Under minimal supervision, the Medical Writer critically evaluates, analyzes, and interprets the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.

Summarized Purpose:

Utilizes professional judgment and creative expertise to integrate the pertinent clinical data into an original summary document that is clear, accurate, concise, comprehensive, and devoid of promotional overtone. Provides evaluation of medical communication instruments and makes recommendation for corrective action. Assumes responsibility for ensuring that the finished document is complete, accurate and complies with approved format.

Essential Functions:

• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.

• Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.

• Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.

• Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.

• May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.

• Represents the department at project launch meetings, review meetings, and project team meetings.

  
  

Education and Experience:

• BS degree in pharmacy or Doctoral level degree in a biomedical field
• 2 years experience in searching the biomedical literature
• 2 years experience in interpreting and using medical communication documents
• Experience within regulatory medical writing (comparable to 2+ years)

Knowledge, Skills and Abilities:

• Knowledge of biomedical and pharmaceutical databases (e.g. MEDLINE, CANCERLIT, EMBASE, BIOSIS, IPA) and vendors for accessing them (e.g. DIALOG, OVID, SILVERPLATTER)
• Knowledge of Boolean logic/operators
• Knowledge of medical terminology and basic statistical/clinical concepts
• Problem-solving capabilities and excellent organizational skills
• Excellent grammatical and communication skills
• Writer skills, i.e. command of outlining, drafting, revising, and reviewing
• Basic editorial and proofreading skills
• Detail-oriented.
• Able to work with minimal supervision
• Ability to prioritize
• Adaptable and flexible in nature
• Computer skills [word processing, spreadsheet, bibliographic management]
• Good interpersonal skills.
• Ability to work within a team

Working Environment:

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.