Job Description

The Health Literacy Specialist role in the Medical Writing Disclosure (MWD) department will be primarily responsible for preparing Plain Language Summaries (PLS), including the Protocol PLS and Results PLS, of clinical studies per our company's processes and standards to ensure compliance with internal policy, regulatory requirements, and health literacy principles.

Under the supervision of the MWD Health Literacy Projects Lead, the Specialist will be responsible for :

Authoring accurate, clearand health literate clinical trial PLS for posting on EU Clinical Trial Information System (EU CTIS) and other public registries where required by law or company commitment. These summarieswill be for studies of varying complexity across therapeutic areas.

Developing PLS based on source documents (e.g., Protocols, Clinical Study Reports, Tables, Listings, and Figures), negotiating content with internal and external reviewers to ensure it meets regulatory requirements while leading the summary through review and final approval

Collaborating with clinical teams, requesting necessary data and information, and negotiating language to ensure the PLSisaccurate, health literate, and non-promotional

Responding to clinical and legal review comments on PLS; amending the summaries as required and facilitating approval within the required timelines for public posting

Collaborating with the Health Literacy team in the development and maintenance of plain language structured content and graphic libraries

Ensuring Project Leads and management are informed of problems or unresolved issues that could affect compliance timelines or work quality

Buildingexpertise in the regulations associated with clinical trial PLS and adapting to the changing regulatory environment as needed

Education :

Bachelor’s degree preferably in a Life Sciences related discipline

Required Experience and skills :

One year experience in plain language writingsuch as patient or public facing materials, PLS, or other health literate clinical research materials

Experience communicating medical and scientific information with patients or the public

Effective Project Management skills with a high degree of organization and the ability to manage simultaneous projects under tight timelines

Demonstrated team skills, professional values, and personal skills necessary for effective teamwork; able to work in cross-functional environment; able to pivot quickly due to changes in priorities and assignments

Excellent communication and interpersonal skills (both oral and written) in order to interact clearly, effectively, and tactfully with stakeholders

Strongattention to detail, analytical/logical thinking skills; able to critically evaluate data

Ability to work independently and collaboratively in a team environment

Preferred skills :

Understanding of the principles of clinical research, clinical trial design, fundamental statistics, and safety data reporting

Experience in translating scientific content into easy-to-understand textusing health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities

Background in medical writing, authoring ICH clinical/regulatory documents (i.e., Informed Consents, Clinical Study Reports, Protocols, etc.)

Knowledge of International Council for Harmonizationand Good Clinical Practice guidelines

Candidates selected for an interview may be asked to provide writing samples

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 separation package, 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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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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

Learn more about your rights, including under California, Colorado and other US State Acts

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, generally Tuesday, Wednesday and either Monday or 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:

$83,100.00 - $130,900.00

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 .

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/19/2024

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

Job Posting End Date: 09/19/2024

A job posting is effective until 11:59:59PM on the day BEFORE the 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: R310462