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 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.

Job Description

The Senior Principal Medical Writer is responsible for writing and leading complex clinical documents and clinical documents for regulatory submissions. Provides scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with functional groups (e.g. PK, Toxicology, Regulatory, Statistical Support, Data Management, Clinical) and writers (internal and external vendors) to ensure timely completion of projects that are scientifically accurate and of high quality. Serves as the scientific writing content expert for the department. Addresses and resolves product area issues. Contributes to process improvement activities.

Responsibilities:

• Serves as medical writing lead on complex scientific publications or clinical regulatory documents.
• Leads clinical documents and document teams for regulatory submissions.
• Provides direction, guidance, and mentoring to medical writers regarding assigned projects, including review of work product.
• Provides input and feedback to management regarding internal medical writers regarding work.
• Works closely with the Publications or Regulatory team(s) on document strategies.
• Implements all activities related to the preparation of scientific publications or clinical regulatory documents.
• Coaches, mentors, and assists medical writers.
• May provide guidance to external vendors.
• Converts relevant data and information into a form that meets clinical regulatory document requirements.
• Explains data in a manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements.
• Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects.
• Arranges and conducts review meetings with the team.
• Ensures required documentation is obtained.
• Maintains expert knowledge of US and international regulations, requirements, and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
• Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively.
• Learns and applies knowledge of therapeutic area and product to scientific publishing projects.
• Knowledgeable about the product/disease state and is an expert on clinical documents.
• Continually trains/is compliant with all current industry requirements as they relate to clinical regulatory submissions.
• Responsible for effective communication to team members.
• Communicates deliverables needed, writing process, and timelines to team members.
• Holds team members accountable to agreed-upon project dates.
• Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
• Identifies and resolves conflicts (including document content issues), removes barriers, generates innovative ways to ensure teams achieve project goals.
• Understands, assimilates, and interprets sources of information.
• Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables.
• Verifies that results are consistent with protocols.
• Confirms completeness of information to be presented.
• Challenges conclusions when necessary.
• Independently resolves document content issues and questions.
• Provides project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, including submissions, ensuring accuracy and adherence to timelines and processes.
• As assigned, mentors and provides guidance to medical writers.
• Oversees writing projects to ensure timeline completion.
• Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals.
• Works directly with team members to develop/implement timelines to meet desired project completion dates.
• Coordinates activities and communications with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, Safety Team on writing projects/submissions.
• Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge
• Arranges and conducts review meetings with the team.
• Acts as an interface to resolve issues and questions arising during the writing process.
• Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with the team to draft responses as necessary.
• Recommends, leads, and implements tactical process improvements within the department.
• Leads departmental initiatives.

This role can be based remotely within the US.

Qualifications

Qualifications:

• Bachelor degree in English or Communications with relevant science expertise or Bachelor degree in Life Science with relevant writing expertise.
• Advanced degree and/or professional certification/credentials preferred.
• Demonstrated leadership and proficiency in or willingness to learn required systems.
• 4+ years relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support; 2 years in a project management role required.
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
• Demonstrated experience writing complex documents and demonstration of superior team management.
• Experience in working with collaborative, cross-functional teams, including project management experience.
• Ability to understand and interpret medical data and create and develop strategic messaging required.
• Microsoft Office and Internet navigation proficiencies essential.
• Working knowledge of statistical concepts and techniques required.
• Working knowledge of other business-related information technology.
• Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment. Identify and employ rigorous logic and methods to independently and effectively solve difficult problems within and outside routine work situations.
• Recognize potential scheduling and resource conflicts for project and provide recommendations to resolve.
• Probe multiple sources for answers. Identify hidden issues and problems beyond the obvious. Appropriately identify when to independently address the situation and when to elevate the issue to management and/or development team(s) for resolution.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• 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 incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and 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.

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