per year
Job Level
Mid-LevelSenior
Tech Stack
Assembly
About the role
- Project-specific management responsibilities for medical writing staff members.
- Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
- Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
- Reviews and edits departmental work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products.
- Ensures adherence to Sponsor objectives and that quality standards are maintained.
- Supports the company’s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates.
- Assists with the preparation of budgets and timelines for medical writing activities (full-service clinical development projects and stand-alone medical writing projects) as needed.
- Assists with budgeting, revenue, invoicing, and forecasting as requested.
- Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics.
- Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings.
- Builds and maintain relationships with internal and external customers.
- Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise.
- Reviews performance of medical writing personnel (direct reports).
- Develops and maintains departmental SOPs and templates and acts as resource for implementation.
- Participates in the planning, writing, and assembly of medical writing deliverables, as needed.
- Performs senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans and table/figure/listing.
- Performs other work-related duties as assigned.
- Minimal travel may be required (up to 25%).
Requirements
- Bachelor’s degree required with relevant scientific and/or medical knowledge and expertise.
- Experience in medical writing with progressive management experience and experience in a contract research organization or pharmaceutical/medical device company.
- Management experience preferred.
- Extensive knowledge of English grammar required.
- Knowledge of principles of clinical research
- Knowledge of principles of clinical research, including FDA, EU, ICH regulations and guidelines and ISO standards; excellent communication skills.
- Effective presentation, interpersonal, and leadership skills with a team-oriented approach.
- Strong Microsoft Office Suite skills.
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingbudgetingproject managementperformance appraisalSOP developmentstatistical analysisdocument development strategiesclinical research principlesEnglish grammar
Soft skills
leadershipinterpersonal skillscommunication skillspresentation skillsteam-oriented approach
