|Description: Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas of cardiovascular disease, diabetes, pediatric conditions, and women’s health. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people's health for over 130 years.
We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future.
The Senior Medical Writer will be responsible for:
---Writing, editing, reviewing, and formatting high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products across multiple therapeutic areas as assigned.
---Providing training support for Medical Writing-related procedures and templates across the organization.
DUTIES AND RESPONSIBILITIES
· Works independently to write and edit clinical study reports, Investigator’s Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents. 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.
· Work within a cross-functional team of physicians, statisticians, regulatory
and clinical development staff to prepare briefing documents, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents as needed -
· including manuscripts, and external and internal presentations.
· 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.
· Create and maintain clinical document templates and company style guides in accordance with regulatory guidelines and requirements
· Research and summarize relevant literature references. Implement and
monitor adherence to standards, processes, and industry best practices.
· Maintain up-to-date knowledge of standards and procedures for clinical and regulatory documents (including eCTD) in the US, Europe, and other countries.
MINIMUM JOB REQUIREMENTS
· BS or equivalent required. Advanced life science (PhD, PharmD, MS) or medical (MD, DO) degree is preferred.
· Minimum of 5 years of medical writing experience supporting clinical development activities within the pharmaceutical/biotech industry along with the interest and ability to work under tight deadlines while coordinating multiple projects.
· Strong background in clinical therapeutics and critical analysis;
· An understanding of clinical pharmacology, clinical research methodology and biostatistics is mandatory.
· Excellent project management and organizational skills;
· Detail-oriented team player capable of multitasking and prioritizing;
· Adaptable to changing priorities;
· Strong interpersonal and written/verbal communication skills.
· Excellent clinically oriented writing, editing, client management skills.
· Proficient in the use of common Microsoft software programs.
PREFERRED SKILLS AND EXPERIENCE
· Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure.
· Experience developing eCTD-compliant documents is a plus.
· Ability to critically analyze, synthesize, and communicate/present complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
· Excellent writing, editing, verbal, and interpersonal communication skills, and strong attention to detail.
· 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 facts-paced environment.
Our employees are considered the most valued part of our organization. We demonstrate this commitment to our employees by offering a competitive salary and a comprehensive employee benefits package.
To be considered for this position, you must apply online at www.shionogi-inc.com and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
Shionogi Inc. is an equal opportunity employer – proud to support diversity in the workplace.
Shionogi Inc. does not accept unsolicited third party resumes.
State or Province