AbbVie

Director, Medical Writing

Employer
AbbVie
Location
Madison, New Jersey
Posted
Jul 09, 2021
Ref
2110978
Required Education
Bachelors Degree
Position Type
Contract
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

This position can be remain virtual with the ability to travel as needed.

  • Serves on division-level task forces representing therapeutic area(s) for development of clinical writing best practices and migration to eCTD and other future initiatives while also directly leading Sr. Managers, Medical Writing /Writers located in geographically dispersed locations in US and assisting in selection/supervision of agencies/freelance consultants/vendors.
  • Provide leadership in regulatory document development and submission strategy and expertise in project management of documents for multiple compounds and regulatory submissions.
  • Interface with internal stakeholders to ensure accurate and timely completion/delivery of information and review of regulatory submissions.
  • Determine outsourcing strategy and ensure appropriate expectation is set with vendors through leadership, oversight and guidance to Sr. Managers Medical Writing responsible for implementation of outsourcing strategy.
  • Support scientific and marketing objectives for multiple compounds through coordination, preparation and approval of scientific documents within the GPT through expertise in successful management and execution of clinical writing/processes.
  • Execute effective delegation, oversight, and mentoring of Sr. Managers, Medical Writing, permanent in-house medical writers and contract writers for documents, while working with GPTs and functional areas to develop project objectives/strategies and corresponding timelines/milestones.
  • Develop and apply expert knowledge of international regulations, requirements, and guidelines that apply to the preparation/production of submission-ready clinical documents.
  • Collect appropriate metrics, as established by the Medical Writing organization to ensure a high level of internal writing performance and adherence to pharma industry standards (i.e. speed, volume, quality, complexity).
  • Work closely with the Director, Medical Writing to identify and implement measures and activities to grow business and expand department’s influence and visibility.
  • Responsible for effective communication among team members, including outsourced resources. Holds team members accountable to agreed-upon project dates

Qualifications
  • Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
  • 5-10 years of relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/R&D.
  • Minimum 3-5 years of project management experience, preferably with regulatory document project management and 3 or more years of writing/editing/reviewing experience, preferably in healthcare industry.
  • Ability to negotiate with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
  • Ability to make decisions and chart courses through careful evaluation of risks and benefits with limited information and limited supervision. ·
  • Ability to build cross-functional relationships and lead team meetings to address specific projects and hold team members to the project tasks and deliverables.
  • Must be able to resolve conflicts, remove barriers and generate innovative ways to ensure teams achieve project goals.
  • Must be an expert in negotiating with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
  • Must have experience in designing and implementing systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality with appropriate conventions, proper grammar and usage, and correct format requirements per ICH and other governing bodies.
  • Must have knowledge of all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.