Job details
Job type full-time
Full job description
The associate director, scientific communications, external research provides strong subject matter expertise, operational oversight and process requirement support for the intake, evaluation, documentation, execution and follow-up of external research (er) activities, such as investigator initiated studies (iis) and external collaborative research (ecr)Uses their knowledge of external research and external connections to work with corporate and local clinical development and medical affairs (cdma), legal and other internal partners to process all er proposals, maximize and continuously improve operational efficiencies/customer satisfaction, provide training and ensure that compliant practices are adhered toUsing in depth knowledge of process and therapeutic area needs ensures er research interests and action plans are developed in accordance process and are consistent with therapeutic area needsLeads continuous improvement efforts, improvements to customer experience, and implementation of plans to meets internal and external customer needs and advance bi’s business.
As an employee of boehringer ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customersOur global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies` successWe realize that our strength and competitive advantage lie with our peopleWe support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balanceOur competitive compensation and benefit programs reflect boehringer ingelheim`s high regard for our employees.
Duties & responsibilities:
Process improvement
Responsible for executing and enhancing the external research (er) activities and capabilities in support of bipi’s cdma organizationDrives the cdma research agenda by applying a continuous improvement and customer experience mentality to refine processes and operations that support an evolving healthcare market.
Maintains expert knowledge and awareness of bi process and industry standards / government regulations that relate to both clinical trial conduct and industry support of investigator initiated studies.
Project management
Leads project management of er proposals from intake through to final archiving, setting appropriate expectations for both internal and external stakeholders regarding process steps through effective communicationCoordinates interactions between individuals involved in local er processingIdentifies systematic barriers that may affect program efficiency and proposes viable customer oriented solutionsAlso responsible for internal budget planning and forecasting and reporting for er activities.
Cdma support
Provides training, analysis, reporting and project management in support of cdma er activitiesPrepares, schedules, and leads local er review meetings to ensure efficient conduct in alignment with established processesAccountable for timely and accurate documentation and prompt action following reviews and committee-directed actions, including ensuring the accurate translation of scientific discussions into well-formulated communications to stakeholders.
Contributes to the development of metrics to monitor the timely processing of er proposalsAnalyzes and interprets data to support cdma and ta leadership decision making.
Provides process and compliance related training and guidance to cdma peers and other bi colleagues that interface with bi processes in support of er.
Ensures that all relevant bipi stakeholders (stakeholder relations, ta teams, fbm, etc.) are aware of external research activities in a timely manner at appropriate points in the process.
Er trial protocol
Leads and works cross functionally with global pharmacovigilance, cdma ta medical, and ra to review the trial protocol and ensure that appropriate safety monitoring, language and reporting, drug supply requirements, and protocol methods are included and clearly defined in the sponsor-investigator`s protocol for all er trialsReviews informed consent and other critical regulatory documentation to ensure alignment with bi`s expectations for erFollows trial conduct to ensure sponsor-investigators adhere to the terms of the trial agreement and the pharmacovigilance agreement as they relate to the safe use of bi`s drug substances in er trials.
Sponsor-investigators
In collaboration with the cdma ta personnel and the director, scientific communications, assists sponsor-investigators by providing responses to requests for medical/scientific information, in accordance with process defined methods, necessary for the investigator`s development of their proposalThis includes recognizing when additional support may be required from cross functional cdma ta personnel or other functions (e.g., clinical pharmacokinetics).
Requirements:
Bachelor’s degree from an accredited institution required, preferably in a related scientific or clinical discipline.
Ma/ms strongly preferred.
Five-plus (5+) years of industry experience, preferably including cross-functional experiences with marketing, commercial, finance, development and/ or medical affairs.
Five-plus (5+) years of experience with a clear record of successfully managing iis processes or equivalent type of medical process oversight preferred.
Professional certification in one more scientific communication functions (e.g., cmpp, chcp, ccra) preferred.
Experience with organization processes related to clinical trial operations, including documentation, drug supply, contracting, and payments.
In-depth knowledge of oig, fda and other relevant current government, industry, and organizational guidelines preferred.
Comprehensive understanding of processes, databases and systems, and other systems to support clinical trials activity.
In depth knowledge of current federal, industry, and organizational guidelines relevant to investigator initiated studies.
Demonstrated ability to work cross-functionally at a franchise and enterprise level and to keep various team members informed for progress at key points.
Ability to effectively work with stakeholders at all levels and across the enterprise.
Highly developed abilities in influence and working effectively through others.
Exhibits flexibility in working collaboratively across internal and external stakeholders.
Demonstrated customer- centric experience and track record of continuous improvement of processes / experience.
Demonstrated creative thinking and executional excellence/urgency.
Familiar with all applicable regulations, and industry standards as related to clinical research and pharmaceutical company interactions with health care providers.
Understanding of internal and external guidelines, including those related to publications, including the fda (21 cfr 213) and ich guidances relevant to er; iis best practice guidelines; phrma guidances and the oig; guidance for pharmaceutical manufacturers.
Ability to apply this knowledge to make judgment calls on appropriate external research process and strategy.
Knowledge of external research and external connections/awareness/benchmarks which results in continuous improvement of process, better meeting customer needs or better applicant/collaborator engagement with bi.
Eligibility requirements:
Must be legally authorized to work in the united states without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Compensation: this position offers a base salary typically between 106,600 and 133,300There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skillsThe position may be eligible for a role specific variable or performance based bonus and or other compensation elementsFor an overview of our benefits please click here.
Who we are: at boehringer ingelheim we create value through innovation with one clear goal: to improve the lives of patientsWe develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animalsAs a family owned company we focus on long term performanceWe are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive cultureLearning and development for all employees is key because your growth is our growthWant to learn more? visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive cultureWe embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communitiesAll qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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Job - medicine / regulatory affairs primary location - americas-us-ct-ridgefield organization - us-bi pharma/bi usa schedule - full-time
