portal resources jobs companies m merck sharp & dohme senior informed consent writer

Senior Informed Consent Writer 🔥


Job Description

The Senior Medical Writer – Informed Consent (SMW IC) is responsible for development and management of medical writing informed consent forms that support the clinical regulatory writing portfolio and our ability to conduct clinical trials. The SMW IC is capable of working independently and as part of a team to achieve goals. In this role the SMW IC:

Is recognized as a significant scientific contributor and subject matter expert in preparation of informed consent documentation.

Applies in-depth knowledge of informed consent medical writing, bioethics and health literacy to support pipeline projects. Represents functional area in cross-functional team (internally).

Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific and medical requirements, using own judgment, prior work experience, and broad appreciation of effects on other disciplines.

Manages informed consent projects including the design, planning, and preparation of informed consent documentation in support of trial development. Works collaboratively to achieve results.

Solves complex problems associated with informed consent medical writing scope of work and seeks advice from senior members of the department when appropriate. Provides options and negotiates informed consent text in order to produce informed consent forms that meet the needs of the client.

Participates in medical writing process improvements and initiatives.

Minimum required education:
Degree in the Life Sciences, Medical Communications or Public Health (post-graduate degree strongly preferred)

Bachelor’s degree with 4+ years; or Masters-level with 2+ years; or PhD with 1+ years of relevant career experience.

Required experience and skills:
5+ years of relevant medical writing or clinical trial experience

Demonstrated experience of translating scientific and medical material for a lay audience, and strong knowledge of health literacy principles

Knowledge of regulatory guidance governing informed consent

Ability to manage and negotiate documentation projects with project teams

Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management

Excellent oral (including presentation) and written communication

Excellent project management skills.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

MW20

MRLGCTO

EligibleforERP

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

Residents of Colorado

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

Current Employees

Current Contingent Workers

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.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:
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:
Hybrid, Remote Work

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
Number of Openings:
1

Requisition ID: R205758

Let us send you new openings similar to Senior Informed Consent Writer straight to your Inbox. Weekly or Daily. 7-day free trial 💌

The ability to work remotely increases employee happiness by 20 percent.