Senior Medical Writer, Regulatory Docs (Late-Phase)
$80.6k - $145kSyneos Health/ inVentiv Health Commercial LLC
Syneos Health/ inVentiv Health Commercial LLC is seeking a Senior Medical Writer specializing in regulatory documents, responsible for leading the medical writing process for clinical studies and ensuring document accuracy against regulatory standards. The ideal candidate will have extensive experience and serve as a mentor to junior writers while fostering excellent client relationships. The role includes competitive benefits, a flexible work environment, and a salary range of $80,600.00 to $145,000.00, dependent on qualifications and experience. #J-18808-Ljbffr
$80.6k - $145k
...Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization...SeniorRegulatoryContract workFlexible hours$70 - $117 per hour
...Planet Pharma Group is seeking a Senior Regulatory Lead in North Carolina to provide strategic guidance for late-stage clinical programs. You will be pivotal in leading global regulatory strategies for Phase III clinical programs, especially for vaccines. With 12-15 years...SeniorRegulatory- ...ProPharma seeks an experienced Medical Writer in Raleigh, NC, to author and manage medical writing... ...deliverables across clinical research phases. The ideal candidate will have at least 5 years of experience in clinical or regulatory writing and a Bachelor's degree in a...SeniorRegulatoryRemote work
- ...expertise that empowers biotech, medical device, and pharmaceutical... ...deep domain expertise in regulatory sciences, clinical research solutions... ...documents) across all phases of clinical research and in various... ...less experienced medical writers, as necessary. Adhere to established...SeniorRegulatoryContract work
$95k - $210.9k
Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred Syneos Health® is a leading fully... ...needed and knowledge of therapeutic areas in all phases of clinical development desired. Proficient in MS Word...SeniorRegulatoryContract workFlexible hours- ...Syneos Health/inVentiv Health Commercial LLC is looking for a Medical Writer in North Carolina. This role involves leading medical writing... ...for clinical studies, and ensuring compliance with regulatory standards. The ideal candidate should have 3-5 years of experience...SeniorRegulatory
- ProPharma in Raleigh, North Carolina, seeks a skilled medical writer with at least 5 years of experience. The role involves authoring a variety of clinical and regulatory documents while ensuring adherence to regulatory standards. The ideal candidate will demonstrate strong...SeniorRegulatory
$114k - $210.9k
Senior Clinical Project Manager - Inflammation / Phase 2b (Sponsor Dedicated - Remote; Preference for Hybrid Foster City... ..., SOPs, and applicable regulatory requirements. Oversee inspection... ...car allowance. Health benefits: Medical, Dental, and Vision. Company match...SeniorRegulatoryRemote jobFlexible hours- ...Senior Clinical Project Manager – Oncology/Hematology (Phase III) (Remote – US/Canada) Are you a seasoned CRO project leader passionate... ...teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and QA....SeniorRegulatoryContract workRemote work
- ...Syneos Health, Inc. is seeking a Sr. Principal Regulatory Medical Writer located in Morrisville, NC. You will develop regulatory submissions, manage writing projects, and collaborate with cross-functional teams to ensure high-quality deliverables. The ideal candidate will...SeniorRegulatory
$70.1k - $145k
...Syneos Health, Inc. is looking for a Medical Writer II to lead the creation and management of critical medical documents. This role requires... ...in medical writing and a strong understanding of FDA regulatory standards. Responsibilities include collaborating with clients...SeniorRegulatoryFlexible hours$80.6k - $145k
...Syneos Health, Inc. is looking for a Sr Medical Writer specializing in redaction for clinical trial transparency. Located in Morrisville, NC, the role involves ensuring compliance with regulatory standards and providing quality assurance on various clinical documents....SeniorRegulatoryFlexible hours- ...Syneos Health, Inc. is seeking a Senior Medical Writer in Morrisville, NC, to lead and execute comprehensive medical writing deliverables.... ...development and emphasizes coordination across departments to meet regulatory standards. The ideal candidate will have 3–5 years of...SeniorRegulatory
$80.6k - $145k
...organization located in Morrisville, NC is seeking an experienced Medical Writer to ensure the accurate completion of medical writing... ...role involves managing complex writing projects, adhering to regulatory standards, and mentoring junior writers. The successful candidate...SeniorRegulatory- ...Strategy, Real World Evidence and Late Phase Updated: Today Location:... ...leadership. Coordinate the necessary medical/scientific input from outside... ...study types Background in senior‑level role in pharma or CRO... ...areas. Thorough knowledge of Regulatory requirements and the clinical...RegulatoryContract work
- ...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...SeniorRegulatoryFull timeContract work
- ...Medical Writer – Medical Information (Thermo Fisher Scientific, North Carolina) Work Schedule... ...specific to the peri‑ and post‑approval phases of the product lifecycle. Research and... ...following organizational, client, and regulatory guidelines. Participate as required in...RegulatoryWork at office
- Syneos Health, Inc. is looking for a Senior Medical Writer based in Morrisville, NC. This role involves writing, editing, and coordinating clinical and regulatory documents while serving as a technical contact. Candidates should possess strong medical writing skills with...SeniorRegulatoryFull timeFlexible hours
$95k - $210.9k
Sr. Principal Regulatory Medical Writer - Oncology Preferred Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25108891-OTHLOC-1500-2DIL-2DR Sr. Principal Regulatory Medical Writer - Oncology Preferred Job Responsibilities Develop regulatory documents...SeniorRegulatoryContract workFlexible hours$249.97k - $388.13k
...Senior Director, Global Medical Safety physician (psychedelics), leads and supports safety... ...leadership for Otsuka's late-stage psychedelic... ..., operational, ethical and regulatory considerations associated with... ...authors safety content for Phase 2/3 protocols as well as global...SeniorRegulatoryTemporary workLocal areaFlexible hours- MMS Holdings Inc is looking for a Senior Biostatistician in Raleigh, North Carolina. This... ...statistical analysis plans for phases 1-4. Candidates should have a strong background... ...includes collaboration with clients and regulatory bodies while ensuring compliance with ICH...SeniorRegulatory
- ...and EDC systems. The successful candidate will work with little supervision, ensuring compliance with various regulatory requirements while supporting all phases of clinical studies. Candidates must reside in the southeastern United States and be willing to travel...SeniorRegulatoryWork at officeWorldwide
$249.97k - $388.13k
...experienced and visionary Senior Director, Global... ...standards of scientific and medical integrity. The... ...global clinical trials and regulatory filing activities. The... ...of concept through late-stage trials and regulatory... ...experience in all developmental phases including evaluation of...SeniorRegulatoryTemporary workLocal areaFlexible hours- ...research activities at sites participating in Worldwide’s clinical research projects, ensuring compliance with regulatory requirements, and supporting all phases of the clinical study. Key Responsibilities Manage research activities at sites for all stages of the...SeniorRegulatoryContract workWork at officeRemote workWorldwide
- ...Senior Manager, Regulatory Strategy ICON is a global healthcare intelligence and clinical research... ...clinical trials, interpreting complex medical data, and contribute to the advancement... ...interactions with regulatory agencies, early phase consulting, development planning (PDP/...SeniorRegulatory
- ...development, preclinical and clinical research, regulatory affairs, and market access and... ...a motivated and experienced Director or Senior Director of Business Development to join... ...for Veranex, including multi-year, multi-phase programs providing substantial and predictable...SeniorRegulatoryContract workTemporary workRemote work
- ...along with experience in clinical trials. Ideal candidates will have a Bachelor's degree, over 10 years of relevant experience, and knowledge of regulatory submissions. Benefits include comprehensive insurance plans, vacation days, and a 401(k) match. #J-18808-Ljbffr...SeniorRegulatory
- ...RK&K is seeking a Senior Project Delivery Leader to guide and help grow our established... ...oversight for planning, design, and construction‑phase services for water/wastewater... ...rehabilitation programs. Familiarity with regulatory, funding, and permitting considerations affecting...SeniorRegulatoryLocal area
$122k
...Senior Project Manager (Neuroscience) – Premier Research Premier Research... ...the global project team, including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support... ...managing complex trials, multiple phases, and full lifecycle. Global experience...SeniorRegulatory- ...ITG Brands in North Carolina is looking for a Senior Regulatory Counsel to lead regulatory strategy and ensure compliance across federal and state tobacco regulations. The successful candidate will have a Juris Doctor (JD) and over 10 years of experience in a highly regulated...SeniorRegulatory
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