Senior Medical Writer Job at Meet Life Sciences, San Rafael, CA

ajh1QVhxU2FTM0VGMWM1WWNVZlRpQUFqbVE9PQ==
  • Meet Life Sciences
  • San Rafael, CA

Job Description

Job Summary:

We are seeking a detail-oriented and experienced Senior Medical Writer to join our clinical development team on a contract basis. The ideal candidate will apply advanced writing and document management skills to produce high-quality clinical and regulatory documentation supporting global drug development. This role involves close collaboration with cross-functional teams and adherence to regulatory standards.

Responsibilities:

  • Draft and edit regulatory submission documents (e.g., CTDs, RtQs), clinical protocols, protocol amendments, informed consent forms, investigator brochures, and safety reports (PSURs, DSURs).
  • Manage the full document lifecycle including planning, drafting, review coordination, comment adjudication, and finalization.
  • Facilitate cross-functional meetings and maintain timelines to ensure timely document delivery.
  • Apply regulatory and company writing standards, including AMA, CBE, and Chicago Style guidelines.
  • Interpret and present clinical data in text and table formats using appropriate scientific language and referencing.
  • Collaborate effectively with teams across Clinical, Biostatistics, Regulatory, Medical Affairs, and other functions.

Qualifications:

  • Bachelor’s degree or higher, preferably in a life science or medical discipline.
  • Minimum of 6 years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
  • Proven expertise in drafting clinical and regulatory documents, including protocols, clinical study reports, INDs, and BLA/NDA components.
  • Strong understanding of clinical research, regulatory requirements, and drug development lifecycle.
  • Familiarity with medical dictionaries (e.g., MedDRA, WHO Drug), biostatistics, and clinical coding practices.
  • Certification in medical writing or related training (e.g., AMWA, EMWA, DIA) is a plus.

Job Tags

Contract work,

Similar Jobs

Webfx.com

Jr. Front-End Web Developer Job at Webfx.com

 ...4 A Few Related Skills and Experiences (This is an entry-level role, and experience in every one of these areas is not required...  ...have an interest in the web and stay up-to-date on new and developing technologies You are a professional, dependable, and... 

Advantage PCA & Senior Care

Personal Care Assistant (PCA) Job at Advantage PCA & Senior Care

 ...Online access to paystubs 24/7 Client specific trainings Nursing Assistants can maintain an active registry Advantage PCA & Senior Care is a locally owned and operated home care agency that provides services to children, adults and seniors who need in-home... 

ClearanceJobs

ServiceNow Developer Job at ClearanceJobs

 ...divh2Sr. ServiceNow Developer/h2pTop Skills Details:/pulli3-7+ years of experience developing in ServiceNow/liliExperience with ServiceNow Discovery and CMDB/liliAbility to get a CompTIA Security+ certification within first 2 weeks of starting/liliActive Secret clearance... 

Oliverio Clips

Hair Stylist/Cosmetologist Job at Oliverio Clips

 ...repeat visits Keep your station clean, safe and fully stocked to GreatClips brand standards Requirements Valid Arizona cosmetology or barber license (provisional license or current student ok) Prior experience as hairdresser, barber, cosmetologist, or... 

Catherine Hershey School

Floater Lead Teacher Job at Catherine Hershey School

 ...New Danville - Lancaster, PA Full-Time The Floater Lead Teacher is a supportive team member, accountable for continuing to support...  ...that is passionate about our mission, brings in new creative ideas, and loves their work. If this sounds like you, we look forward...