Clinical Writer Job

CLINICAL WRITER needed for a contract opportunity with Yoh's client located in WAUKESHA, WI

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Five years of medical writing experience
- Knowledge of ICH and other regulatory guidelines
- Experience working with regulatory agencies

WHAT YOU'LL BE DOING:

- The Clinical Writer partners with Subject Matter Experts, Medical Directors and clinical team to create clinical study related documents in accordance with ICH, regulatory authority, and/or corporate guidelines.
- Creates a variety of clinical documents necessary for all phases of clinical research by organizing, analysing, and interpreting scientific and statistical data.
- May also assist with regulatory submissions and will conduct medical literature searches as required.
- Create clinical study related documents in accordance with ICH, regulatory authority, and/or Corporate guidelines including: clinical study reports, study protocols, informed consent forms and other clinical documents as applicable
- Works with manager and Clinical Affairs Project Manager to ensure research activities are run compliantly and according to project timelines.
- Attend internal and external meetings as necessary for each project (eg, Project Kick-off meeting, Sponsor team meetings, Project team meetings)
- Provide direction and advises management regarding project resource requirements, and manages project-related activities of resources assigned.
- Reviews statistical analysis plans and case report forms, as required.
- Performs quality control (QC) review of clinical study protocols and other submissions written by other medical writers.
- Keeps management informed on progress on documents and other project related information, assist management in projecting resources, and perform administrative duties as requested.
- Documents are to be completed within a time period that supports project needs and deadlines
- Documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers
- Work with Clinical Affairs Project Manager and other members of the study team on full service projects
- Conduct medical literature searches as required
- Some travel may be required

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree (or internationally recognized equivalent) in a life sciences or biology discipline plus a minimum of 5 years experience BS/BSc/BA in a science or industry-related discipline with a minimum of 5 years of medical writing experience, specifically writing such documents as clinical study protocols, informed consent forms, clinical study reports, etc.
- Working knowledge of ICH and other regulatory guidelines.
- Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.
- Proficiency in Microsoft Word

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- An advanced degree, (Masters, PhD.)in a life sciences or industry-related discipline.
- Ability to travel (occasional)
- Experience conducting medical literature searches, analysing and writing reports on the results of such searches
- Knowledge of Quality Management Systems (QMS).
- Experience working across cultures/countries/sites.
- Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
- Demonstrated ability to work well independently & in a team setting.
- Strong problem solving, influencing and negotiation skills.
- Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner

IF THIS SOUNDS LIKE YOU, APPLY NOW!

RECRUITER: Patrick Lindsley

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL, PROF, MONJOB

TAX TERM: CON_W2J2WNWPHA

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SFSF: HC