ASSISTANT DIRECTOR MEDICAL WRITING - REGULATORY
AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
Primary Job Function
The Assistant Director of Medical Writing is responsible for the development, implementation, and maintenance of business systems within the Global Project Teams (GPT) that provide regulatory document support to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective management of the clinical writing process. Provides leadership in the overall regulatory document strategy for one or more therapeutic areas, working in collaboration with the Regulatory team. Provides expertise in project management of multiple compounds and/or projects. Manages the development and implementation of regulatory documents in support of overall regulatory strategies for multiple studies and/or compounds within one large or two or more small therapeutic areas. Interfaces with external groups (eg, PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions. Determines clinical writing resource needs for assigned therapeutic area(s) and manages both internal and outsourced personnel. The Assistant Director of Medical Writing is accountable for meeting the main objectives of the assigned therapeutic area(s) within established timelines and budgets, to the highest level of quality.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
* Supports scientific and marketing objectives for multiple compounds within one large or two or more small therapeutic areas in development through coordination, preparation, and approval of scientific documents within the Global Project Team. Projects include study reports, FDA briefing documents, IND annual reports, Investigator’s Brochures, CTD/NDA documents.
* Provides oversight and project management of clinical writing projects for multiple compounds and indications within assigned therapeutic area(s), within budget and in accordance with clinical and regulatory timelines.
* Works with Global Project Teams and functional areas to develop project objectives and strategies and corresponding timelines and milestones. Effectively utilizes project management tools and techniques to drive multiple projects; responsible for overall project management for several projects simultaneously.
* Builds cross-functional relationships and leads team meetings to address specific projects and hold team members to the project tasks and deliverables.
* Implements established standards, as appropriate, for business purposes and ensures they are consistently applied.
* Executes effective delegation, oversight and mentoring of permanent Abbott medical writers and contract writers working on projects for the therapeutic area(s) or multiple project teams.
* Works directly with Global Project Heads, Assistant Directors, and Clinical Project Managers to develop/implement timelines to meet desired project completion dates.
* Coordinates activities and communications with functional areas such as Statistics, Regulatory, eSubmissions, Pharmacokinetics, Medical Directors/Safety Team on writing projects/submissions.
* Designs and implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
* Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge.
* 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.
* Assists in selection and supervision of agencies, freelance consultants, or other vendors.
* Ensures department understands/complies with appropriate conventions, proper grammar and usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
* Develops expert knowledge of international regulations, requirements, and guidelines that apply to the preparation and production of submission-ready clinical documents.
* Collects appropriate metrics for assigned therapeutic area(s), as established by the Medical Writing organization, that ensures a high level of internal writing performance as well as adherence to pharma industry standards (i.e. speed, volume, quality, complexity).
* Determines resource needs within assigned therapeutic area(s) and manages associated budgets. Prioritizes resources to ensure efficient and timely completion of writing projects for the GPT.
Position Accountability / Scope
* Accountable for meeting the main objectives of clinical writing projects in one large or several smaller therapeutic area(s) within established timelines, budgets, and with an appropriate quality level.
* Held accountable for driving writing projects to timely completion. Must resolve conflicts, remove barriers, generate innovative ways to ensure teams achieve project goals.
* Responsible for effective communication among 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.).
* Manages the development of direct reports, including creation of performance assessments, goals, and growth plans.
* Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
* Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
* 8 yrs relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/R&D.
* Minimum 3 yrs of project management experience, preferably with regulatory document project management and 3 or more yrs writing/editing and reviewing experience, preferably in the healthcare industry.
* Minimum 5 yrs of management/supervisory experience including employee development.
* Knowledge and experience with CTD content templates.
* Expert knowledge of international regulations, requirements and guidance associated with document preparation and submissions.
* Working knowledge of current electronic document management systems and information technology.
* Proven track record of managing internal and external resources.
* Track record of successful completion of significant projects using project management tools and processes. On time deliver of quality products.
* Experience in human and financial resource management.
* Collaborative teamwork and leadership track record. Excellent business communication skills with aptitude for summarization as well as detail orientation.
Minimum Experience / Training Required
Requires problem solving abilities at both strategic and operation levels.
* Recognizes potential scheduling and resource conflicts for project and provides recommendations to resolve.
* Identifies issues impacting team alignment and implements resolutions to resolve team discord.
* Challenges and make recommendations to the GPT to achieve best possible timeline and resource utilization.
* Identifies and anticipate potential department problems impacting ability to meet business goals, develops and implements methods of improvement and resolution.
* Actively participates in process improvement initiatives, both within the department and division-wide.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time