Senior Medical Writer

CDMA-Senior Medical Writer Content Creation

Job Description

1. Write, edit, and review clinical publications from Clinical Development and Medical Affairs. This will include vendor selection and management as necessary.

a. Conduct literature searches and interpret scientific literature for internal stakeholders, including competitor assessments, and prepare reports. Publish review articles on pertinent topics.

b. Support gap analysis, situational analysis, and competitor analysis to create strategic and tactical Publication Plans with cross-functional inputs. To timely execute these plans.

c. Facilitate the flow of evidence-based, balanced scientific information in a timely manner to guide therapeutic decision-making by healthcare professionals (therapeutic area, disease state, and product info):

i. Develop and publish Systematic Literature reviews and meta-analyses

ii. Publish reviews based on RWE for value creation iii. Publish blogs, whitepapers, and journal articles to shape policy and build confidence in regulators, payors, prescribers iv. Contribute regularly to the Biocon Biologics website

2. Collaborate with Global Medical Affairs and key R&D functional leads to support key medical communications (MedComm) strategy, including: a. Medical product strategic plan: Support the MedComm plans for each product

b. Scientific platform: support the Global MA Directors on core scientific/medical messages/statements that drive all scientific communications, and a scientific lexicon to enable consistency

c. Tactical plans: Based upon the medical product plan, execute MedComm activities (scientific slide decks, standard response documents, and MSL training materials)

d. Execute Congress activities, making slide decks, posters, congress grids, covering the congress e. Support establishing/maintaining medical information database(s); support MA towards proactive and reactive scientific exchange, and medical information (including Standard Response Documents and direct responses to unsolicited requests)

f. Support medical review of promotional and non-promotional materials for each brand

3. Drive functional and operational excellence by providing oversight/guidance and a. Write/design/update the SOPs, Business Guidance Documents, document templates, style guides, and brand/molecule lexicons

b. Archive and maintain an audit readiness for all Med Com documents and publications.

c. Build up newer competencies and enhance existing competencies; analyze skill/process gaps and bridge the gaps by developing expertise/process maps.

d. Support hiring, training, engaging, and retaining talent. Develop direct reports.