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Senior Medical Writing Specialist

Riverwoods, IL 60015

Posted: 09/10/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614419 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 60-75.53/hr **salary will be commensurate with experience 

Job Description:

The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce clinical documents which support the safety and efficacy of our products. The Senior Medical Writing Specialist in Worldwide Medical Advanced Surgery will write and edit clinical documents to support regulatory submissions for relevant products. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking). \

Essential Duties and Responsibilities:
  • With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
  • Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations, manuscripts/abstracts for publication and/or presentation.
  • Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and procedures (as applicable).
  • Work closely with cross functional team members and serve as MW representative at study team meetings.
  • Prepare document timelines, with guidance from manager, as needed.
  • Conduct literature searches.
  • Develop deeper knowledge of specific therapeutic areas.

Qualifications:
  • Experience in scientific and/or medical writing.
  • Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner.
  • Strong organizational skills and meticulous attention to detail.
  • Familiarity with clinical trial-related and regulatory clinical submission templates and documents
  • Ability to apply global regulatory authority regulations and/or guidance.
  • Manage multiple projects with competing priorities.
  • Experience working in a team environment (remotely) as well as independently.
  • Medical statistics knowledge
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams

Education and/or Experience:
  • The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline with excellent writing skills. 5 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Riverwoods, IL

Ready to find your dream job in the vibrant community of Riverwoods, Illinois? Nestled in the beautiful Lake County, Riverwoods offers a unique blend of city amenities and small-town charm, making it an ideal location for career growth and personal fulfillment. From the stunning landscapes of the Ryerson Woods Forest Preserve to the thriving arts scene at the Deer Path Art League Gallery, this area has something for everyone. Explore job opportunities near iconic landmarks like the Ravinia Festival, indulge in the local cuisine, and catch a show at the Marriott Theatre. Join us in Riverwoods and discover the perfect balance between work and play as you embark on a fulfilling career journey. Start your job search today and unlock endless possibilities in this enchanting region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.