(Senior) Scientific Operations Manager
(Senior) Scientific Operations Manager
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1 Vacancy
Job Description
Job Description
Join the premier biopharmaceutical companythat has been in the Asia Pacific (AP) for over 60 years.
Be part of best-in-class Medical Affairs Team and be at the center of innovation and excellence in execution.
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
What will you do in this role:
Lead the Regional Scientific Operations Sub Team to provide operational support for assigning a variety related activities across AP countries.
Global/regional/local medical & scientific affairs studies (including Local Data Generation (LDG) HECON Post Approval Studies/Researches Company Investigator Studies Program and In Scope Research Types (interventional or non-interventional) and Pre-License Patient Access (PLPA) Programs across 2 markets. Assist line manager in constructing and managing the Regional Scientific Operations team of in-sourced personnel. Train local field medicals/study leads on subjects related to study operations and corresponding SOPs.
Scientific Operations management expectations include:
Develop maintain and monitor project plans project schedules budgets and expenditures in compliance with local regulations and company SOPs and Policy.
Organize and participate in project meetings (e.g. captures meeting minutes tracks action items contribute own perspectives etc.)
Proactively discuss with study leads and line managers to assess project risks and issues and provide solutions where applicable
Track project progress and provide project updates/summaries
Navigate internal processes and procedures including compliance and finance to ensure compliant execution of assigned projects
Ensure projects adhere to frameworks and all documentation is maintained appropriately for each project.
Publication Tracking.
Medical Scientific Operations Management - Study Activities
Lead and/or participate in the team to work with study lead to plan initiate conduct and manage a series of local/regional/global planned non-interventional studies with Global Medical Scientific Affairs and related Staffs:
Lead and/or participate the team to plan initiate conduct and manage a series of local/regional planned CompanyInvestigator Studies Programand In Scope Research Types (interventional or non-interventional) with Global Medical Scientific Affairs and related Staffs:
Timely track the publication status of GMSA studies (submission time acceptance/rejection conference journal).
Publication includes conference poster abstract oral presentation and manuscript published in peer-reviewed journal.
Regularly track and provide status updates to study leads and country medical directors execute all study related administrative tasks such as execute contracting and study payment arrange study material allocation and delivery arrange SIV/PI meetings budget management and monthly accrual etc.
Medical Scientific Operations Management - PreLicense Patient Access Programs (PLPA)
Work with project lead to Implement and track GMSA-Owned PreLicense Patient Access Programs (PLPA) and ensure the execution quality under the supervision of manager
Conduct AE/PQC reconciliation process with GPV team to align with Global Pharmacovigilance Policy/SOP.
Execute Good Documentation Practice through out for all GMSA studies Events & activities and PLPA programs.
Involve or/and conduct internal audit inspections and other quality assurance activities.
Provide recommendation or trainings for continuous improvement risk management control and knowledge transfer of Medical Scientific Affairs Projects within the company.
Support Medical Scientific Affairs in driving operational excellence and help build the Regional Scientific Operations team structure.
What You Should Have
Bachelors degree or Masters Degree in pharmacy or related healthcare or scientific discipline.
Experience 8 years experience within clinical/observational research or equivalent experience; 3 years of experience in project management vendor management and budget-planning.
Demonstrated pharmaceutical industry experience with a proven track record of leading large complex multi-stakeholder projects.
Core:
Strong project management skills and sense of urgency
Have ability to deal with ambiguity
Clinical study execution related knowledge including but not limited to GCP GPP IRB submission HA submission site initiation/close out site management liaise with vendors budget planning/management study drug import specimen export etc.
Strong interpersonal verbal and written communication skills to work with medical and/or scientific teams
Ability to independently handle multiple projects and priorities simultaneously and function in a fast-paced environment
Experience working effectively both independently and as part of a team
Ability to quickly and comprehensively learn about new subject areas and environments
Self-motivation flexibility resourcefulness and problem-solving capabilities passion for science
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 worlds 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 usand start making your impact today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
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.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Business Intelligence (BI) Reporting Clinical Project Management Communication Data Analysis Decision Making Internal Auditing Knowledge Management Management Process Medical Affairs Medical Knowledge Medicines Australia Code of Conduct Meeting Organization Microsoft Office Microsoft PowerPoint Military Medicine Pharmaceutical Regulatory Compliance Pharmacovigilance Project Management Project Planning Project Risks Quality Assurance Processes Requisition Management Stakeholder Engagement 5 morePreferred Skills:
Job Posting End Date:
10/31/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
