Associate Director - Reporting, Archiving, Mapping
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Develops career plans for direct reports aligned to GDMS organization’s goals and provides developmental opportunities through the following methods:
Identifies challenging growth assignments.
Coaches for performance attainment in addition to communicates timely frequent feedback to support growth.
Performs periodic skill assessments evaluations as well as leads annual performance appraisals.
Shares rewards and recognition where appropriate
Facilitates team priority setting in addition to individual priority setting.
Ensures direct reports receive appropriate training and mentoring.
Develops promotion strategies and prepares promotion recommendations.
Possesses innovative mindset focused on continuous improvement and operational efficiency within team in addition to cross-functionally.
Displays collaborative approach in problem solving, governance, change management and appropriately synthesizes key business information to management where appropriate.
Identifies, facilitates, and directs work assignments aligned to resource availability and constraints.
Maximizes staff effectiveness by working with direct reports to ensure a realistic workload that supports value-added work and work-life balance, estimating length and difficulty of tasks and projects, anticipating, and adjusting for obstacles and setbacks, and elevating complex issues to the appropriate management level.
Participates in the recruitment, interview, candidate selection process in addition to performance improvement plan/termination as necessary.
Assumes specific functional leadership responsibilities for business deliverables assigned to direct reports or supervised staff on project.
Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts.
May serve as a functional area head with responsibilities for determining Standard Operating Procedures and other business practices for that area (including management of an operating budget)
Determines, collects, and interprets performance metrics. Identifies correction strategies and ensures they are implemented accordingly. Manage performance. Conducts management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations
Stays current in technology and regulatory changes both within and outside of our companies that may impact staff. May participate in or lead initiatives beyond GDMS (e.g. cross-divisional projects, cross-industry initiatives, etc.) May support any other project or perform any other data management or drug surveillance task deemed appropriate by management.
May supervise contingent, non-exempt, or temporary workers, onshore and offshore.
B.A. or B.S. degree or equivalent experience in relevant discipline.
Knowledge and Skills:
Minimum of 8 years’ experience in Clinical Development as appropriate to business role or related industry experience preferred.
3 years of supervisory or management experience preferred.
Strong knowledge of Clinical Development through submission Process, ICH, GCP guidelines and CFR 21 regulations related to Clinical Development and Technologies. Must understand the technology landscape of the Clinical Development and integrations of the different solutions.
Knowledge of database structures and available tools to manage, extract, and report data, general Technology aptitude.
Ability to find innovative and sustainable solutions to people, process, technology, and organizational issues.
Ability to adapt to constantly changing environment and to be able to contribute to the change as well.
Ability to work collaboratively with other functional areas, divisions, and vendors.
Ability to synthesize information from multiple sources, provide cohesive response, identify optimal path forward and communicate to management in clear, and concise manner and any actionable items.
Strong organizational, time management, problem solving and project coordination skills.
Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas.
Strong sense of urgency and leadership abilities.
Ability to present in a group environment.
Ability to lead a team.
Ability to be flexible, multi-task and work independently.
Basic knowledge of statistical concepts.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
Residents of Colorado
Click here to request this role’s pay range.
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.
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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:$130,960.00 - $206,200.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Merck & 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.
Flexible Work Arrangements:Hybrid
Shift:1st - Day
Valid Driving License:Yes