Sr. Medical Writer (Regulatory/Remote) - Consulting Opportunity
Company: ProPharma Group
Location: San Jose
Posted on: November 23, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
The Senior (Sr.) Medical Writer provides medical writing and
publication support for clients.
Essential Functions Include
- Mentors and leads less experienced medical writers on complex
projects, as necessary.
- Compiles, writes, and edits medical writing deliverables, and
serves as a medical writer on inter-department and intra-department
project teams with minimal supervision. Provides medical writing
deliverables covering all phases of clinical research and in
various therapeutic areas.
- Creates writing deliverables that include, but may not be
- clinical study protocols and clinical protocol amendments;
- clinical study reports;
- clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- investigator brochures, as well as;
- clinical journal manuscripts, clinical journal abstracts, and
- Reviews statistical analysis plans and table/figure/listing
specifications for appropriate content, and for grammar, format,
- Interacts with department head and staff members in data
management, biostatistics, regulatory affairs, and medical affairs
as necessary to produce writing deliverables.
- Adheres to established regulatory standards, including but not
limited to ICH-E3 guidelines, as well as Company Standard Operating
Procedures, client standards, and Company and/or client approved
templates when completing medical writing projects, on-time and
- Performs on-line clinical literature searches, as requested.
Maintains familiarity with current industry practices and
regulatory requirements and guidelines that affect medical
- Coordinate quality control reviews of documents and maintaining
audit trails of changes.
- May perform quality control (QC) review if requested by
supervisor (e.g., QC in-text tables against statistical tables,
verify titles in standard table of contents, paginate a document,
Qualified Candidates Must Have
- Bachelor's degree in the life sciences; MS or PhD
- Minimum of 5 years of experience in the writing regulatory
documents for pharmaceutical, biologic or medical device
- Expert word processing skills in MS Word, including proficiency
with tables, graphs, and figures are required.
- Must be able to work in a collaborative team environment.
- Strong computer skills, project management skills, and a high
attention to detail.
- Excellent demonstrable understanding of ICMJE and GPP
guidelines and regulations required.
- Ability to write presentations and articles for peer reviewed
publications that conform to prescribed style and format.
- Ability to work with mathematical concepts such as probability
and statistical inference.
- Knowledge of internet software, spreadsheet software, word
processing software, graphics software (e.g., PowerPoint),
bibliographic software e.g. EndNote) and any other applicable
software as may be needed by the job from time to time as it
- Must demonstrate strong experience in relationship-building and
experience in collaborating with large and strategic accounts.
- Proven team player who can focus and continuously reinforce
efforts to meet timelines.
- Exceptional time management skills.
- All candidates must be legally eligible to work in the United
- ***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***
Keywords: ProPharma Group, San Jose , Sr. Medical Writer (Regulatory/Remote) - Consulting Opportunity, Advertising , San Jose, California
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