Lead Medical Writer - Clinical & Regulatory Strategy
Glaxosmithkline
GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences. This role requires strong collaboration and communication skills to work with cross-functional teams. Benefits include a comprehensive program for US employees, along with opportunities for professional growth. #J-18808-Ljbffr GlaxoSmithKline
- GlaxoSmithKline in Durham, North Carolina is seeking a Principal Medical Writer to lead regulatory document preparation for complex clinical projects. This role demands excellent communication skills and a strong background in medical writing, with a focus on HIV-related...RegulatoryRemote job
- TG Therapeutics, Inc. in Morrisville, North Carolina is seeking an experienced Medical Writer to develop and manage high-quality clinical, regulatory, and scientific documents. This role involves close collaboration with cross-functional teams in a biotechnology environment...RegulatoryFull timeContract work
- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature... ...including quality, manufacturing, and clinical development. Strong written... ...information (including family medical history), military service or...RegulatoryLocal area
- Overview Lead and manage clinical data management activities for oncology clinical trials, ensuring... ...in alignment with study protocols and regulatory requirements. Oversee the design,... ...ensure alignment of data management strategies with overall clinical development goals...RegulatoryWork at office
- IQVIA LLC is seeking a Senior Medical Writer in Durham, North Carolina. The candidate will act as Lead Medical Writer on various projects, ensuring compliance with SOPs... ...medical treatments while ensuring adherence to regulatory standards. #J-18808-Ljbffr IQVIA LLCRegulatory
- Patient Engagement Lead - Global Clinical Trial Recruitment and Retention Updated: Yesterday Location... ...recruitment and retention (R&R) strategy and execution across clinical trials.... ...deliverables meet sponsor expectations, regulatory requirements, and internal quality...RegulatoryContract workImmediate start
- Belcan is seeking a Clinical Study Manager/Clinical Trial Manager in the United States to oversee day-to-day management of clinical studies... ..., and internal teams to ensure milestones, timelines, and regulatory compliance. A life-science degree and 8+ years in clinical...Regulatory
- ...The successful candidate will be responsible for leading clinical research studies, ensuring compliance with regulatory guidelines, and maintaining project financial... ...between the company and clients, and developing strategies for risk mitigation. Candidates should have a...RegulatoryFlexible hours
- Belcan Corporation in Durham, NC is seeking a Contract Clinical Study Manager to provide operational leadership and oversight for assigned studies, ensuring adherence to ICH/GCP, regulatory requirements, SOPs, and study plans across CROs, vendors, investigators, and sites...RegulatoryContract work
- Wisconsin Psychiatric Association Inc is looking for a Clinical Specialty Program Pharmacist responsible for managing relationships with... ...management and collaborating with clients to enhance clinical strategies. The ideal candidate will have a Bachelor's degree in Pharmacy...Remote job
$91.7k - $163.7k
Optum is seeking a Clinical Specialty Program Pharmacist to lead and manage client relationships from a remote location in the United States. This role... ...managing pharmacy benefit analysis, executing clinical strategies, and maintaining significant client interactions....Remote job$70.1k - $145k
Syneos Health, Inc. in Morrisville, NC, is seeking a Senior Medical Writer to lead the writing of clinical and regulatory documents. This role requires expertise in FDA and ICH regulations and prior experience in the biopharmaceutical sector. Responsibilities include managing...Regulatory$84.4k - $211.1k
...Job Overview Acts as Lead Medical Writer on any type of writing project, including projects with multiple deliverables/components... ...of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances...RegulatoryFull timePart time- ...impact of HIV on individuals and communities.ViiV Healthcare is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical, and cross-...RegulatoryLocal areaRemote work
$84.4k - $211.1k
...Job Overview: Acts as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance... ...abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances...RegulatoryFull timePart timeLocal areaImmediate startWorldwide- ..., North Carolina, is seeking a Vice President (VP), GDNF Clinical Development to lead strategic clinical initiatives for gene therapy products.... ...clinical development experience. This role supports global regulatory approvals and commercial launches. #J-18808-Ljbffr...Regulatory
$80.6k - $145k
A leading life sciences organization located in Morrisville, NC is seeking an experienced Medical Writer to ensure the accurate completion of medical writing deliverables. This role... ...complex writing projects, adhering to regulatory standards, and mentoring junior writers...Regulatory- Principal Medical Writer ViiV Healthcare, a global specialty HIV company, is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical...RegulatoryLocal areaRemote work
- ...(RMS), to include clinically isolated syndrome,... ...Healthcare Products Regulatory Agency (MHRA) for... ...visit Role The Medical Writing function plays... ...for authoring and leading clear, accurate,... .... The Medical Writer collaborates closely... ...align on document strategy, messaging, and...RegulatoryFull timeContract workVisa sponsorshipWork visa
$95k - $210.9k
Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at...RegulatoryContract workFlexible hours$220k - $245k
...executive leader for Quality Assurance and Regulatory Compliance in the Clinical Pharmacology Services business unit... ...candidate will influence quality strategy, manage QA teams, and ensure... ...for eligible employees, including medical, dental, vision, and 401(K). #J-18...Regulatory- Duke University Health System seeks a Clinic Manager for the Orthopaedics clinic in Morrisville, NC. The role involves overseeing daily... ..., ensuring high-quality patient care, and compliance with regulatory standards. Responsibilities include staff management, operational...Regulatory
$149.33k - $248.88k
Position Summary You will lead small molecule drug... ...development through clinical and commercial manufacturing... ...development, quality, regulatory, manufacturing and... ...concepts and control strategy development. Proven ability... .../parental and medical leave. Please visit GSK...RegulatoryContract workLocal areaRemote work- Worldwide Clinical Trials in Durham, NC seeks a Clinical Scientist in Oncology to lead review and interpretation of clinical data, ensuring quality and integrity and supporting regulatory deliverables such as CSRs and INDs. You will partner with cross‑functional teams to...RegulatoryWorldwide
- Aerogen Pharma, located in Morrisville, NC, is seeking a Clinical Trial Manager to oversee various aspects of clinical trials, including... ...in clinical operations and a strong understanding of regulatory requirements. The ideal candidate will demonstrate critical thinking...Regulatory
$70.1k - $145k
...DMT-2DR Syneos Health® is a leading fully-integrated life sciences... ...accelerate progress. Our Clinical Solutions team members act with... ...pace of patient progress. Medical Writer II – Publications Job Responsibilities... .... Adheres to established regulatory standards, including, but...RegulatoryContract workFlexible hours$80.6k - $145k
...Overview Syneos Health® is a leading fully-integrated life... ...completion of medical writing deliverables,... ...documents that may include clinical study protocols and... ...Adheres to established regulatory standards, including ICH... ...experienced medical writers on complex projects. Develops...RegulatoryContract workFlexible hours- ## Lead Procurement Analyst, Category ManagementApplyremote... ..., you’ll support clinical research by partnering... ...(Clinical Operations, Medical Affairs, etc.) to... ...development of sourcing strategies and improving sourcing... ...health, safety, and regulatory requirement* Ensure that...RegulatoryWork at office3 days per week
- IQVIA Argentina is seeking a Principal for COA Strategy Consulting to lead client projects and business development in a collaborative environment... ...in pharmaceutical consulting, strong expertise in Clinical Outcomes Assessments, and exceptional communication skills...
- Labcorp is seeking a Senior Lead Biostatistician -... ...on observational clinical validity studies in minimal... ...design, analytical strategy, and execution to ensure... ...study documentation and regulatory standards (e.g.,... ...comprehensive benefits including: Medical, Dental, Vision, Life,...RegulatoryTemporary workCasual workMonday to FridayFlexible hoursDay shift
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