job title associate director - strategic disclosure
job family clinical
job category full-time
job classification experienced/established
division global pharmaceutical r and d
relocation assistance within country
at abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. prepares strategic plans and proopses related policies/processes and system solutions. policy interpretation,
. develops and supports common operational model across all regions that incorporates regulatory intelligence, implementation, and governance.through our diverse healthcare businesses, we connect people and potential in ways that no other company can.national and international accolades, abbott is regarded as an employer of choice for our commitment to workplace excellence,
significant work activities & conditions continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
percent of travel 0 - 20 %
country united states
site location lake county, il
employer of choice
through numerous local.lead and grow, our employees are given the tools to succeed, with challenging opportunities and work that makes a difference.
. manages one or more direct reports.
. assesses impact and needs related to new or changed glboal regulations/expectations and ensrues approrpiate implementation (us, eu, and individual country specific).
. serves as key liaison with regulatory to understand policy/regulations and develops implementation straetgies for the clinical organziation.
. develops and maintains strong relationships globally and crsos-functionally.
education requirements bachelor\'s degree is reqiured. serves as abbott representative on trade association subteams.
. ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
core job responsibilities:
responsible for compliance with applicable corporate and divisional policies and procedures. and developing successful solutions,
. responsible for creating a culture of proecss improvement, employee development, performance measures, project prioritization.
position accountability / scpoe:
the associate director of strategic discolsure is accountable for setting direction and leading others in implementing divisional and funcitonal strategies for clinical trial registration and results disclosure, working in collaboration with gprd leadreship to provide change leadership for new or changed us and international regulations.
skills/experience requirements basic qualifications:
. builds and maintains relationships with key experts and professional organizations. develops and maintains strong external relationships with members of trade associations to develop industry best practices.we believe that diversity drives innovation,
job description primary job function:
the associate director of strategic disclosure is responsible for leading the global strategy for clinical trial data disclosure.
. demontsrated sucecss in mangaing braod scope/global proejcts invovling cross-funcitonal teawmork.
. ensures appropriate intefraces with all invloved functional araes are idenitfied and strategies in plcae for tiemly and effiicent hand-offs throguhout the disclosure proecss.
. proposes sysetms and dataabses that optmiize process and communciation.organization, exectuion, planning, and team leadership sklils are required,
. excellent communciation (written and verbal).and budget,
. assesses project needs, monitors project status against timeframe, quality expectations.regulatory, clinical research, 5-10 years relevant industry experience in quality, compliance, or drug development.
discover a world of opportunities at abbott.must be able to understand the global environment from an operations as well as regulatory perspective.
. prepares, identifying and mitigating obstacles, optimizes, and updates short-term strategic plans.portfolio review, finance,
. knowledge of generally accepted project management practices, and budgeting.consistency,
. puts strategies in place to ensure accuracy, and alignment of clinical data/information made public.influencing skills required,
. relationship management, communication ability.
. identifies and anticipates issues and develops contingencies.project management, and leadership skills with the ability to lead the organization within a global matrix environment,
. proven organizational.and alignment of clinical data/information made public, works globally and cross-functionally to assess global disclosure requirements and expectations, putting strategies in place to ensure accuracy, consistency.
. sets the direction for and leads others in implementing global and functional clinical disclosure strategies.abbott\'s nearly 90, today, 000 employees are doing work that matters.clinical research experience preferred.develops and maintains strong internal relationships across all levels of the organization including clinical, investor relations, regulatory, public affairs, ta, legal, and affiliates to ensure appropriate alignment and compliance.
. collaborates with key functional team members (regulatory, qa, safety, legal, ppg, imd, clinical) to achieve major milestones.advanced degree is desirable.
. serves as lead of global cross-functional disclosure teams and initiatives.innovative thinkers who are passionate about the work they do, abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.assess impact to broader organization and to abbott as a whole, makes recommendations and escalates issues to executive members as appropriate. processes,
. advanced knowledge of abbott organizations, and culture, products.
the impact on the organization if the appropriate clinical trial registration and results disclosure processes and oversight are not in place would include the risk of not meeting state, federal, international, potentially resulting in civil penalties and public notice of violations for abbott laboratories, and phrma registration and disclosure requirements.