Informed Consent Medical Writer

Job Description

The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers.

The Informed Consent Medical Writer (ICMW) role in Medical Writing & Disclosure (MW&D) department will be primarily responsible for preparing informed consent documents using health literate language per company process and standards to ensure compliance with internal policy, regulatory requirements, and health literacy principles.

The ICMW will be responsible for:

• Authoring accurate, clear and health literate clinical trial Informed Consents for studies of varying complexity across therapeutic areas that meet the International Council on Harmonisation (ICH) Good Clinical Practice and regulatory guidance pertaining to Informed Consent.

• Developing Informed Consents based with an understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document.

• Preparing and managing Informed Consents, with minimal supervision, a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines and governmental regulations in a clear, concise, and health-literate format.

• Collaborating with clinical teams, privacy, or other stakeholders to negotiate changes to text to ensure it is accurate and health literate.

• Identifies and proposes solutions to challenges in developing Informed Consents.

• Applies developing knowledge of Informed Consent medical writing-specific tools and technology platforms.

• Participates in initiatives to improve Informed Consent medical writing processes and standards.

Qualifications

Bachelor’s degree preferably in a Life Sciences related discipline 

Required Experience and skills:

• 3-5 years of experience in Informed Consent writing.

• Experience communicating medical and scientific information with patients or the public.

• 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 people skills (both oral and written) to interact clearly, effectively, and tactfully with stakeholders.

• High degree of organization and ability to manage simultaneous projects under tight timelines.

• Strong attention to detail and project management skills.

• Ability to work independently and collaboratively in a team environment.

Preferred skills:

• Understanding of the principles of clinical research and clinical trial design.

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

• Background in medical writing, authoring ICH clinical documents (i.e., Informed Consents, Protocols, etc.).

• Knowledge of International Council for Harmonization and Good Clinical Practice guidelines.

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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