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 Specialist (Disclosure Medical Writer) will be primarily responsible for preparing clinical study registration and results disclosure postings in compliance with company policy and country laws and requirements. The disclosure team works collaboratively and independently to prepare disclosure documents for clinical studies in all therapeutic areas.

The Specialist will be responsible for:

• Authoring scientifically valid clinical trial registration and results postings on www.ClinicalTrials.gov (United States NIH public disclosure registry), the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) registry, and The Heads of Medicines Agencies (HMA)- European Medicines Agency (EMA) Catalogue of Real World Data (RWD) Studies (formerly EU PAS) registry for studies of varying complexity and therapeutic designation.

• Preparing study registration and results postings based on source documents (e.g., protocols, CSRs), negotiating content with internal and external reviewers, and guiding the posting through review and approval.

• Collaborating with clinical teams, including requesting necessary data and information, to ensure compliance with applicable legal requirements (Section 801 of the Food and Drug Administration Amendments Act and the Final Rule for Clinical Trials Registration and Results Information Submission [42 Code of Federal Regulations Part 11] in the US, and Directive 2001/20/European Commission and the Clinical Trials Regulation of the European Union).

• Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and incorporating review findings prior to finalizing for posting on public websites; and addressing NIH Quality Analysis review comments to resolve issues before resubmission when necessary.

• Participating in weekly MW&D-Disclosure meetings and scheduling meetings as needed with external teams.

• Assuring that Project Leads and management are informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality.

• Gaining expertise in the regulations associated with the disclosure of clinical study registrations and results in the United States and European Union and adapting to the changing regulatory environment as needed.

• Providing feedback on Standard Operating Procedures and Working Instructions as appropriate.

• As a secondary responsibility, the Specialist may occasionally prepare plain language (lay) summary trial results at a 6-8th grade reading level and provide input into the Health Literate Glossary.

Qualifications

• Bachelor's degree in Life Sciences or a related discipline.

Required Experience and skills:

AT LEAST ONE of the following or similar:

• Experience authoring protocol registrations and/or results disclosures on ClinicalTrials.gov or EudraCT.

• Experience in authoring International Council for Harmonisation clinical/regulatory documents (i.e., Clinical Study Reports, Protocols, etc.).

• Experience in technical or medical writing, familiarity with clinical research documents preferred.

• Experience in medical publications or regulatory product labeling.

Preferred Experience and Skills

• Good communication and interpersonal skills (both oral and written) in order to interact clearly, effectively, and tactfully with stakeholders.

• Strong attention to detail, strong analytical/logical thinking skills; able to critically evaluate data.

• Able to abstract information from source documents.

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

• Demonstrated team skills, professional values, and personal skills necessary for effective teamwork, able to work in cross-functional environment.

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

• Work style focused on problem-solving and maximizing accuracy.

• Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure.

MW20

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

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Requisition ID:R319856