Senior Medical Writer

Apex Systems
Full time
Copywriting and Editing
United States
Hiring from: Anywhere

Remote Senior Medical Writer



  • Employee Type: Contract

  • Job #: 1095484

  • Apex Systems is seeking a Senior Medical Writer to work remotely and must be based in the U.S.

  • For immediate consideration, please email Nick, at nkreutz@apexsystems.com.


Responsibilities:



  • Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically-oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, agency RTQs, and eCTD summary documents for IND, NDA, MAA, BLA and biosimilar BLA applications and amendments.

  • Interpret data, search and analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.

  • Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.

  • Manage and direct client project teams, including identifying, directing, and delegating tasks necessary for successful document completion.

  • Interact directly with clients and contractors; participate in and lead discussions during meetings.

  • Collaborate with project teams to respond to heath authority questions and requests.

  • Collaborate and help other medical writers in the writing, editing, QC review and compilation of documents.

  • Prepare and manage project plans and timelines.

  • Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously and reorganize and reschedule work as needed in order to meet client deadlines.

  • Understand and support the nature of the business and the company’s commitment to quality and responsiveness.

  • Proactively develop/maintain technical knowledge, remain up-to-date on current trends and best practices; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance.


Qualifications:



  • PhD, PharmD, MS, BS, RN, or RPh in a relevant scientific or pharmaceutical discipline

  • 10+ years of experience in the Pharmaceutical industry with 6+ years of experience in medical/regulatory writing/editing required.

  • Experience with biosimilars and BLAs preferred.

  • Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles.

  • Understanding of medical terminology and statistical methodology is a must.

  • Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries for INDs, NDAs, BLAs, and integrated summaries of safety and efficacy.

  • Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as edit on all levels, from copy editing to major rewriting.

  • Experience and proficiency with document templates and proper version control.

  • Demonstrated leadership capability with good team player characteristics.

  • Excellent communication and interpersonal skills.

  • Strong project management skills.

  • Must be organized and self-motivated with strong attention to detail.


How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Technical Writer, Education Remote OK Full-Time Job Openings Technical Writer, Education Amplified IT is looking for a Technical Content Writer on our Delivery team reporting into the Logistical Lead. In this position, you will create easy-to-understand customer content to increase...
Copywriting and Editing
United States
Hiring from: Anywhere
Narcity Media
Full time
Deputy Editor, USA Editorial Full Time USA, Remote Who We Are: Narcity Media is a digital-only news & travel network that reaches over 23M people monthly. We are a group of passionate and creative individuals who are devoted to creating...
Copywriting and Editing
United States
Hiring from: Anywhere
R&Q - Regulatory and Quality Solutions
Full time
Medical Writing Talent Community –¬†Remote MULTIPLE STATES FULL-TIME Welcome to the R&Q Solutions Talent Community! Our talent community is designed to be a network of candidates that are interested in potential future opportunities with R&Q. By joining a particular...
Copywriting and Editing
United States
Hiring from: Anywhere
MicroTasks.io

Share you skills and get paid!

All from the comfort of your home.

LEARN MORE