Clinical Medical Writer

PRIMARY RESPONSIBILITIES

- The Aggregate Report Analyst/Medical Writing Author creates documents pertaining to clinical data and post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams.
- Some examples of such document include briefing documents to support meetings with regulatory agencies, periodic safety reports on products that are in development (DSUR, IND Annual Report) or that have been granted regulatory approval (PSURs, NDA PADERs), clinical documents for marketing authorization (new drug) applications (Clinical Overviews and ICH module 2.7)
- Communicate SER's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed
- Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.
- Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts.
- Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
- If leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team.
- Produce documents in conjunction with external vendors.
- Review documents produced by vendors and help evaluate vendor performance.
- Understand relationships and dependencies between documents and analyses produced for regulators including the development RMP, DSUR, PBRER, and ACO.
- Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
- Develop and sustain constructive relationships within other lines including country organizations.
- If assigned by manager, serve as the SER point of contact' for all document issues for a given product or set of products.
- Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line.

SKILLS:

TECHNICAL SKILLS REQUIRED:

- Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
- Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
- Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences
- High fluency in written English and strong functional fluency in spoken English.
- Knowledge of additional languages is an asset.
- Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
- Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy.
- Ability to work well with all levels and roles in cross-functional, global teams.
- Ability to mentor more junior colleagues and external vendors.
- Regulatory knowledge.
- Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
- Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred.
- Proficiency with statistical concepts and ability to carry out statistical analyses is desirable.
- Extensive familiarity with epidemiologic principles and concepts is desirable. education:
- Education: degree or qualification in life sciences (eg, MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field); alternatively, bachelor's or higher degree in field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.
- FDA Regulations, MS Word