Principal Strategic Medical Writer (Oncology)
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
29 days ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities
- Serve as a lead on complex clinical & regulatory documents.
- Work closely with the team(s) on document authoring & content strategies.
- Coordinate review approval & quality control of other functions involved in the production of clinical & regulatory projects.
- Communicate deliverables needed writing process & timelines to team members.
- Hold team members accountable to agreed-upon project dates.
- Work independently with Regulatory Quality Assurance to address inquiries & draft responses.
Qualifications :
Education & Experience
Must have a Bachelors degree in a scientific discipline or foreign education equivalent & 5 years of academic &/or industry medical writing experience.
Of experience required must have 3 years with each of the following:
- preparing & presenting written & oral scientific presentations to peers business stakeholders & management;
- interpreting statistical data to prepare written medical and scientific reports for regulatory bodies;
- clinical regulatory writing experience following regulations ICH & FDA regulatory requirements;
- working with stakeholders in drug development clinical research study designs & biostatistics to author clinical regulatory documents;
- performing medical writing in the bio-pharmaceutical industry; &
- managing project delivery timelines.
Work experience may be gained concurrently.
100% Telecommuting permitted.
Additional Information :
Salary Range: $144715.00 - $202500.00 per year.
Apply online at or send resume to . Refer to Req ID: REF45979T
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
