Serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as a primary technical contact with the internal team and the client.
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.
Develops or supports a variety of documents that include, but not 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.
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 the department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as a peer reviewer on the internal review team providing review comments on draft and final documents.
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 online 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.
Desired Candidate Profile
Minimum 5 Years of experience in Regulatory Medical Writer Role
Should have Authored P II - III CSR or Protocol documents
Should have worked on ICF or IB Documents
Should have experience in Leading the Project or Client
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You will work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA, and at least 70% of products granted marketing authorization by the EMA.