₋ 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 presentations to the client regarding a writing project.

₋ Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.

₋ Develops good working relationships with internal and external colleagues.

₋ Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.

₋ Develops or supports a variety of documents that include, but not limited to, clinical journal manuscripts, slide sets, and conference abstracts, posters and presentations.

₋ Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

₋ Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.

₋ Adheres to established regulatory standards, including but not limited to GPP3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.

₋ Performs on-line clinical literature searches, as applicable.

₋ Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.

₋ Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

₋ Completes required administrated tasks within the specified timeframes.

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise .

• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.

• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.