Job Description

MUST HAVE EXPERIENCE WITH "MOST" OF THE FOLLOWING: - NDAs - MAAs - eCTD - PSURs (Periodic Safety Update Reports) - PBRERs (Periodic Benefit Risk Assessment Report) - DSURs (Development Safety Update Reports) - Submissions (IND/IMPD/NDA/MAA/sNDA) - Risk Management Plans (RMPs) - Regulatory - Clinical study reports - Drug Safety-related documents - Clinical trial reports - Appendices - Investigator’s Brochures

• Clinical Expert Statements JOB PURPOSE: The Medical Writer Contractor is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of Drug Safety-related documents. The “hands-on” Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. The responsibilities also include the coordination and preparation of Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, investigator brochures for Phase I to IV clinical trials, and drug safety related documents. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired. Non-project activities also include Data Disclosure, Eudra-CT, ClinTrial.gov. ESSENTIAL ACTIVITIES, DUTIES, TASKS AND RESPONSIBILITIES:

• Prepare/coordinate clinical documents as required e.g., Clinical Trial Reports (Phase I – IV) with associated appendices, Investigator’s Brochures, Clinical Expert Statements/ Addenda to Clinical Overviews for product renewals, and Drug Safety-related documents such as Periodic Safety Update Reports (PSUR/PBRERs), Development Safety Update Reports (DSURs) and Risk Management Plans (RMPs).

• Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians, data managers and drug safety group) as applicable. Discuss the objectives, timelines, and documents to be generated, coordinate contributions from other groups and prepare the documents in an efficient manner for submissions to regulatory authorities.

• Resolve conflicting comments among reviewers.

• Manage projects within time constraints.

• Provide status reports for ongoing projects.

• Act as a Medical Writing coordinator for the preparation of Drug Safety-related documents such as PSUR/PBRERs.

SECONDARY ACTIVITIES, DUTIES, TASKS AND RESPONSIBILITIES:

• Review medical documents generated outside of Medical Writing (e.g., study protocol, Statistical Analysis Plan, tables and listings).
• Prepare/review SOPs, Working Guides, and document templates.

PROFESSIONAL EXPERIENCE:

• 7-10 years of experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers. In addition, experience in the preparation of drug safety related documents is strongly preferred.
• Experience with diagnostic imaging agents preferred.
• Experience working with an electronic based document management system.
• Experience with interactions with regulatory groups and formulating regulatory strategies desirable.

EDUCATION:

• B.S. degree required, advanced degree/Life Sciences preferred.

The position is home based. #Mon-SPG #IND-SPG #LI-SPG #Zip-SPG #CB-SPG

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

Company Description

Investment Management Company