Medical Writer II

The Medical Writer will primarily work on the development and delivery of high-quality documents such as Clinical protocols, protocol amendments, Investigator’s Brochures (IBs), non-clinical and clinical summaries together with integrated summaries (ISS and ISE), and other related clinical/regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications (NDAs) and Biologics License Applications (BLA) within agreed-upon timelines.

Education and Credentials

• Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment
  
• Bachelor’s degree in life sciences or related disciplines; advance degree preferred (MD, PhD, PharmD, etc.)
  
• Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus.
  

Skills

• Ability to work independently and collaboratively in a team environment consisting of internal and external contributors
  
• Experience in managing multiple projects simultaneously
  
• Excellent problem-solving skills with the ability to adapt to changing priorities and deadlines.
  

• Excellent interpersonal skills and ability to work with cross-functional teams to meet business objectives.
  
• Ability to initiate and generate with limited supervision medical, regulatory, and clinical documents within a reasonable timeframe
  
• Ability to develop document templates for ongoing and future submissions depending upon the scope of the project.
  
• Ability to pivot from one project to another and multitask
  
• Ability to understand client objectives and provide feedback that supports projects and deliverables in multiple therapeutic areas
  
• Ability to move efficiently in a dynamic environment
  
• Excellent verbal and written communication and listening skills.
  
• Highly proficient with Microsoft Office.
  
• Effective time management
  
• Bilingual in Mandarin and English is not required, but will be a plus
  

Responsibilities

• Prepares, edits, and finalizes various documents, medical and technical from non-Clinical / pre-clinical to Phase IV studies.
  
• Serves as medical writing representative on cross-functional study teams and provides guidance on document strategy and content, timelines, and resource needs
  
• Manages the document development process from start to finish which may include generating multiple draft documents and formulating final approved versions, editing, reference retrieval, as well as managing other various processes are undergone (i.e., internal & external reviews, quality checks, audits, formatting, publishing).
  
• Collaborates with cross-functional team to ensure results and statistical interpretations are accurately and clearly reflected in documents.
  
• Participates in all necessary cross-functional document development meetings (i.e., kick-off meetings, comment resolution meetings) to ensure appropriate alignment from different stakeholders.
  
• Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables.
  
• Monitors regulatory, clinical/medical, and scientific findings and conclusions ensuring key messages are clear and consistent within and across documents.
  
• Provides editorial or review support for other types of documents as requested.
  
• Maintains ongoing familiarity of US and international regulations, requirements and guidance associated with the preparation and submissions of clinical regulatory documents and scientific publications
  
• Proponent of Good Publications Practice Guidelines and understand the importance of adhering to the rules and regulations of External Scientific Professional Organizations and scientific journals.
  

Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BA, BS, RN, BSN or equivalent
  
• Basic knowledge and adherence to GCPs
  
• 5 years of clinical research experience
  
• Strong attention to detail
  
• Ability to multi-task
  
• Unquestionable integrity and highest ethical standards
  
• Excellent written and verbal communication skills
  
• Self-motivated, assertive, and driven
  

Benefits