Medical Writer Job at System One, San Anselmo, CA

VjBVVmdoTDlvVk5NZk9kczFUcU42bEFXSWc9PQ==
  • System One
  • San Anselmo, CA

Job Description

Job Order #: 329444
Title of Position: Medical Writer 
Location: San Rafael, CA 
Type: Contract 
Pay Rate: $50-$54/hr. W2 ONLY (NO STEM OPT CANDIDATES)

Hybrid (1-2 days in office to align with company policy).

The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
 
RESPONSIBILITIES
 
  • Drafts and edits documents used for submissions including CTDs and RtQs
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
  • Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Works effectively with cross-functional groups within COMPANY
  • Other tasks as assigned.
SUPERVISOR RESPONSIBILITY None.

CONTACTS:
Clinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance.
 
EQUIPMENT:
Access to corporate computer network, production computing environment, and MS Windows software.

Fulfills one of the following:
  • Medical writer in the pharmaceutical industry
  • Medical or scientific writing experience as a primary job responsibility
Skill and Experience:
  • At least 5 years experience required
  • Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
  • Familiar with clinical study data collection and results reporting.
  • Previous protocol development experience required.
  • Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
  • Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
  • Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
  • Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
  • Ability to interpret basic tabular and graphical clinical data presentations.
  • Ability to create basic tables using AMA style (eg, Schedule of Events).
  • Intermediate applied knowledge of basic clinical laboratory tests.
  • Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
  • Basic understanding of biostatistical and clinical research concepts.
  • Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
  • Experienced with scanners, printers, and copiers.
  • Basic knowledge of regulatory requirements and guidance’s associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
  • Capable of working on multiple tasks and shifting priorities.
  • Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
  • Good conflict management skills. Motivated and shows initiative.
  • Detail oriented. Capable of well organized, concise and clear written and verbal communication.
  • Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
  • Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
EDUCATION
  • Bachelor’s or higher degree; scientific focus desirable.
  • Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

Job Tags

Contract work, Work alone, Shift work,

Similar Jobs

K.A. Recruiting, Inc.

Psych Nurse Practitioner Job at K.A. Recruiting, Inc.

PSYCH NP NEEDED AT LARGE HOSPITAL LOCATED IN BEAUTIFUL AREA WHERE OUTDOOR RECREATION IS PLENTIFUL! We are looking for an APRN or Nurse Practitioner for this hospital employed, fulltime opportunity. The position will consist of 80% outpatient therapy new evaluations, follow... 

Jack Madden Ford Sales Inc

Automotive Sales Representative Job at Jack Madden Ford Sales Inc

 ...looking for motivated individuals who are interested in joining our sales team!Competitive pay plan and Dealer match 401kAutomobile...  ...,000.00 - $175,000.00 per yearBenefits: * 401(k)* Dental insurance* Health insurance* Paid time off Schedule:... 

N.Rich

Product UX/UI Designer (m/f) Job at N.Rich

 ...rapidly, we're looking for an experienced and self-driven Product Designer whos eager to dive deep into product details and customer pain...  ..., and iteration.About the TeamYou'll join the fully remote Product Development team, spread across 10+ locations. Youll work... 

Canary Closets

Warehouse & Cabinetry Production Assistant Job at Canary Closets

 ...Canary Closets & Cabinetry, a rapidly growing manufacturer of custom closets, doors, and cabinetry, is seeking a Warehouse & Cabinetry Production Assistant to join our fast-paced team. We are looking for a reliable, energetic, and self-motivated individual to support... 

Metro Associates

Home Health LPN RL129120 Job at Metro Associates

 ...Home Health LPN Full-time Qualifications Required: ~ Associate degree or higher ~1+ years of experience in ANY of the following:~ Electronic Medical Record (EMR)~ Other EMR ~ TruChart EHR Valid Licensed Practical Nurse (LPN) in the state of Pennsylvania...