Summary
Responsible for development implementation and maintenance of documents and/or business systems utilized for writing project support. Address and resolve issues within assigned therapeutic area(s). Interface with functional groups and writers to ensure timely completion of projects that are scientifically accurate and of high quality. Leads writing project efforts for team. Assists in selection supervision and project resourcing for writing team within assigned therapeutic area(s).
Responsibilities
Serves as Medical Writing Lead on more complex writing assignments implementing all activities related to the preparation and compilation of data and information into assigned writing projects.
Leads writing project efforts for team. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.
Assists in selection supervision and project resourcing for writing support within assigned therapeutic area(s).
Accountable for meeting the main objectives of clinical writing projects in therapeutic area(s) within established timelines budgets and with an appropriate quality level.
Provides project management for writing projects for multiple compounds and/or indications within assigned therapeutic area ensuring accuracy and adherence to timelines and processes
Works directly with team members to develop/implement timelines to meet desired project completion dates. Coordinates activities and communication with functional areas on writing projects. Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and scientific knowledge.
Proficiently learns and applies therapeutic area and product knowledge to scientific projects. Develops expert knowledge of regulations requirements policies and guidelines that apply to the preparation and production of writing projects and ensures staff understands complies and applies them to work products.
Ability to form maintain and lead productive cross-functional working teams including addressing issues that arise. Collaborative teamwork and leadership track record. Implements systems or solutions to enhance efficiency eliminate redundancy reduce expenditure and guarantee quality.
Oversees writing projects to ensure timely completion. Must resolve conflicts remove barriers and generate innovative ways to ensure teams achieve project goals.
Knowledgeable about the product/disease state and is an expert on medical writing. Continually trains/be compliant with all current industry requirements as they relate to assigned writing projects.
Qualifications :
Bachelors degree in English or Communications with relevant science expertise or Bachelors degree in Life Science with relevant writing expertise. Advanced degree in scientific field and/or professional certification/credentials preferred.
3 years relevant industry experience required; 5 years relevant experience in medical writing in the healthcare industry or academia required or in a related area such as quality regulatory publications clinical research or product support/R&D; 4 years experience in experimental design and clinical/preclinical data interpretation required; and 2 years in a project management role required.
Form maintain and lead productive cross-functional working teams including addressing issues that arise. Collaborative teamwork and leadership track record.
Working knowledge of applicable regulations and legislation.
Excellent business communication skills with aptitude for summarization as well as detail orientation.
Experience developing and delivering presentations to senior management.
Ability to understand and interpret medical data and create and develop strategic messaging required.
Knowledge of product therapeutic area preferred.
Microsoft Office and Internet navigation proficiencies essential. Working knowledge of statistical concepts and techniques required. Working knowledge of other business-related information technology.
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).
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 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:
Yes
Employment Type :
Full-time
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