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Manager of Medical Writing -Remote

Aequor Technologies

Role overview

Qualifications

  • Bachelor's Degree in life science, health-related or pharmaceutical field
  • Minimum of 5 years combined experience in academic/clinical and/or industry setting writing clinical protocols
  • Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations
  • Good interpersonal skills that involve working well in a team environment

Responsibilities

  • Responsible for the development of high quality clinical documents submitted to Regulatory Authorities
  • Collaborates with Global Development Teams and Clinical Development to ensure alignment with program objectives
  • Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors
  • Participates in Global Medical Writing initiatives on clinical development cross-functional teams

Key facts

Hard skills

Other skills

  • Social Skills
  • Teamwork
  • Leadership

About the company

Aequor Technologies logo

Aequor Technologies

Staffing & Recruiting

Since 1998, Aequor has provided exceptional workforce staffing services in multiple industries. Specializing in healthcare, we place nurses, therapists, allied professionals, physicians and medical technicians, as well as staff in the life sciences, technologies and schools. We believe in making a positive impact in the lives of those we serve by inspiring people and empowering growth both personally and professionally, which makes us better as individuals and as a company. We teach our team members to nurture positive and supportive relationships with our clients and candidates by nurturing positive and supportive relationships with each other—from the desk level to the C-suite.Year after year, Aequor is awarded for being one of the best places to work—for the candidates we place in assignments all over the country, and for our internal team, the Aequor Family. The vibrant culture of community and support that welcomes each new team member is the same culture that makes them want to stay. We understand that we’re better in collaboration rather than competition, so we build each other up, respect each other, and show up for one another.As a thriving healthcare staffing firm committed to investing in the resources and tools that ensure a remarkable experience for our clients, candidates and team members, Aequor’s personal approach connects the workforce needs of the industry with the right talent for the job.

Company details

Company typeLarge
IndustryStaffing & Recruiting
Company size201 - 500

Links

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Job description

TITLE: Manager of Medical Writing
100% REMOTE WORK
Oncology experience is preferred,
Regulatory Writing is preferred, other rare disease therapeutic areas are considered .

POSITION SUMMARY:
The Manager of Medical Writing accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, health authority briefing books and clinical summary documents for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.

Responsibilities and Duties:
  • Responsible for the development of high quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.
  • Collaborates with Global Development Teams and Clinical Development to ensure alignment with program objectives.
  • Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors.
  • Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
  • Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
  • Owns and updates assigned Medical Writing SOPs, as necessary.

Educational Requirements:
  • Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
Experience:
  • Minimum of 5 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
  • Previous experience in Medical Writing in clinical drug development, preferably some experience in Oncology.
  • Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
  • Knowledge of template development, document management systems and requirements.
  • Strong working knowledge of Medical Writing requirements and document components.
  • Good interpersonal skills that involves working well in a team environment and the ability to lead others.
  • Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized ).

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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