Director, Informed Consent Medical Writer
Job DescriptionThe 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 Director, Informed Consent Medical Writer (ICMW) is responsible for the development and management of informed consent deliverables that support the clinical regulatory writing portfolio while ensuring compliance with internal policy and procedures, regulatory requirements, and health literacy principles.The responsibilities of the Director ICMW are to:
Produce high-quality and timely documentation in line with health literate clinical trial informed consents for studies of varying complexity across therapeutic areas.
Oversee work of other informed consent medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments while promoting an audit ready environment.
Execute functional business plans and contribute to the development of the ICMW group and the department’s objectives by engaging strategically with key stakeholders across department, division, and company. Role requires proactive partnering, strategic thinking, and leadership to envision, plan, and execute operational projects.
Contribute to department management through strategic input, continual process improvement, innovation, collaboration with internal and external stakeholders, and leadership for ICMW processes, standards, and initiatives.
Serve as a subject matter expert and represent the company regarding insight into informed consent regulatory intelligence, health literacy and industry trends to assess and strategize business activities impacted by new or modified requirements through external partnerships, collaborations, and key strategic engagements.
Provides strategic direction for informed consent processes and technologies to ensure compliance with International Council on Harmonisation (ICH) Good Clinical Practice and regulatory guidance pertaining to Informed Consent.
Lead, coach and develop staff and manage priorities and employee performance and development in alignment with business needs and staff developmental opportunities.
QualificationsBS/BA in health-related, life science or analytical related field.Required Experience:
10+ years pharmaceutical and/or clinical drug development experience.
Organization leadership (e.g., program management) and people management experience.
Expert knowledge and understanding of informed consent guidance and regulation, end-to-end drug development and clinical trial processes.
Required Skills:
Demonstrated ability to drive and manage highly complex topics related to informed consent activities.
Strong decision-making and analytical skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
Strong people management skills to enable resource management and development management of direct reports.
Possess advanced understanding of end-to-end clinical research process.
Demonstrated leadership skills in managing people, programs & processes, leading meetings and influencing matrix environments.
Advanced problem solving, conflict resolution, and critical thinking skills.
Expert knowledge of GCP and ICH regulations and corporate policies.
NOTICE FOR INTERNAL APPLICANTSIn 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.MW20#eligibleforERPCurrent Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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:$164,800.00 - $259,400.00Available 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 (https://www.benefitsatmerck.com/) .San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:RemoteShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:10/22/2024A 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: R316081