Sr. Medical Writer III -Pharmaceutical Industry

We are excited to offer a part-time (20hrs/week) & work remotely role at a biotechnology company that provides initiation of clinical trials for neurodegenerative diseases located in San Carlos, CA.

Job Title: Sr. Medical Writer (work remotely)

Term: 6-Month, Part-Time (20hrs/week) with the possibility to increase hours

Job Summary:

We are seeking an experienced Medical Writer for part-time (20hrs/week) to join an energetic and collaborative Development Team working at a fast-paced, growing company. The candidate will work with doctors, scientists, and other subject matter experts to create documents that effectively and clearly describe research results, product use, and other medical information. The ideal freelance Medical Writer must have an advanced degree (PhD/MD) and have relevant writing experience for neurology, dermatology or ophthalmology products. The candidate can will work remotely but may need to come on site occasionally.  

Primary Responsibilities:

  • Write clinical documents including protocols, IBs, CSRs
  • Write regulatory documents including INDs, eCTD/ NDAs (including ISS, ISE, Clinical and Non-Clinical overviews, QOS), briefing books, DSUR, IND annual reports
  • Analyze, interpret and present clinical data and other complex information
  • Prepare scientific literature searches, abstracts, posters and manuscripts
  • Lead document review and comment adjudication meetings with cross-functional teams
  • Manage the writing process efficiently to ensure timely completion of high-quality, submission-ready documents
  • Participate in meetings involving aspects of medical writing (e.g. core project teams, publication planning, regulatory submissions planning)

Skills/Experience:

  • PharmD, PhD or life sciences degree with a preferred minimum of 8 years’ experience in medical writing
  • Thorough understanding of CFR and ICH guidelines
  • Strong communicator with meticulous attention to detail, solid writing and organizational skills
  • General understanding of disease areas (neurology, dermatology, ophthalmology) and blood products.  Experience is a plus.
  • Exposure to the pharmaceutical and healthcare industry with good understanding of global pharmaceutical drug development requirements for submissions, basic knowledge of document publishing process.
  • Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
  • Understanding of documentation requirements related to submission of manuscripts to scientific and medical journals
  • Superior computer skills, including high-level word processing and graphic presentations
  • Experience with Microsoft Office including PowerPoint required

 

Apply Now!

This is a six-month contract role, part-time with possibility to increase hours after completion of the first project.  Remote work is allowed. 
 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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