Manager/Senior Manager, Medical Writing

At Elan, we hold a fundamental belief that our science has the potential to improve patients’ lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.

Elan’s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.

 

Primary Objective of Position:

 

The Senior Manager, Medical Writing, is accountable for all medical writing activities for an individual document within a global development project, and supervises all medical writing resources assigned to that document. S/he also supports other medical writing projects as necessary. Candidates with less experience will be considered for a Manager position.

 

Responsibilities:

 

Under the direction of the Director of Medical Writing, is responsible for:

 

·  As a member of a clinical team, researching, writing, and managing the production of clinical documents and materials, including but not limited to:

 

Investigator brochures, clinical study reports, abstracts, posters, publications, clinical summaries, clinical overviews, protocols, protocol amendments, annual safety updates, and presentations.

· Reviewing analyses and data presentations to be used in study reports or other documents.

· Providing input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines.

· Ensuring that all clinical documents are produced according to appropriate Elan SOPs and business practices.

· Potentially supervising contract medical writers for clinical documents.

· Developing, implementing and using templates and guidelines for clinical documentation. Potentially providing template training to teams.

· Reviewing pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.

· Supporting clinical teams in protocol and CRF development.

 

 

Requirements:

 Senior Manager must have Bachelor’s degree in a science or communication discipline with a minimum of 7 years medical writing experience in the clinical or laboratory setting, OR Advanced Degree with 5 years medical writing experience in a clinical or laboratory settingManager must Bachelor’s degree in a science or communication discipline with a minimum of 5 years medical writing experience in the clinical or laboratory setting OR Advanced Degree with 3 years medical writing experience in a clinical or laboratory setting Good understanding of experimental methods, research design, and statistical analysis. Ability to analyze medical data and interpret its significance within a pharmaceutical setting.  Ability to interpret, analyze, and present statistical data obtained in a clinical trial.  Advanced scientific, technical reading, writing and editing skills.  Excellent oral communication skills. Proficient computer and word processing skills.