Associate Director, Submissions Content Source Management Business Operations Lead (Hybrid role - onsite 3 days per week required)

THIS IS A HYBRID ROLE - REQUIREMENT TO WORK WITHIN A COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK)

The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply common principles to the cross-functional processes to maintain minimum system complexity while providing high value efficiencies. The Lead will collaborate with cross-functional stakeholders on a daily basis, monitor and evaluate current state, facilitate change planning and drive implementation.

Specific responsibilities of this position include:

• Function as Business System Owner (BSO) of the current Documentum-based global submission content management solution

• Co-lead the implementation of the next generation Veeva Vault RIM-based global content source management solution and function as BSO

• Lead the Change Management and Business Process activities to drive adoption of the new solution

• Support daily operations of the current Documentum-based submission content source management system and the cross-functional user base

• Own the business requirements as the BSO and make decisions on requirements and design topics

• Support functional areas in identification and review of process questions and issues related to submission content management, quality and standards compliance

• Engage across functional areas to identify opportunities for improvement; support the execution of improvement initiatives including business process design, coordination of IT activities, change management and training

• Partner with QA and Standards to ensure the content management solution and its associated templates and interfaces adhere to Our Company and Health Authority standards and meet business process requirements

• Develop and evaluate metrics as part of a data quality monitoring plan to determine where process improvements or training may be required

• Participate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for account creation and pre-approved change management   

• Provide guidance and leadership for M&A activities as it relates to submission content source management; partner with IT and cross-functional SMEs on migration projects

Education:

• Bachelor’s degree with a minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a master’s degree and a minimum of 8 years of industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment

Required:

• Experience with the implementation and operations of a modern Veeva RIM Vault A MUST!

• Knowledge of the regulatory submission processes, systems, and business requirements

• Experience working closely with IT organizations in the design, development, and implementation of technical systems and tools

• Knowledge of system development lifecycle and data administration concepts

• Demonstrated experience assessing and enabling process change, especially with cross-functional teams in customer (client) facing roles

• Ability to lead and influence others outside of a direct reporting relationship

• Broad organizational awareness and knowledge of touch points/interdependencies

• Demonstrated Change Management experience, including developing business processes and training documentation

• Process Management Knowledge (e.g., Green Belt)

• Project Management Skills

• Demonstrated capabilities managing and mentoring staff

• Strong communication skills (written and verbal), organizational skills and attention to detail

Preferred:

• Experience with other content management systems such as Documentum

• Advanced knowledge and capabilities applying technology within a business environment

• Sigma Black Belt, Change Management Certification, PMI Certification.

Required Skills:

Adaptability, Adaptability, Business Management, Business Process Consulting, Business Processes, Business Process Improvements, Business Systems, Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review, Employee Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$126,500.00 - $199,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.