Specialist, Document Disclosure

Merck; Rahway (NJ); Hybrid; USD 85,000 - 135,000; Full time

Job summary

A leading pharmaceutical company seeks a Specialist in Document Disclosure to ensure compliance with transparency and privacy regulations. The role includes document review, quality checks, and collaboration with various teams on clinical documentation. Candidates should hold a Bachelor's degree in Life Sciences and have at least three years of relevant experience.

Benefits

Comprehensive benefits package

401(k) retirement plan

Paid holidays and vacation

Qualifications

• Three years of pharmaceutical industry and/or clinical research experience.
• Knowledgeable in EMA and/or Health Canada publication requirements.
• Experience in writing drug and device submission documents.

Responsibilities

• Review and prepare documents to ensure personal protected information is removed.
• Facilitate collaborative reviews with authors and product teams.
• Execute quality checks of documents and manage disclosure timelines.

Skills

Attention to detail

Communication

Project Management

Education

Bachelor’s degree in Life Sciences or a related discipline

Tools

Electronic Document Management system

Job description

Job Description

The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers.

The Specialist provides support to document disclosure group and holds primary responsibility for ensuring the company's compliance with transparency and privacy regulations by collaborating with product development teams to review documents with protected information and redact accordingly.

The responsibilities of the Specialist in Document Disclosure are:

• Reviewing and preparing documents to ensure personal protected information is removed.

• Facilitating collaborative review with contributing authors and product development team to identify commercially confidential information in documents.

• Executing quality checks of documents including the completion of associated justification.

• Managing disclosure timelines and participating in submission planning management team meetings.

• Monitoring and escalating potential incidences in release of protected information.

• Providing input and feedback to the Standard Operating Procedures and Working Instructions for the preparation of documents for public release.

• Assist other disclosure efforts and operations (e.g. external data sharing, clinical trial application activities).

Qualifications

Bachelor’s degree in Life Sciences or a related discipline

Required Experience and Skills

• Three (3) years of pharmaceutical industry and/or clinical research experience.

• Proficiency in the use of a Doc base system or similar Electronic Document Management system.

• Experience writing or general understanding of the content of drug and/or device study submission documents.

• Knowledgeable in European Medicines Agency's (EMA) and/or Health Canada publication of clinical information requirements.

Preferred Experience and Skills

• Highly organized and able to manage multiple projects at any given time.

• Attention to detail and dedicated to excellence in all aspects of their work.

• Ability to work under pressure, while maintaining a positive attitude

• Excellent communication and stakeholder management skills.

• Able to work independently and collaboratively in a team environment.

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:

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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.

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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

$85,600.00 - $134,800.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Preferred Skills:

Job Posting End Date:

07/2/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R347540