Medical Writer

The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. This will be achieved by applying analytical skills, functional literacy, and expertise in document preparation. The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, REMS, key sections of the Investigator's Brochure, the Annual Safety Report and regulatory briefing documents. Achieved through application of team-working approaches this individual will create and foster an environment of partnership with other members of product teams. May also, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external authors.

RESPONSIBILITIES:

- Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.
- For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
- Author documents such as agency briefing documents, key sections of the Investigator's Brochure, the Annual Safety Report and the core data sheet.
- Communicate resource, timeline, and emerging data interpretation issues that have regulatory impact, to the project team and line management.
- Develop and sustain constructive relationships within, and with Development Operations, Clinical, and other key stakeholders.
- Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables).
- Identify resource, timeline, and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management.
- Serve as the point of contact ( go to person) for one or more projects or products.
- Organize and lead an MD Matrix team of authors to deliver all deliverables for each assigned project.
- Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.

SKILLS:

EDUCATION/EXPERIENCE:

- Scientific/medical academic background (eg PharmD/PhD or MSc/BSc with experience),

or equivalent.
- Manager: BS degree and 1 or more years of pharmaceutical experience preferred.
- Senior Manager: An advanced degree preferred and at least 3 years medical writing

experience and/or experience in pharmaceutical development.

SKILLS:

- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills, and also the confidence to guide decision-making for the document content strategy.
- Ability to think creatively and develop strategic plans that demonstrate sound judgment.
- Sound project management and time management skills.
- Ability to interact effectively with all levels/roles of project team members.
- Ability to manage expectations and the time pressures associated with authoring, resolving comments, updating, and finalizing documents.
- Proactive nature in taking on assignments and ability to readily mentor other colleagues in area of expertise.
- Ability to implement systems and processes and suggest process improvements.
- Ability to project manage and appropriately prioritize medium to high volume of work, with short deadlines.
- Ability to complete and turn around high quality outputs with only minimal guidance from management.
- Expert analytical skills, and knowledge of clinical and regulatory guidance.
- Ability to clearly articulate scientific and clinical data in all written and verbal communication.
- Strong functional literacy is desirable: for example a track record of communicating

complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. - MS Word.