Principal Medical Writer - Single Sponsor - CTD Documents Lisboa

Overview

Principal Medical Writer - Single Sponsor - CTD Documents

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers the customer and the patient. We seek to simplify and streamline work to be easier to work with and to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies to change lives.

Work here matters everywhere. Why Syneos Health: we develop our people through career development, training, and rewards; we foster a Total Self culture; and we value diversity of thoughts and backgrounds to create belonging.

Job Responsibilities

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Represents the Medical Writing department on clinical study teams, at conferences, meetings and for client presentations regarding a writing project.
• Advises clients and study teams on data presentation and production strategies to meet client objectives and maintain quality standards.
• Develops good working relationships with internal and external colleagues.
• Manages medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision.
• Develops or supports a variety of documents, including but not limited to: clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD submissions; investigator brochures; clinical journal manuscripts, abstracts, and client presentations.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Provides peer review comments to ensure clarity, accuracy, relevance and alignment with client objectives and quality standards.
• Adheres to regulatory standards (ICH-GCP/ICH guidelines) and company SOPs, templates, and client standards when completing medical writing projects, on time and on budget.
• Performs online clinical literature searches as applicable.
• Continues professional development to stay current with regulatory guidance and client expectations affecting medical writing.
• Understands budget specifications for assigned projects, works within budgeted hours, and communicates changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other
  - related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Ability to lead and align teams in achieving project milestones
• Capable of working in an international environment
• Previous clinical trial experience in site management
• Preferred experience with
  - based monitoring and clinical or central monitoring
• Familiar with financial principles and budget management practices
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills
• Strong communication, presentation and interpersonal skills among project team and sites
• Basic conflict resolution skills
• Ability to apply
  - solving techniques to resolve complex issues and use a risk management approach
• Demonstrates critical thinking to determine root cause and appropriate solution
• Moderate travel may be required, approximately 20%

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Marketing, Public Relations, and Writing/Editing

Additional Information: Tasks, duties and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. The Company will determine what constitutes an equivalent qualification. This content is intended to comply with applicable laws and regulations. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.