Sr Medical Writer (Process Mapping , Scientific Writer)

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program
• We are committed to our Total Self culture where you can authentically be yourself
• Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people
• We are continuously building the company we all want to work for and our customers want to work with
• WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong

Job Responsibilities

• Mentors and leads less experienced medical writers on complex projects, as necessary
• Acts as lead for assigned writing projects
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
• Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc
• , and serves as a medical writer within and across departments with minimal supervision
• Ability to create process maps from provided technical material or from client inputs
• Hands on experience of using MS Visio or similar tools
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
• Serves as peer reviewer on internal review team providing review comments on draft and final documents
• Adheres to established regulatory standards as well as Company Standard Operating Procedures, 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
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
• Maintains awareness of 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
• Performs other work-related duties as assigned
• Minimal travel may be required (less than 25%)

What were looking for

• 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