Job Description

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.

Job Tags

Similar Jobs