SRG, the leader in the Life Sciences human capital industry, is looking for a Medical Writer (Oncology/Rare Disease) to join our client's pharmaceutical clinical research team in New Haven, CT. * This position can be remote, hybrid, or fully onsite.

The Medical Writer is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to achieve goals. The Medical Writer is responsible for a Therapeutic Area, managing all documentation and ensuring consistency as required in order to execute on the writing deliverables across the clinical and regulatory portfolio.

*W2 contract only, no C2C

*Remote optional

MUST HAVES:

• 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry; Bachelor's Degree Required, Advanced Degree preferred.
• Minimum of 8+ years of experience as a medical writer, preparing regulated documents in the pharmaceutical and/or biotech industry, with focus in oncology or rare diseases.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Technical expertise in Microsoft Office, Adobe Acrobat, ability to learn and use document management systems, and familiarity with SharePoint and concepts of structured content management.
• Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.

JOB RESPONSIBILITIES:

• Serve as a Program/Submission expert, to be able to develop strategies/ plans and managing projects, to complete multiple documents for regulatory submissions and clinical deliverables
• Prepare and update documents, including clinical protocols, annual reports, Investigator Brochures, abstracts, clinical study reports, manuscripts, and regulatory authority briefing materials, to support product development
• Coordinate and author regulatory documents (e.g. clinical protocols, annual reports, clinical study reports, Investigator's Brochure), ensuring the coordination and integration of scientific, medical, and regulatory input from development team members.
• Demonstrate mastery of complex writing assignments (e.g., CSRs, protocols, IBs, DSURs, regulatory authority meeting background packages, etc.) across therapeutic areas or multiple projects.
• Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.