Principal Medical Writer- Clinical & Regulatory Strategic Communications
$142.4k - $224.1kFull-time
Merck
Job Description The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. The Principal Medical Writer, in partnership with a project lead, leverages strategic and scientific expertise to develop, author, edit, and lead the review of accurate, clear, and compliant clinical, regulatory, and/or public-facing documents, across multiple programs and therapeutic areas, in support of the company portfolio. In this role, the Principal Medical Writer:
Clinical Data Management, Clinical Operations, Clinical Study Design, Clinical Study Management, Clinical Trials Operations, Collaborative Leadership, Ethical Standards, Leadership Theories, Medical Studies, Medical Writing, Project Leadership, Project Management Oversight, Project Team Management, Regulatory Compliance, Regulatory Processes, Regulatory Requirements, Stakeholder Alignment Preferred Skills: 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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 The salary range for this role is
$142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 Los 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 Ordinance 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:
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:
09/7/2026
*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: R415702
- Is recognized as a subject matter expert in the design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy) and evolving regulatory requirements.
- Is recognized as a strong scientific contributor and collaborator on cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
- Applies critical thinking, problem solving, and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics.
- Provides program oversight by keeping project leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.
- Demonstrates expertise in medical writing-specific tools and technology platforms.
- Leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate.
- Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products. Demonstrates a developing understanding of the pharmaceutical industry beyond clinical research.
- Provides scientific and operational mentorship, coaching and/or project oversight to support other medical writers.
- May manage direct reports including workload, professional development, and performance management.
- Required: Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 5 years of relevant medical writing or industry experience.
- Experience managing complex writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
- Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.
- Demonstrated critical thinking and problem-solving capabilities, with an ability to innovate, influence, and drive change.
- Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making.
- Excellent oral and written communication and presentation skills.
- Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.
- Experience independently preparing a different set of clinical regulatory documents (e.g., protocols, clinical study reports, clinical submission documents) in accordance with regulatory requirements and industry guidelines.
Clinical Data Management, Clinical Operations, Clinical Study Design, Clinical Study Management, Clinical Trials Operations, Collaborative Leadership, Ethical Standards, Leadership Theories, Medical Studies, Medical Writing, Project Leadership, Project Management Oversight, Project Team Management, Regulatory Compliance, Regulatory Processes, Regulatory Requirements, Stakeholder Alignment Preferred Skills: 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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 The salary range for this role is
$142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 Los 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 Ordinance 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:
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:
09/7/2026
*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: R415702
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Principal Medical Writer- Clinical & Regulatory Strategic Communications in Delaware, OH vacancy
$87k - $102k
...where your work matters. The Finance Strategic Initiatives Senior/Principal offers the opportunity to shape... ...Corporate FP&A, Risk Management, Regulatory, Executive Management, and other corporate... ..., assess business impacts, and communicate insights clearly to project teams...PrincipalRegulatoryFull time- ...solutions for data centers, communication networks, and... ...competitive technologies, and regulatory developments in... ...to help execute our Strategic Priorities.OUR CORE... ...Inclusion.OUR CORE PRINCIPALS: Safety. Integrity. Respect... ..., or related medical conditions), marital...PrincipalRegulatoryTemporary workWorldwide
$86.7k - $173.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...are at the highest level of all Clinical Specialists in the region.Acts as the most... ...developments in field(s) of expertise, regulatory requirements, and a good working knowledge...PrincipalRegulatoryShift work$25k
...Join Our Caring CommunityAs a Clinical Manager at CenterWell Home... ...documentation quality, and regulatory compliance, working onsite in... ...improvement data.Coordinate communication among physicians, team members... ...benefits, Humana provides medical, dental and vision benefits,...RegulatoryTemporary workApprenticeshipWork at officeCenterWell
Delaware, OH4 days ago- ...construction management staff, environmental, strategic communications, economists, management consultants... ...connects employees around the world.Principal Project Manager roles at HDR are... ....Advise clients on the technical, regulatory, financial, and community facets of infrastructure...PrincipalRegulatoryContract workWork at office
- ...Director of Project Management to lead departmental timelines for Clinical Operations and Clinical Pharmacology. You will build scalable... ...into milestones, risks, and decisions. Working with Regulatory, Research, and Program Teams, you will translate strategies into...Regulatory
- ...60 free-standing outpatient clinics ( , a college of nursing ( ,... ...benefits packages including medical, dental, and vision coverage... ...more at ! About the job: Regulatory Specialist designs, directs... ...of thinking. Facilitates communication both external and internal...RegulatoryFull timeLocal areaRelocation packageFlexible hoursShift work
Trinity Health
Columbus, OH1 day ago - ...Consultant (RFC) to oversee the post-award financial management for clinical research studies and projects. You will manage invoicing,... ...to ensure accurate revenue capture, timely collections, and compliance with regulatory #J-18808-Ljbffr Berger Health SystemRegulatory
$238.99k - $358.49k
...advancing the pace of clinical study progress in the... ...engagement with strategic clinical research sites... ...headquarters-based teams across Medical Affairs, R&D,... ...in scientific communication, drug information exchange... ...knowledge of FDA compliance, regulatory requirements, Medical...RegulatoryTemporary workWork at officeFlexible hours3 days per weekDelaware, OH12 days ago$116k - $151k
...Summary: We are seeking a Principal Data Manager with... ...-up and execution of clinical trials when... ...accurate, high quality, and regulatory compliant data in support... ..., timelines and communication plans. Work cross-functionally... ...as lead CDM. Strategize and plan for database...PrincipalRegulatoryTemporary workRemote work- ...team. The role involves cross-functional analyses, Excel-based financial modeling, and risk evaluation to develop strategic programs addressing regulatory and market risks. The ideal candidate has 4–6 years of relevant experience and a Bachelor's degree in a related field...PrincipalRegulatory
NiSource
Columbus, OH15 hours ago - ...the enterprise leader responsible for clinical quality, regulatory compliance, and organizational risk,... ...position at the company should be strategic thinkers, calm and decisive during audits... ...collaborative with exceptional communication skills. The role requires a leader who...Regulatory
- ...Electric Power (AEP) in Columbus, OH, seeks a Finance Strategic Initiatives Senior/Principal to shape high-impact finance and accounting initiatives... ...companies, Accounting, Tax, Corporate FP&A, Risk Management, Regulatory, and executive management to solve complex challenges...PrincipalRegulatory
$115.4k - $192.3k
...will lead the accessibility program for a broad portfolio of Clinical Solutions products, ensuring they meet evolving accessibility... ...are before they become escalationsStay ahead of the legal and regulatory landscape — enforcement trends, emerging state statutes, and international...RegulatoryFull timeLocal areaImmediate startRemote workWork from homeFlexible hours- ...an experienced Project Manager to drive strategic initiatives within a dedicated client unit... ...ensuring patient-centered outcomes and regulatory compliance. You will coordinate with account management, engineering, product, clinical, operations, and data teams to translate...RegulatoryRemote job
- ...Principal ArchitectStep into the role of a Principal Architect at... ...domains.You will serve as a strategic technology leader, defining... ...with enterprise standards and regulatory obligationsBuilds trusted advisor... ...computingStrong communication and relationship-building skills...PrincipalRegulatory
Chase
Columbus, OH4 days ago - ...Shift: Description: Clinical Dietitian Why Mount Carmel... ...benefits packages including medical, dental, and vision coverage... ...performance improvement, and regulatory compliance. What you'l... ...andcourtesy,effective communication creates a professional environment...RegulatoryPart timeLocal areaShift work
Trinity Health
Columbus, OH5 days ago - ...combines the responsibilities of a Clinical Educator and a Staff RN. The... ...competency assessment, regulatory, accreditation and... ...others and communities, and communicates to the appropriate individual... ...committees, task forces and strategic planning meetings. 10% Project...RegulatoryFull timeLocal areaShift work
- ...Clinical Research Coordinator The Behavioral Trials Office (BTO) works with... ...trials (e.g., lifestyle, medication adherence, family communication, biofeedback, safe driving technology... ...regulations, study protocols, and other regulatory processes and systems, as well as...RegulatoryZero hours contractWork at officeFlexible hoursWeekend workAfternoon shift
Phenom People
Columbus, OH2 days ago $81.71k - $110.55k
...academic compliance initiatives as strategic priorities, maintains knowledge and application of regulatory standards, manages assigned... ...regulatory compliance and communicate identified concerns with AVP... ...with individuals tasked with clinical development for purposes of new...RegulatoryWork at officeRemote work- Abbott Laboratories seeks a Principal Clinical Specialist to lead advanced clinical support for its cardiovascular and electrophysiology portfolio. In this field-based role, you will provide expert case support in cath and EP labs, guide optimal device use, and train physicians...Principal
Abbott Laboratories
Columbus, OH5 days ago - ...will not be considered. A clinical pharmacist opportunity is... ...to apply your expertise in medication management and patient care.... ...documentation in compliance with regulatory standards. Participate in... ...management. Excellent communication skills for patient counseling...Regulatory
Soliant
Delaware, OH4 days ago $132k - $172k
Department: 106600 Clinical Operations Location: San Diego, USA-... ...status, timelines, enrollment, regulatory documentation, and site... ...changes in conjunction with Strategic Procurement. Track and manage... ...establishing and meeting SMT goals and communicate key issues and mitigations...RegulatoryContract workTemporary workRemote work$87.63k - $109.54k
...posting end date. Job Summary Regulatory professional who possesses... ..., and have the ability to communicate, organize, and coordinate work... .... Participate in strategic initiatives related to areas... ...experience. Regulatory Consultant Principal (Grade 8) Bachelor's degree...PrincipalRegulatoryWeekend work- ...will not be considered. A clinical pharmacist opportunity is... ...expertise in managing patient medication therapies within a clinical... ...records in compliance with regulatory standards Desired qualifications... ...care processes Excellent communication and interpersonal skills for...Regulatory
Soliant
Delaware, OH4 days ago - TELUS Digital is seeking a Principal, Business Development based in the Columbus area with hybrid/remote flexibility. You will lead strategic accounts and drive revenue growth in the Manufacturing and Energy verticals, coordinating across business development and marketing...PrincipalRemote work
- ...outreach management across the care continuum. The role emphasizes clinical program development, regulatory compliance, and collaboration with physicians, EMS, and system service lines to achieve annual strategic objectives and improve patient outcomes. #J-18808-Ljbffr...Regulatory
- ...Wells Fargo is seeking a Principal Engineer in... ...security, resilience, regulatory, and operational objectives... ...tactical and strategic business objectives,... ...automation at scaleAbility to communicate with engineers,... ...DisabilitiesTo request a medical accommodation during...PrincipalRegulatoryFull timeWork experience placementRelocation packageFree visa
- ...role:Wells Fargo is seeking a Principal Engineer in Cybersecurity as... ...organizations tactical and strategic business objectives, the... ...Financial Crimes, Operational, Regulatory Compliance), which includes... ...with DisabilitiesTo request a medical accommodation during the...PrincipalRegulatoryFull timeWork experience placementSecond jobRelocation packageFree visa
- ...School Based Director of Clinic Operations Summary The... ...meeting company strategic goals, key performance... ...and Patient Centered Medical Home (PCMH) certification... ...accordance with HRSA. Ensure regulatory and safety compliance... ...Influencing People: communicates effectively, drives...RegulatoryTemporary workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Medical Writer- Clinical & Regulatory Strategic Communications. Be the first to apply!
Related searches
- principal Delaware, OH
- advanced medical Delaware, OH
- correctional medical services Delaware, OH
- medical benefits Delaware, OH
- medical terminology Delaware, OH
- one medical Delaware, OH
- medical office no experience Delaware, OH
- medical electronics Delaware, OH
- event medical Delaware, OH
- pediatric medical Delaware, OH