Ref #: 33476

Employment type: Permanent - Full-Time

Location: US - Nationwide (Remote)

Posted: 31-Dec-2021

Description

ICON GSS is searching for Medical Writers for a dedicated sponsor. This is a home-based position.

The CDD&T Medical Writer will prepare trial disclosure documents in compliance with trial transparency laws and requirements and client policies.

Position Summary:

Clinical trial registration and results posting on www.ClinicalTrials.gov; results posting on EudraCT.
Coordinating quality assurance reviews of documents and maintain audit trails of changes.
Prepares scientifically valid draft and final results summaries for posting to ww.ClinicalTrials.gov and EudraCT, inclusive of the scientific interpretation of data, and the writing of clinical, pharmacokinetic and pharmacodynamic results for studies of varying complexity and therapeutic designation.
Complete work in a timely and accurate manner in accordance with Client Standard Operating Procedures and FDA/EMA regulatory requirements.
Assures study registrations and results postings are in accordance with FDAAA (Food and Drug Administration Amendments Act of 2007) compliance, EMA guidelines, and the client SOPs.
Performs review of results summary content and validity for studies as assigned and works with the TA Lead/Trial Transparency Specialist as needed to resolve any issues with the clinical project team before the results are finalized and ready for posting.
Responds to Client comments on the results summaries; amends summaries as appropriate and incorporates review findings prior to finalizing for posting on www.ClinicalTrials.gov/EudraCT.
Identifies and resolves problems related to the production of summaries and posting of results.
Communicates with internal staff and appropriate external study contact(s) to obtain all relevant information needed to assure work is completed in accordance with the project schedule.
Consults with internal/external clients to determine posting requirements and suggests/guides plans to accomplish these needs.
May represent the department in inter-department and working groups.
May be responsible for interacting with international study teams to ensure timely reporting of study results
Assures management is informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality.
Perform other duties as assigned.

Qualifications:

Minimum 5-7 years’ experience working in a medical writing capacity, experience authoring clinical documents (i.e., Clinical Study Reports, Protocols, etc.) strongly preferred, experience performing CT.gov tasks preferred.
Clinical/regulatory process experience or in a pharmaceutical environment a must
Knowledge of ICH and GCP guidelines required
Demonstrated ability to prepare and finalize clinical documents (i.e., Clinical Study Reports, Protocols, etc.)
Good communication skills, both oral and written are mandatory in order to clearly, effectively, and tactfully interact with Client stakeholders
International study experience a plus
Demonstrated ability to be customer-oriented and to achieve high customer satisfaction levels
Demonstrated ability to prioritize and manage multiple tasks
Ability to attend to detail, think logically and critically evaluate and solve problems
Demonstrated good judgmental and independent decision-making abilities, as well as strong follow-up skills
Demonstrated team skills, professional values and personal skills necessary for effective teamwork
Ability to work with multiple study teams in one or more therapeutic areas
Computer literacy required
Minimum Bachelor’s Degree with a science background required; advanced degree preferred

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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