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27 days old

Medical Writer Senior Manager

Kelly Services
Cleveland, OH 44101
Senior Manager Medical Writer position available with a growing biotech company in the Cleveland area.



Leadership opportunity to support the Regulatory Affairs department in a growing clinical development company known for their advancement in therapeutic products.



**WE ARE SEEKING:** A **Regulatory Operations, Medical Writer Sr. Manager** to work within Regulatory Affairs for preparing submissions to various regulatory agencies and collaborate with other departments for this publicly traded, dynamic biotechnology company. The Regulatory Operations, Medical Writer Sr. Manager is responsible for all activities related to editing or the creation of high-quality documents, in collaboration with subject matter experts (SMEs), for regulatory submissions to health authorities.








+ Work with SMEs, review, write, edit, and summarize CMC, pre-clinical and clinical data and create documents with scientific and editorial accuracy in compliance with eCTD regulatory requirements and guidance. This includes:

+ Review documents prepared for submissions (including checking numbers, grammatical, clarity and accurately editing, and formatting content).

+ Review nonclinical reports, check bookmarks and hyperlinks in finalized reports, provide editing and formatting help to authors of different sections of regulatory submission documents as needed.

+ Review nonclinical and clinical protocols as part of protocol reviews; review submissions to Clinical Trials.gov.

+ Review clinical study reports, provide editing and formatting help to authors of different sections of regulatory submission documents as needed.

+ Prepare sections of orphan drug applications, PIPs, INDs, Scientific Advice packages, annual reports and other documents, as needed.

+ Order publications and other literature references as needed for submissions.

+ Prepare/update list of abbreviations for documents, check references in text versus in reference list and resolve all discrepancies

+ Bachelors degree in a scientific, pharmacy or related discipline. Masters or PhD degree in a related field a plus;

+ 8-12 years of Medical Writing experience in a regulatory environment with large pharma or Biotech;










**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-10-25 Expires: 2019-11-25

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Medical Writer Senior Manager

Kelly Services
Cleveland, OH 44101

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