Director, Strategic Medical Writing (Remote)
Director, Strategic Medical Writing (Remote)
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Salary Not Disclosed
1 Vacancy
Job Description
The Director Strategic Medical Writing directs centralized clinical writing function across therapeutic areas and/or multiple drug programs within Development ensuring successful preparation of high quality submission-ready documents and effective management of the clinical writing process in accordance with clinical and regulatory timelines. Oversees business systems that support clinical regulatory document creation. Provides leadership in regulatory document development and submission strategy and expertise in project management for documents for multiple compounds therapeutic areas (both large and small) and regulatory submissions. Ensures accurate and timely completion review and delivery of information for regulatory submissions. Determines resource needs prepares tactical plans to ensure adequate resourcing and manages internal and outsourced personnel. Determines outsourcing strategy and ensures expectations with vendors by the Senior Managers Medical Writing responsible for strategy implementation.
Responsibilities:
- Provides strategic leadership and direction for clinical and regulatory writing projects for one large or multiple smaller compounds within a therapeutic area for the creation and revision of clinical and regulatory documents within budget with quality and in accordance with timelines with oversight of both internal and external staff. Ensures clinical and regulatory development strategy are reflected in the documents.
- Directly leads at least 1 people leader and multiple individual contributors. located in geographically disbursed locations. Ensures effective management of external business partners such as CROs who are employed to deliver clinical documents according to established standards and processes.
- Participates in continual improvement across Strategic Medical Writing practices processes and performance. Leads execution of cross-functional initiatives
- Effectively utilizes project management tools/techniques to drive multiple projects; responsible for overall project management for several projects simultaneously.
- Works with cross-functional project teams to develop project objectives strategies corresponding timelines and milestones. Coordinates activities and communications on writing projects/submissions utilizing cross-functional skills/expertise and drug development knowledge. Holds team members to the project tasks/deliverables.
- Leads execution of cross-functional initiatives for Strategic Medical Writing.
- Collaborates with Strategic Medical Writing leaders to develop and maintain a workforce strategy plans for future talent needs support employee development addresses retention and succession planning.
- Collects appropriate metrics for assigned therapeutic area(s) as established by the Medical Writing organization
- Maintains expert knowledge of US and international regulations requirements and guidance associated with preparation of regulatory documentation and serves as a company-wide subject matter expert and liaison for other functions to ensure the application of highest industry standards. Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects. May serve as a consultant/liaison in partnerships with other companies.
- Maintains inspection readiness for assigned remit. Acts as the organizational representative in regulatory inspections and quality audits.
- This role offers the flexibility to work remotely
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications :
- A minimum of 10 years of bio-pharmaceutical industry experience in a global pharma biotech life science federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas. Minimum of 5 years of people management experience.
- Bachelors Degree or higher in a scientific discipline
- Broad knowledge and track record of successfully managing Medical Writing operations and can proactively prepare for all possible document obstacles.
- Demonstrated high level of competency in the AbbVie leadership behaviors (enter behaviors)
- Big picture and strategic thinker can formulate a vision of future state and lead the organization to build tactical plans to achieve this. Experience implementing large-scale change and process improvements relating to medical Medical Writing.
- Builds relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a highly matrixed organization.
- Excellent business and financial aptitude very analytical and uses data to drive the business and continuous improvements.
- Experience leading scaled global teams; managing and developing talent; leader of leaders who is able to engage inspire and align large diverse teams of seasoned professionals.
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
Employment Type
Remote
