BioSpace
Principal Strategic Medical Writer (Oncology)
Join to apply for the
Principal Strategic Medical Writer (Oncology)
role at
BioSpace .
Company Description 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 key therapeutic areas, including immunology, oncology, neuroscience, and eye care, and offer products and services in our Allergan Aesthetics portfolio.
Job Description Principal Strategic Medical Writer responsible for creating and managing complex clinical and regulatory documents, working closely with cross‑functional teams, and ensuring high‑quality deliverables that meet regulatory standards.
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: Bachelors degree in a scientific discipline (or foreign education equivalent).
Experience: 5 years of academic and/or industry medical writing experience.
Expertise:
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 ICH & FDA regulatory requirements.
Collaborating 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: $144,715.00 - $202,500.00 per year.
Benefits include paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and short‑term & long‑term incentive programs.
Equal Opportunity Employer. AbbVie is committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion.
How to Apply Apply online at
https://careers.abbvie.com/en
or send your resume to
Job.opportunity.abbvie@abbvie.com . Refer to Req ID: REF45979T.
EEO Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. AbbVie’s policy is to employ qualified persons of the greatest ability without discrimination against any applying for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Additional Legal Information 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 can click here:
https://www.abbvie.com/join-us/reasonable-accommodations.html .
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Principal Strategic Medical Writer (Oncology)
role at
BioSpace .
Company Description 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 key therapeutic areas, including immunology, oncology, neuroscience, and eye care, and offer products and services in our Allergan Aesthetics portfolio.
Job Description Principal Strategic Medical Writer responsible for creating and managing complex clinical and regulatory documents, working closely with cross‑functional teams, and ensuring high‑quality deliverables that meet regulatory standards.
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: Bachelors degree in a scientific discipline (or foreign education equivalent).
Experience: 5 years of academic and/or industry medical writing experience.
Expertise:
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 ICH & FDA regulatory requirements.
Collaborating 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: $144,715.00 - $202,500.00 per year.
Benefits include paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and short‑term & long‑term incentive programs.
Equal Opportunity Employer. AbbVie is committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion.
How to Apply Apply online at
https://careers.abbvie.com/en
or send your resume to
Job.opportunity.abbvie@abbvie.com . Refer to Req ID: REF45979T.
EEO Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. AbbVie’s policy is to employ qualified persons of the greatest ability without discrimination against any applying for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Additional Legal Information 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 can click here:
https://www.abbvie.com/join-us/reasonable-accommodations.html .
#J-18808-Ljbffr