Kelly Science & Clinical ®is seeking an experienced Sr. Medical Writer for a short term contract with a Global Biotech Company.
Job Title: Sr. Medical Writer Specialist in Worldwide Medical Advanced Surgery
:
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 Baxter 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 Mircosoft Office Suite Word, Excel, PowerPoint, OneNote, Outlook, TeamsEducation 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
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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