PRINCIPAL MEDICAL WRITER

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.