Senior Medical Writer (Home Based)

About the role

Please note: This is a home based position - the successful candidate can be based anywhere in the US.

Summary

Serves as a senior medical writer on clinical study or regulatory project teams. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects.

Essential Functions

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas.
• Creates writing deliverables that include, but may not be limited to:
• clinical study protocols and clinical protocol amendments;
• clinical study reports;
• clinical development plans;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and (e)CTD submissions;
• investigator brochures, as well as;
• clinical journal manuscripts, clinical journal abstracts, and client presentations.
• 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.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, 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 requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

Other Responsibilities

Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Requirements

• BA/BS degree in life sciences, clinical sciences, English/journalism, or equivalent related experience.
• Extensive progressive experience in medical and/or scientific writing or equivalent education and experience.
• Advanced degree preferred.
• 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.

Additional Information: Why choose us?

It takes skill and passion to develop medicines the way we do. Don't worry - if you've got the passion part, we'll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.

We've got an attitude at INC: "Can do, I own it." Absolutely everyone has ownership of what they do here. And because we're given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.

"We were ranked "Top CRO" to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide)."

What happens next?