Job Description

About the Role:

The Associate Director Medical Writer is primarily responsible for medical writing projects and operations, oversight in high-quality and timely delivery of medical/scientific writing products to clients. The core responsibilities include overseeing MW compliance with applicable regulations, guidelines, developing and implementing best-in-class policies, procedures and practices, overseeing client interactions and contributing to the education and training of MW staff.

The Associate Director Medical Writer will cross-collaborate with colleagues from Operations, Finance, IT and Business Development to ensure business continuity; liaise with alliance partners, external contractors, if applicable; be responsible for ensuring audit inspection readiness.

Minimum Qualifications & Experience:

• Degree in a biomedical field or equivalent.

• Advanced degree(s) in a scientific discipline (Ph.D., MD, or Pharm. D.) preferred.

• 5+ years direct Medical Writing experience in the pharmaceutical industry (i.e. preparation of a broad range of clinical/regulatory documents including Clinical Study Reports, Protocols, Regulatory Submission Modules, Safety Aggregate Reports and Manuscripts).

• Minimum of 3 years of experience leading medical/clinical/scientific writing teams and/or projects, or advanced degree

• Strong project management skills, including the ability to plan and manage projects, create and modify project budgets, develop timelines, allocate resources, and forecast functional workload.

• Demonstrated ability to lead, mentor and influence others to create a positive working environment for the team.

• Strong verbal, written, and interpersonal communication skills.

• Ability to manage multiple and varied tasks with enthusiasm and prioritise workload with attention to detail; ability to work in a fast-paced environment.

• Effective Finance understanding to plan, implement, and evaluate project MW budgets and contracts.

Responsibilities:

• Assist to plan, lead, and advance the MW function.

• Evaluate current processes, assess alignment of safety implementation and compliance with regulatory expectations, guidelines, and mandates.

• Support preparation for regulatory inspections and audits.

• Assist to achieve corporate and functional quality, financial and productivity targets.

• Appraise proposals and budgets, pricing tool and financials for continual success of MW business.

• Ensure MW projects are being managed in line with budgets, scope and agreed timelines to achieve client satisfaction.

• Manage resource planning, assigning, and directing work including staff hiring and terminations.

• Elevate the performance of the team, help the team adapt to work-related challenges, and ensure that team performance remains strong despite the work challenges.

• Conduct regular performance review of line reports; develop and implement personal action plans including identification of training needs of MW team.

• Develop training materials for the team and ensure their knowledge is up to date and consistent with client requirements, current regulations, and guidelines.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.