Principal Strategic Medical Writer (Oncology)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

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.

Education & Experience

Must have a Bachelor’s 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:

1. preparing & presenting written & oral scientific presentations to peers, business stakeholders & management;
2. interpreting statistical data to prepare written medical and scientific reports for regulatory bodies;
3. clinical regulatory writing experience following regulations ICH & FDA regulatory requirements;
4. working with stakeholders in drug development, clinical research, study designs, & biostatistics to author clinical regulatory documents;
5. performing medical writing in the bio-pharmaceutical industry; &
6. managing project delivery timelines.

Work experience may be gained concurrently.

100% Telecommuting permitted.

Salary Range: $144,715.00 - $202,500.00 per year.

Apply online at https://careers.abbvie.com/en or send resume to [email protected]. Refer to Req ID: REF45979T

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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 AbbVie’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html