Chenega Corporation Medical Writer (Part-time) - FDA/OSE in Silver Spring, Maryland

CHENEGA PROFESSIONAL & TECHNICAL SERVICES, LLC

Company Job Title:

Medical Writer-OSE-CPTS

Chenega Job Title:

Subj. Matter Spec VI, COMM

Clearance:

NACI

Location:

Silver Spring, MD

Reports To:

Program Manager

FLSA Status:

Regular, Part-Time, Hourly, Non-Exempt

Prepared Date:

9-25-2018

Approved Date:

9-25-2018

Summary:

Chenega Professional & Technical Services (CPTS) is seeking a Medical Writer to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE).

Essential Duties and Responsibilities:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)

  • Serve as the medical writer for developing written documents pertaining to premarket safety, post-market safety, real-world data, risk management, and risk assessment as assigned by the OSE.

  • Work closely with subject matter experts (SMEs), the scientific lead, and senior leaders in OSE to collect, interpret, and synthesize information needed to develop each written document.

  • Perform quality reviews to ensure each document is accurate, consistent with FDA laws, regulations, guidance, and policies, includes all important concepts, meets the writing style requirements of the agency, follows the appropriate template and are written at an appropriate comprehension level for the intended audience.

  • Produce working and final drafts of each written document for review by SMEs and senior managers within OSE’s specified timeframes.

Non-Essential Duties:

  • Other duties as assigned.

Supervisory Responsibilities:

  • None.

Minimum Qualifications:(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)

  • Master’s degree in a health science, allied sciences, or public health-related field and at least 5 years of experience in writing and editing public documents in the federal government, pharmaceutical industry, or public health field.

  • FDA Sentinel experience preferred.

Knowledge, Skills and Abilities:

  • Combination of analytic and medical writing skills.

  • Demonstrate critical thinking skills, sound judgment, attention to detail, and strong organizational and communication skills.

  • Ability to quickly grasp complex technical concepts and synthesize the information in a written document.

  • Knowledge of epidemiology and/or pharmacovigilance is desired.

Diversity:

  • Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.

Ethics:

  • Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.

  • During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.

Chenega Corporation and family of companies is an EOE.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity

Native preference under PL 93-638.

We participate in the E-Verify Employment Verification Program.

M#

Organization: Chenega Professional & Technical Services

Title: Medical Writer (Part-time) - FDA/OSE

Location: Maryland-Silver Spring

Requisition ID: 1800003381