The Associate Director of Regulatory Strategic Writing (RSW) is responsible for leading a writing team corresponding to a Therapeutic Area (TA) (eg, Oncology) or for leading an individual writing team dedicated to a program within a TA. The RSW Associate Director is responsible for supervising full time staff and external resources in their efforts to support critical regulatory documents (e.g. briefing books) and responses to health authority information requests. In partnership with the Global Regulatory Product Team (GRPT), the RSW Associate Director and his or her direct reports drive the compilation and preparation of critical global strategic regulatory documents articulating the scientific justification of company positions and relevant knowledge for submission to global health authorities. The Associate Director role may report to a Director within RSW or to the Head of RSW.
- In cooperation with Global and Area Regulatory Leads and functional area contributors, coordinate any or all programs and projects necessary to support TA interactions with healthcare authorities. This includes acting as the primary representative for RSW with respect to GRPTs.
- Provide regulatory writing expertise, leadership, project management support, supervision of RSW resources, and strategic input on document preparation and submission for one or more compounds and/or projects within a TA. Ensures that documents authored by RSW are of high quality and are submission ready prior to submission to health authorities.
- Hire, on-board, train, and supervise full-time staff and external resources supporting RSW programs and initiatives. This includes conducting performance reviews and talent management activities for the team members when acting as the TA Lead, or contributing feedback to the TA Lead in support of talent management. Manage regulatory writing project assignments across the Associate Director’s TA team.
- Support the Head and/or a Director of RSW in authoring and maintaining RSW document processes (eg, SOPs, work practices, job aides, templates and other supportive documentation, etc.) as needed, to align with department and organizational goals, to stay compliant with corporate guidelines, and to leverage current IT platforms efficiently. Coordinates team contributions to the RSW SharePoint team site.
- Participates in or leads initiatives pertinent to the RSW team. Participates in leadership team meetings to provide RSW and management insight, as needed.
- Serve as the RSW lead on regulatory document support requests. This includes supervision of all RSW contributors as well as providing writing support and drafting of the document when necessary. When required, communicate progress and track required deliverables and timelines/milestones to team members. Interface with internal and external groups to ensure accurate and timely completion/delivery of information to be submitted.
- Responsible for talent management oversight and performance reviews for full time employees within the assigned TA. Supervises training and ensures assignments are completed in a timely manner.
- Maintain the RSW Book of Work and forecast overall global project/departmental workload for assigned TA.
- Network with other departments within AbbVie that perform similar activities to optimize writing processes within AbbVie and Regulatory Affairs. Build strategic partnerships and develop a strong knowledge of key resources available within the organization. Collaborate effectively with management and Subject Matter Experts to design optimal cross-functional solutions.
- A Bachelor's degree is required. A relevant advanced degree (e.g. MS, Pharm D, PhD, MD) is preferred and may substitute for years of experience. . American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
- Minimum of 5 years of relevant industry experience required in medical/regulatory writing in the healthcare industry or academia or in a related area such as quality, clinical research, or product support or research and development; 3+ years in a leadership role with strong management skills; 2+ years of supervisory experience.
- Experience with building teams and providing coaching, mentoring, and training as appropriate to drive world-class performance preferred.
- Demonstrated experience in collaborating cross functionally. Proactive at resolving problems; needs little guidance on forging strategy and executing on that strategy. Able to increase the level of skill of team over time. Strong written and verbal communication skills, including strong negotiation skills.
- Experience in Regulatory Affairs either via industry or education; knowledgeable of US and international regulations, requirements and guidance associated with clinical research and drug development. Experience writing regulatory documents in multiple therapeutic areas preferred, and ability to assimilate and interpret and translate information for appropriate audience.
- Working knowledge of current electronic document management systems and information technology; knowledge of and experience with Common Technical Document content templates. Excellent working knowledge of software programs in a Windows environment.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 5 % of the Time
Job Type: Experienced