Merck Lead Content Steward in Rahway, New Jersey

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Position Description:

Seeking an individual with strong understanding of clinical study document content and the interrelationships of that content to develop structured content mapping for reuse. The individual will be responsible for decomposing clinical content and linking content for action (ie, by assigning relevant metadata and reuse policies). Merck has embarked on an effort within clinical to connect their clinical content for standardization to ensure the quality/consistency of their clinical documentation. The individual must fully understand the clinical development process, content library and governance concepts, as well as technology concepts and analytics.

The position is in the Clinical Development Medical Writing Department within the Clinical Content and Standards function. The activities will focus on content information and design, structured authoring, and acting as a steward for the structured authoring tool.

The Lead Content Steward is responsible for leading, providing strategic input, and making scientific contributions in the development, implementation, and management of structured content authoring processes and standards (e.g., structured content, SDTM, TransCelerate, CDISC, ICH, governance, therapeutic libraries, tool requirements) to support all clinical regulatory writing portfolios. This person is expected to work independently to achieve goals and to exercise foresight to identify potential opportunities to enhance the business through the use of structured content.

Medical Writing writes various documents (eg Investigator Brochures, Clinical Study Protocols, and Clinical Study Reports) to start clinical studies, get our products approved, and maintain our products on the market. As a result, the individual will have an opportunity to learn about clinical development of pharmaceutical products and the regulations that govern how a product moves from research in humans to the market. The person should present as highly motivated with interests in medicine, pharmacology/pharmacy, or chemistry sciences, biological sciences or data/information management, as well as interests in writing and communicating medicine and science.

In this role the Lead Content Steward will:

  • Have an advanced understanding of content standards

  • Develop policies concerning Structured Content and Structured Content Authoring expectations with external understanding

  • Use advanced knowledge of end-to-end data & information flow

  • Lead/participate in cross-functional content design and governance teams to manage the definition, review, harmonization, management, use, and retirement of global and study-level clinical content standards metadata based upon industry standards

  • Build talent across the department; mentor project teams

  • Actively participate in and monitor external industry standards activities (e.g., TransCelerate)

  • Lead development and maintenance of Merck clinical study document content design and TA library standards

  • Provide expertise regarding specified content/domain area(s) standards and industry data standards, including their associated regulatory requirements, and business process knowledge to data standards development, implementation, and maintenance activities

  • Define and maintain content design, therapeutic libraries, and template content adopted at Merck, in collaboration with standards development teams (e.g., Data Collection, CT, SDTM, ADaM, External Data)

  • Advise the clinical study project team members to address questions regarding standards use and governance

  • Lead large content development projects independently

  • Define and oversee implementation of a standards communication plan

  • Define, implement, track and report on standards implementation metrics

Required Core Competencies (strategic role - internal and external)

  • Document Writing - advanced knowledge of content (narrative, CSR, IB, CTD, and other reg docs)

  • Document management systems - working knowledge

  • Data Submission Regulatory Requirements - advanced knowledge

Soft Skills:

  • Meetings - lead and/or actively participate

  • Communication - advanced email skills with peers and managers, including upper management

  • Teams - lead or actively participate and influence internally, within division, and externally

  • People Manage - mentor others and teams

  • Task Manage - teams and others (functional management) work; manage and escalate issues

  • Quality - oversee the production of high-quality, timely documentation

  • Problem Solving - Solves complex problems involving ambiguous situations across departments and the need to develop new options to resolve

  • Team leader

  • Project management skills

  • Knowledge of management needs for different groups

  • Training and awareness of behavioral needs

  • Influencing and coordinating across organizations

Technology/Systems:

  • Understanding of the development and support process

Position Qualifications:

Education:

· BS degree with at least 7-years of pharmaceutical industry experience in one of the following areas: Clinical Development, Clinical Operations, Regulatory Submissions or Labeling (OR)

· MS degree or higher with at least 5 years pharmaceutical industry experience, in one of the following areas: Clinical Development, Clinical Operations, Regulatory Submissions or Labeling

Required Experience and Skills:

  • Proficiency in Office applications and Project Management. Project application of Agile methodology preferred. Programming knowledge preferred. High degree of organization and ability to manage multiple projects at the same time

  • Attention to detail and commitment to excellence in all aspects of work

  • Excellent communication and interpersonal skills and ability

  • Experience in structured content design and implementation

  • Experience with Structured Authoring tools

  • Knowledge of publishing process

  • Participation in governance

  • Ability to work in a team environment is required.

Preferred Experience and Skills:

  • Knowledge of Sharepoint

  • Ability to direct development teams

  • Developed Tool specification and tested tools

  • Experience in structured content design and implementation

  • Experience with Structured Authoring tools

  • GXP, GCP

  • The pharmaceutical development process and Touchpoints

  • Producing guidance and communication

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Clinical Research - Clin Ops

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-MA-Boston, NA-US-NJ-Rahway

Title: Lead Content Steward

Primary Location: NA-US-PA-Upper Gwynedd

Requisition ID: CLI007396