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.