Job Description

Job Description

The Senior Specialist - Clinical Data Disclosure & Transparency Medical Writer position will have primary responsibility for preparing trial disclosure documents in compliance with company policy and country laws and requirements.

Under the supervision of the Director of Clinical Data Disclosure & Transparency, the position is responsible to:

* Prepare scientifically valid draft and final narratives of clinical trial registration and results posting on www.ClinicalTrials.gov, EUDRA-CT and ENCEPP for studies of varying complexity and therapeutic designation;
* Perform and coordinate quality assurance reviews of documents, maintain audit trails of changes, resolve and respond to identified problems to ensure regulatory compliance.
* Collaborate reviews with appropriate staff and manage disclosure timelines;
* Prepare plain language (lay) summary trial results in 6-8th grade reading levels and provide input into the Health Literate Glossary;
* Assist external data sharing efforts and operations;
* Assist in document preparation to ensure compliance with transparency and privacy regulations to remove protected personal and confidential information;
* Provide input and feedback to Standard Operating Procedures and Working Instructions as appropriate.

Qualifications:

Bachelors degree in Life Sciences from an accredited four (4) year college; advanced degree preferred

Required Experience and Skills:

* Minimum 5 years experience working in a medical writing capacity, experience authoring clinical documents (i.e., Clinical Study Reports, Protocols, etc.), experience performing registration and result posting tasks preferred
* Clinical/regulatory process experience or in a pharmaceutical environment
* Knowledge of ICH and GCP guidelines required
* Health literacy writing competencies (6-8th grade reading levels)

Preferred Experience and Skills:

* A high degree of organization and ability to manage multiple projects at any given time.
* Attention to detail and committed to excellence in all aspects of their work.
* Ability to work under pressure, and to work independently and collaboratively in a team environment.
* Excellent communication and interpersonal skills.
* The ability to maintain a positive attitude under pressure.

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.

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Flex Time, Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2
Requisition ID:R94762