Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture.
We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Description: Provides leadership and technical expertise for controlled documentation and training programs, primarily for the North Brunswick (NOB) site and also assisting other Animal Health Global Innovation (AH GI) sites such as Ingelheim (LGC), Duluth (DUL), and Athens (ATH).
Establishes and oversees controlled documentation procedures and standards and leads a cross functional team of controlled documentation authors.
Represents AH GI in global teams and committees regarding documentation and training systems.
The position holder is the local document coordinator of controlled document management systems (e.g.
IDEA, Vault Quality), and of the learning management system (e.g.
Learning One Source) used for training management and compliance.
Additionally, the position holder acts as a backup to the local coordinator of the electronic document management system for submission relevant documents (e.g.
BIRDS).
The position holder is responsible to establish and maintain various other information systems such as: Teams, SharePoint, websites, network shares, etc.
Also supports paper-based documentation processes.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers.
Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success.
We realize that our strength and competitive advantage lie with our people.
We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance.
Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
Duties & Responsibilities: Establish and oversee controlled documentation procedures and standards.
Lead cross functional team to create and improve local & functional standard operating procedures, policies, guidelines, manuals, and work instructions.
Represents AH GI in global teams and committees regarding documentation and training systems.
Local coordinator of electronic document management systems for quality documents (e.g.
SOPs, guidelines, forms) and other documents with record retention needs (e.g.
internal project documents, computerized system validations).
Create and maintain document templates.
Coordinate with global team regarding standardized practices and support models.
Create and manage workflows for new or revised documents, with supporting metadata as appropriate.
Generate reports and metrics.
Act as a local expert, provide training and support as needed.
Ensure compliance with local and global procedures and regulatory requirements.
Provide backup coordination support to other AH GI sites as needed.
Local training coordinator, assisting local & functional management to define roles and associated training curricula.
Local coordinator of the learning management system, to support training requirements management and compliance.
Create and maintain training item records, with assignment to users and roles corresponding to locally defined training requirements.
Where applicable, ensure manual entry of training completions and preserve associated documentation.
Coordinate with global team regarding standardized practices and support models.
Implement new capabilities e.g.
learning assessments, computer based training, on-the-job training, etc.
Generate reports and metrics.
Act as a local expert, provide training and support as needed.
Ensure compliance with local and global procedures and regulatory requirements.
Provide backup coordination support to other AH GI sites as needed.
Backup to the local coordinator of the electronic document management system for submission relevant documents (e.g.
study protocols, study reports, product development reports).
Create and manage workflows for new or revised documents, with supporting metadata as appropriate.
Order equipment logbooks and issue/replace as requested, based on established templates.
Track issued logbooks and issue replacements when due.
Maintain logbook templates.
Submit completed logbooks to the NOB archive.
Contribute to organization and maintenance of additional information systems used by Computer Systems and Equipment, e.g.
Sharerooms, websites, network drives.
Requirements: BS degree from an accredited institution in Chemistry, Computer Science, or a related field, with four (4) years of experience in pharmaceutical research and development or relevant field; Or MS degree from an accredited institution in Chemistry, Computer Science, or a related field, with two (2) years of experience in pharmaceutical research and development or relevant field.
Computer systems experience.
Ideally, experience with computerized systems for document management and/or training management.
Ideally, strong knowledge of pharmaceutical research and development processes and techniques, with an understanding of the required documentation.
Preferred to have strong knowledge of regulatory requirements.
Excellent skills in interpersonal communication, organization, technical writing, customer focus, integrity, and teamwork.
Attention to detail, able to follow complex procedures precisely.
Achievement focused with appropriate alignment for regulatory and quality requirements.
Transparent in communication of failures.
Positive attitude (“can do”) and willingness to take risks.
RSRBI 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.
This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation.
Click here for more information on the vaccine mandate and COVID-19.
Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients.
We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals.
As a family owned company we focus on long term performance.
We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.
Learning and development for all employees is key because your growth is our growth.
Want 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 culture.
We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
All qualified applicants will receive consideration for employment without regard to a persons 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.
LI-JB1 Organization: US-Boehringer Ingelheim Animal Health Title: Associate Manager, Documentation & Training Location: Americas-US-NJ-North Brunswick Requisition ID: 223708