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Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-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 and review regulatory & other medical writing deliverables independently as per high-quality standards (internal & external) and within expected timelines. Support in building technical & functional expertise within the group by designing & executing robust training programs. Contribute/support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents (including CTD modules) for US FDA, EMEA and rest of the world. Additionally, contribute to manuscripts, abstracts, posters, other techno-commercial documents as needed.
Work with data analysts and statisticians on Real world and other evidence generation projects.
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.
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.
Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.
Support innovation initiatives, including but not limited to automation and process improvement.
Conduct robust training programs for the team & support thought leadership activities in the domain.
Responsible for audit readiness of the department overall. Guide development of the SOPs, work-instructions and other documentation.
Support proactively in business expansion & department operation activities as needed.
Managerial Requirements/ Responsibilities:
Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.
Position Qualification Requirements :
Education:
PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical
Experience:
At least 10- 11 years of experience in medical writing, drug development, clinical research, out of which at least 5 years in core medical writing (regulatory deliverables). Scientific writing (publication/manuscripts etc) experience is desirable but not mandatory.
Required Skills :
Proficient with Microsoft Office Suite. Advance level expertise for MS WORD features and macro relation functionalities.
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.
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 judgment with the ability to make timely and sound decisions.
