Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
To author, review regulatory & other medical writing deliverables
independently or with other Sr Medical Writer as per high-quality standards (internal & external) and within expected timelines. Support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
Accountabilities
Position Responsibilities/
- Authoring & review of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents (excluding CTD modules) for US FDA, EMEA and rest of the world.
- Independent authoring and review of manuscripts, abstracts, posters, evidence synthesis projects and other techno-commercial documents as needed.
- Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements).
- Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices (e.g. GPP).
- Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables.
- Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
- Support audit readiness of the department overall. Contribute to development of the SOPs, work-instructions and other documentation.
- Support individual and department development goals for larger business needs.
Education
PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical
Experience
At least 3-5 years of experience in medical writing or flair for writing with proven academic standards. Fair understanding of industry standards and global trends in drug development and medical device domains. Highly proficient in MS Office and other software for authoring and data handling/interpretation. Basic understanding and comfort for use of automation platforms
Required Certifications: Relevant certification is preferable but not
mandatory
- Proficient with Microsoft Office Suite. Mid to Advance level expertise for MS WORD features.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to work independently and as a member of various teams and committees.
- Good judgement with the ability to make timely and sound decisions
