Manager, Process and Document Management-6674140611
Description
Janssen Scientific Affairs, L.L.C.is recruiting for a Manager, Process and Document Management to be located in either Raritan, NJ, Titusville, NJ or Horsham, PA.
Janssen Scientific Affairs, L.L.C. is dedicated to providing medical information and consultative support to a number of J&J's pharmaceutical companies. The company's mission is to create the pre-eminent model of scientific excellence in the promotion of public health.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Process and Document Management has primary responsibility for managing the procedural documents lifecycle (i.e., policies, standard operating procedures, work instructions, manual, guidelines, and forms) for US Janssen Scientific Affairs (JSA) organization. This includes procedural document development, coordination of periodic reviews, revision and obsolescence of documents, impact assessment process management; and contribution of training contents to ensure consistency with the procedural documents.
This position will also be responsible for ensuring that JSA procedural documents are consistent with J&J global processes (including J&J Enterprise Standards, J&J Guidance Documents, Healthcare Compliance, and Cross-Pharma documents).
Collaborates with stakeholders / process owners to identify working teams and develop procedural workflows.
Manages the review & approval cycle to ensure procedural documents meet established development timelines and facilitates periodic review per procedural lifecycle requirements.
Develops timely communications for all newly effective procedural documents, revised procedural documents and obsolescence of procedural documents to JSA.
Liaise with other J&J organizations when JSA procedural documents have interdependencies with those groups.
Ensures alignment of regulatory requirements and J&J standards, policies and procedures across JSA procedural documents.
Manages procedural documents in electronic document management system.
Maintains procedural document index, common glossary, templates. Reviews findings, and monitors compliance trends related to procedural documents and communicates compliance issues / concerns to department manager. Manages the impact assessment review and documentation process for J&J documents such as the enterprise standards, pharma sector standards, and cross pharma).
Assist JSA organizations to process map their procedures documents and identify improvement opportunities.
Represents JSA businesses on global and regional committees/ work streams.
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Qualifications
A minimum of a Bachelors degree required; Advanced degree preferred.
Six plus (6+) years experience in the Pharmaceutical industry is required.
Strong working knowledge and experience with document management and/or technical writing, process mapping, and project management, documentum highly preferred.
Understanding of/working experience in/collaboration with: call center, safety, research trials or clinical related processes are required.
Experience working within regulated areas of Pharma, or other similar regulated environment (e.g.,Medical Device), with an in depth knowledge of regulations and compliance requirements, and the processes and procedures required to comply with them is required.
Experience working with Pharma document management systems is desired.
Competency working with Visio or other flowcharting system is highly preferred.
Experience as a SharePoint administrator is preferred.
An in depth knowledge and experience in the development process and management of procedural documents is required.
Must have excellent interpersonal, communication (verbal and written), presentation and organization skills. The position requires an energetic and enthusiastic person who is willing to work hard and capable of building a strong network and collaborate with various resources and internal and external partners.
The position will be based in Raritan, Titusville, or Horsham. There will be travel within J&J campus locations in NJ and PA (~25%) for meetings or training.
J2W: LI NA
Primary Location:North America-United States-New Jersey-Titusville
Other Locations:North America-United States-Pennsylvania-Spring House, North America-United States-Pennsylvania-Horsham, North America-United States-New Jersey-Raritan
Organization: Janssen Scientific Affairs, LLC (6120)
Relocation: Eligible No
Job Function: Regulatory Compliance
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