Sr. Clinical Medical Writer

Location
USA, USA
Posted
Oct 28, 2020
Ref
162347
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM currently has several ETB candidates in clinical development to provide new treatments for B cell malignancies, multiple myeloma, breast cancer, gastric cancer, and immune-mediated solid tumors. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.

Location: Remote

Position Overview:

Molecular Templates is seeking a Senior Clinical Medical Writer to apply documentation preparation and document project management skills to the participation in and/or leadership in the development, drafting, review, editing, and finalization of documents used to conduct clinical studies and to report clinical study results for regulatory submissions and publications. The successful Medical Writer provides high-quality medical and scientific writing from planning and coordination of internal data into standard clinical development technical documents.

Job Responsibilities will include:
  • Reviews data including tables, listings, and figures, writes and edits clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation.
  • Collaborates with cross-functional team members (Clinical Development, Clinical Operations, Regulatory Affairs) to develop high-quality clinical study protocols (CSPs), investigator brochures (IBs), synopses, Clinical Study Reports (CSRs), informed consents (ICF), regulatory documents, clinical publications, and other related clinical documents.
  • Assists in the development of medical writing formats and guidelines for clinical documentation.
  • Effectively manages medical writing projects to deliver quality products in agreed upon timelines.
  • Collaborates with internal and external clients (i.e. data managers, biostatisticians), supporting and enabling effective and efficient communication (i.e. comment resolution, creating plans for document development) that results in operational excellence.
  • May assist Research and Development teams in pre-clinical documentation for medical congress abstracts and posters.
  • Keeps abreast of professional information and technology through conferences.

Qualifications:
  • Bachelor's degree with a scientific focus, required; advanced degree preferred
  • 10+ years of medical/clinical writing experience as a primary job responsibility
  • University-level medical or technical writing courses or equivalent experience in scientific/technical writing, required
  • Evidence of medical writing career development desirable (e.g., AMWA certification, BELS certification, DIA training, etc.)
  • Familiarity with the drug development process (discovery to market), clinical study protocol design and study conduct, documentation required for the conduct of clinical studies, and clinical study data collection and results reporting
  • Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates
  • Experience writing protocols, investigator's brochures, periodic safety reports, informed consent documents and clinical study reports. Review and/or editing experience alone is not sufficient.
  • Proficient in the use of Windows-based office applications. Extensive experience in Microsoft Word (including the use of templates).
  • Experience working with Adobe Acrobat (creating and editing PDF files) and document review systems.
  • Capable of working on multiple tasks and shifting priorities

Reporting Structure:

This position does not have supervisory responsibilities. This position's supervisor is TBD but will work on our Clinical team.

Molecular Templates Inc https://mtem.isolvedhire.com