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Senior Medical Writer (REMOTE)

Lexington, MA 02421

Posted: 01/05/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 532535 Is job remote?: Yes Country: United States

Job Description


Responsible for medical writing activities that support business objectives within cell therapies.

Provides leadership and strategic direction to cross functional project teams to ensure that clinical regulatory documents (including investigator's brochures, study protocols and amendments, study reports, clinical/integrated summaries, clinical overviews, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.

Write and assume primary responsibility for clinical regulatory documents or provide direction to other writers (as needed) to ensure the timely delivery of high quality documents that are scientifically rigorous and logically organized, with accurate data presentation and interpretation; effectively delegates and intervenes as required to maintain optimal productivity; guides document preparation, including coordination of assignments and contract writers, review, and substantive editing of documents; formulates writing approach for assigned regulatory submissions and projects.

Participate in departmental and/or cross-functional initiatives and task forces.

The Lead Medical Writer reports to the Associate Director, Medical Writing, Cell Therapies.

POSITION ACCOUNTABILITIES:
  • Guides medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects.
  • Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management. Writing, development of timelines, project management of deliverables, and participation on project teams. (Performed with minimal oversight)
  • In addition to program responsibilities, the Lead may lead or participate in departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration.
  • Responsible for mentoring of less experienced writers and oversight of external service providers; coordinates the activities of Takeda and contract employees (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.


EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
  • Bachelors degree required; 3 to 5+ years of experience in clinical/pharmaceutical development with directly related medical/scientific writing experience. Oncology writing experience preferred. Cell therapy writing experience a plus.
  • Advanced degree in a relevant scientific/clinical/regulatory field preferred.
  • Global regulatory submission experience preferred.
  • Leadership and mentoring skills.
  • Ability, with minimal oversight, to lead the development, review, and approval of all clinical regulatory document types.
  • Ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams.
  • Strong project management skills including understanding of clinical timelines (study and submission level), working knowledge of the roles of other functional areas and interdependencies among groups; ability to establish detailed timelines for completion of assigned projects and ensure efficient, timely completion.
  • Ability to appropriately manage resourcing across multiple projects with competing workload priorities.
  • Strong oral and written communication skills.
  • Ability to interact effectively with team members to facilitate information exchange (including problem solving and issue resolution). Working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.
  • Excellent working knowledge of writing-related computer software, templates, and electronic document management systems.
Pay Range: 100-130/hr
Salary will be commensurate with experience
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