Senior Specialist, Pharmaceutical Labeling Artwork

Job Description

The role of Senior Specialist, under the supervision of the US Market Artwork Team Lead, as a Labeling Artwork Lead is responsible for:

• Develop and revise artwork for US market for NDA/BLA submissions/supplements to FDA, production needs and human factors testing.

• Revise artwork for WHO submission and production.

• Initiate artwork projects in Artwork Management System and review and approve composed artwork.

• Coordinate the end-to-end US artwork development process for labeling and work cross-functionally with CMC and manufacturing sites to implement new or revised labeling.

• Support Artwork in product launches and unique or complex artwork execution.

• Work with a cross-functional team to enable artwork reviews and drive consensus, ensuring all appropriate stakeholders are aligned.

• Participate in creation of FDA response documents and meetings when necessary.

• Provide labeling components for NDA/BLA Annual Reports

• Participate in special project assignments related to artwork and related labeling when needed.

Education:

• Bachelor’s Degree is required

Required Experience and Skills:

• Minimum of 4 years pharmaceutical/biological labeling artwork experience or relevant professional experience. 

• Regulatory submission and approval experience

• Expertise in labeling regulations, and artwork processes

• Detail oriented, well organized, and excellent planning and prioritization skills. 

• Experience leading teams, driving consensus and results. 

• Excellent communication, interpersonal and collaboration skills.

Preferred Experience and Skills:

• Experience and knowledge of supply chain

• Medical Device & Combination Product Labeling

• Adobe Creative Suite and Microsoft Office

• Perigord and Docu-Proof

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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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. 

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Relocation:

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