Medical Writer - Northbrook, United States - Randstad Life Sciences US

Description

A pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. Currently, the focus is on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells to produce cells that avoid rejection and can be used in allogeneic cell therapy treatments to treat all patients that need them.

We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. Through our diversity, scientific knowledge, professional rigor and focus on innovation, we are merging our technology with the Astellas drug development expertise to unlock cures to many therapies.

KEY SKILLS;

CLINICAL REGULATORY DOCUMENTS

CLINICAL STUDY REPORTS

MEDICAL WRITING

CLINICAL REGULATORY SUBMISSIONS

Job Description:

Major Duties and Responsibilities:

May include but not limited to the following:

• Works independently to write and edit clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas as assigned. Works with contract writers as needed for the timely delivery of assigned documents.
• Reviews clinical protocols, Statistical Analysis Plans, Statistical Programming Plans, data tables and listings, and other clinical regulatory documents as needed.
• Assists with the preparation of briefing documents, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents as needed.
• Demonstrates critical thinking in the analysis and presentation of clinical study data.
• Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
• Provides QC support for clinical regulatory documents as needed.
• Assists with the preparation or revision of SOPs, WPDs, and document templates. Assists with training across functional areas for the implementation of new/revised procedures and templates.
• Participates in Clinical Trial Team meetings and other cross-functional team meetings.
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.

Requirements:

Education:

• Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience. MS or PhD in biological science preferred.

Experience:

• 6 + years experience writing high-quality clinical regulatory documents including clinical study reports across multiple therapeutic areas. Experience writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions required
• Pharmaceutical industry experience required
• Background in biologics a plus

Special Skills:

• Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details
• Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure
• Ability to critically analyze, synthesize, and communicate/present complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas
• Ability to adapt and work through conflicts to create consensus
• Proficiency in Microsoft Office applications
• Familiarity with CTD, ICH, GCP and other standards
• Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment