job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!
location: Cambridge, Massachusetts
job type: Contract
salary: $97.31 - 114.48 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Executes medical writing activities for projects in accordance with applicable US and international regulatory regulations and requirements under the supervision of the Manager, Medical Writing.
- Assumes primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submissions, and assists the manager in coordinating and evaluating the activities of other contributors (including contract writers and CROs).
- Assists the manager in formulating writing approach, developing timelines, and assessing resource requirements for key documents and regulatory submissions.
- Participates on relevant project teams and task forces, and provides guidance to clinical, safety, nonclinical, and CMC functions on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, company requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
- Prepares documents for submission to FDA or other regulatory agencies, in accordance with team input, with minimal oversight from the manager.
- Serves as lead writer for important regulatory response documents and key components of regulatory submissions.
- As required, coordinates the activities of contract writers (on-site or external), provides review and substantive editing of contributions, and mediates resolution of issues.
- Functions independently on teams and task forces, and provides guidance for document preparation and production to team members from other functional areas (nonclinical, safety, CMC, clinical).
- Provides leadership on functional teams that address requirements or issues related to document preparation and production.
- Assists the manager in formulating writing strategy for key response documents and regulatory submissions, including organization, content, timelines, and resource requirements; may represent medical writing in cross-functional teams or task forces that guide planning and execution of key documents and regulatory submissions.
qualifications: Education & Qualifications
- Bachelor's degree in science, health profession, or journalism.
- At least 5 years experience writing for pharma or biotechnology, including 2-3 years of primary responsibility for document planning and preparation.
- Experience as lead writer for key documents included in major regulatory submissions.
- Advanced degree in science, health profession, or journalism.
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers.
- Ability to address issues and generate solutions in the absence of intervention by management.
skills: FDA, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.