Medical Writer

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Redwood City, CA/Remote

Overview

The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

Principle Duties and Responsibilities Include

  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Participates in scientific communication planning, including development of strategic medical communication plans
  • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Works closely with the study team to reach consensus on timelines for deliverables
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Manages all aspects of outsourced or internal CSR production and ensures project delivery
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
  • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
  • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
  • Align with department management to set strategy for meeting department goals

Candidate Profile

Qualifications/Requirements – We are looking for a candidate with:

  • At minimum, Bachelor’s degree or equivalent in medical-related field or life science. Post-graduate degree preferred
  • Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas; graduate degree (master’s or doctoral) preferred
  • An understanding of the drug development process
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
  • Experience in interacting with cross functional study team members
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
  • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
  • Read, write and speak fluent English; excellent verbal and written communication skills
  • The ability to be productive and successful in an intense work environment
  • Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 25% of work time
To Apply

Interested and qualified candidates should send their resume to info@rezolutebio.com to the attention of Human Resources.

Rezolute (RZLT) currently anticipates the base salary for the Medical Writer role could range from $180,000 to $240,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

  • Health Insurance (Medical / Dental / Vision)
  • Disability, Life & Long-Term Care Insurance
  • Holiday Pay
  • Tracking Free Vacation Program
  • 401(k) Plan Match
  • Educational Assistance Benefit
  • Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.