Disclosure Analysts

Job Description

Job Description:

The Medical Writing & Disclosure (MW&D) 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 Executive Director in Medical Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations, external data sharing, and authoring lay summaries and informed consent in compliance with global regulations and company policies. Additionally, they will manage a large team of medical writers and specialists, engage in external activities to align the company with regulatory changes, act as the point of contact for external inquiries related to transparency, and provide strategic leadership in health literacy and compliance with global disclosure requirements.

Primary Responsibilities:

Responsible for clinical trial data registration, results postings, redaction operations, external data sharing, authoring lay summaries and informed consent in alignment with global regulations and internal company policies. Responsible for managing all external requests for clinical data. Periodic review of metrics and identification of process improvement needs. Responsible for management of staff of up to 60+ medical writers and specialists to complete all authoring, approval, and posting activities; Plain Language Summaries, Informed Consent, and redaction operations. Staffing model is ~10% flex staff. Participate in external engagement activities to best align our company for changes to regulations and general transparency practices. Our company's point of contact for all external inquiries related to transparency policies, challenges to regulations, and impact assessments for new guidelines. Working closely with Legal and Communications to make decision on need for response and best method for communicating. Provide strategic thinking and leadership in health literacy across the enterprise. Assess ongoing health literacy activities across Research & Development (R&D), optimizing systematic integration. Partner with legal and key stakeholders to update informed consent templates. Drive adoption of cultural competence, health literacy, and teach back in clinical investigator training. Ensure policies and procedures are in place to deliver on 100% compliance with global disclosure requirements, data access and all voluntary company policies. Review and approve local country disclosure SOP's to ensure alignment with FDAAA and EudraCT process and data content. Develop strategies to maintain public data consistency across global registries and in publications. Provide strategic direction for new processes and technologies to ensure compliance across global registries.

Education:

Required: Bachelor's Degree

Preferred: Master's Degree or advanced education in related field (Business, Public Health, or similar)

Required Experience and Skills:

10+ years biotech/pharmaceutical industry experience Project management skills; focus on quality and efficiency Understanding of global regulations for clinical trial disclosure activities People management skills; ability to manage workload across FTE and contractor staff Strong relationships with internal stakeholders (OCMO, Legal, Compliance, GRA, and Communications) Demonstrated track record of innovation and leadership, developing and deploying strategic solutions with tangible results for policy, business, and diversity Proven collaborator with the ability to work across functions and regions, accomplishing specific goals without direct authority Ability to inspire passion for health literacy and health equity, driving ownership across divisions and regions Proven success in leading complex, large-scale, cross-functional highly visible programs within a large health care organization setting Demonstrated excellent interpersonal, written and oral communication, presentation, organization, networking and public relations skills Strong communicator with the ability to clearly articulate messages/information across the enterprise, to all levels, including senior leaders Significant experience working with oncology and vaccine confidence business areas

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. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.

Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model: 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, generally Tuesday, Wednesday and either Monday or 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: $243,500.00 - $383,300.00 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 .

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Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 09/20/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date: 09/20/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R311099

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Additional Information